Browse result page of ThPDB2
This is the result page of the browse module of ThPDB2. This page gives the information about the query submitted by the user as per the browse category. Further details of the entries can be seen by clicking on the ID or THPP_ID. Further the user can sort the entries on the basis of various fields by clicking on the respective headers. The user can also download the results in various formats.
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| ID | THPP_ID | Therapeutic Name | Sequence | Molecular Weight | Chemical Formula | Isoelectric Point | Hydrophobicity | Melting Point | Half Life | Description | Disease/Indication | Pharmacodynamics | Mechanism of Action | Toxicity | Metabolism | Absorption | Volume of Distribution | Clearance | Categories | Patent Number | Date of Issue | Date of Expiry | Drug Interaction | Target | Brand Name | Company | Brand Description | Prescribed for | Chemical Name | Formulation | Physical Appearance | Route of Administation | Recommended Dosage | Contraindication | Side Effects | Useful Links 1 | Useful Links 2 | Remarks |
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| 10358 | Th1050 | Pegademase bovine | >Th1050_Pegademase_bovine MAQTPAFNKPKVELHVHLDGAIKPETILYYGRKRGIALPADTPEELQNIIGMDKPLSLPEFLAKFDYYMPAIAGCREAVKRIAYEFVEMKAKDGVVYVEVRYSPHLLANSKVEPIPWNQAEGDLTPDEVVSLVNQGLQEGERDFGVKVRSILCCMRHQPSWSSEVVELCKKYREQTVVAIDLAGDETIEGSSLFPGHVKAYAEAVKSGVHRTVHAGEVGSANVVKEAVDTLKTERLGHGYHTLEDATLYNRLRQENMHFEVCPWSSYLTGAWKPDTEHPVVRFKNDQVNYSLNTDDPLIFKSTLDTDYQMTKNEMGFTEEEFKRLNINAAKSSFLPEDEKKELLDLLYKAYGMPSPASAEQCL | 40788.2 | C1821H2834N484O552S14 | 5.33 | -0.428 | NA | 72-144 hours | Bovine adenosine deaminase derived from bovine intestine that has been extensively pegylated for extended serum half life. | For treatment of adenosine deaminase deficiency | Used to replace deficient or inactive adenosine deaminase which leads to severe combined immunodeficiency disease (SCID). The enzyme is responsible for converting adenosine to inosine. In the absence of adenosine deaminase, the purine substrates adenosine 2-deoxyadenosine and their metabolites are actually toxic to lymphocytes thereby leading to diminished immune function. | Pegademase converts adenosine (toxic) to inosine (less toxic) by deamination. It also converts 2'-deoxyadenosine to 2'-deoxyinosine via deamination. | NA | NA | NA | NA | NA | Adjuvants, Immunologic, Aminohydrolases, Antineoplastic and Immunomodulating Agents, Bovine Intestinal Adenosine Deaminase, Enzymes, Enzymes and Coenzymes, Hydrolases, Nucleoside Deaminases, Pegylated agents, Severe Combined Immunodeficiency | NA | NA | NA | Krystexxa (pegloticase) | Adenosine,Growth factor receptor-bound protein 2 | Adagen | Enzon Inc. | Enzon Inc. | It is used for Treating severe combined immunodeficiency disease (SCID) in certain patients with adenosine deaminase (ADA) deficiency. | (monomethoxypolyethylene glycol succinimidyl) 11-17_ adenosine deaminase | Each ml of ADAGEN injection contains, 250 units of Pegademase bovine, 20 mg of Monobasic sodium phoshphate, USP, 5.58 mg of Dibasic sodium phoshphate, USP, 8.50 mg of Sodiium chloride, USP and q.s. to 0 ml of water for injection. | Isotonic, pyrogen free, Sterile solution, pH 7.2-7.4 | Intramusular Injection | The dosage of ADAGEN (pegademase bovine) Injection should be individualized. The recommended dosing schedule is 10 U/kg for the first dose, 15 U/kg for the second dose, and 20 U/kg for the third dose. The usual maintenance dose is 20 U/kg per week. Further increases of 5 U/kg/week may be necessary, but a maximum single dose of 30 U/kg should not be exceeded. | Allergic | Rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; dark urine; severe or persistent tiredness or weakness; unusual bruising or bleeding | Link | NA | NA |
| 10481 | Th1089 | Palivizumab | >Th1089_Palivizumab QVTLRESGPALVKPTQTLTLTCTFSGFSLSTSGMSVGWIRQPPGKALEWLADIWWDDKKDYNPSLKSRLTISKDTSKNQVVLKVTNMDPADTATYYCARSMITNWYFDVWGAGTTVTVSS | NA | NA | NA | NA | 61 (FAB fr | 18-20 days (in adults) | Humanized, recombinant, monoclonal antibody (IgG1k) directed agaisnt the epitope in the A antigenic site of the F protein of respiratory syncytial virus (RSV). Synagis is a composite of human (95%) and murine (5%) antibody sequences. The human heavy chain sequence is derived from the constant domains of human IgG1 and the variable framework regions of the VH genes Cor (1) and Cess (2). The human light chain sequence is derived from the constant domain of Ck and the variable framework regions of the VL gene K104 withJk-4. Palivizumab is expressed from a stable murine myeloma cell line (NS0). Palivizumab is composed of to heavy chains (50.6 kDa each) and two light chains (27.6 kDa each), contains 1-2% carbohydrate by weight and has a molecular weight of 147.7 kDa ± 1 kDa (MALDI-TOF). | For prophylaxis of respiratory diseases casued by respiratory syncytial virus. | Synagis exhibits neutralizing and fusion-inhibitory activity against Respiratory syncytial virus (RSV). These activities inhibit RSV replication or spread. Synagis is given to prevent the development of lower respiratory tract disease in pediatric patients. | Palivizumab binds to the fusion glycoprotein of RSV. This prevents its binding and uptake by host cellular receptors. | NA | Most likely removed by opsonization via the reticuloendothelial system. | NA | NA | NA | Amino Acids, Peptides, and Proteins,Anti-Infective Agents,Antibodies,Antibodies, Monoclonal,Antibodies, Monoclonal, Humanized,Antiinfectives for Systemic Use,Antiviral Agents,Blood Proteins,Fusion Protein Inhibitors,Globulins,Immune Sera and Immunoglobulins,Immunoglobulins,Immunoproteins,Proteins,Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody,Serum Globulins,Specific Immunoglobulins | CA2197684 | 31-Oct-2000 | 9-Aug-2015 | NA | Fusion glycoprotein F0,Low affinity immunoglobulin gamma Fc region receptor III-B,Complement C1r subcomponent,Complement C1q subcomponent subunit A,Complement C1q subcomponent subunit B,Complement C1q subcomponent subunit C,Low affinity immunoglobulin gamma Fc region receptor III-A,High affinity immunoglobulin gamma Fc receptor I,Low affinity immunoglobulin gamma Fc region receptor II-b | Synagis | MedImmune | MedImmune | Palivizumab inhibits the actions of respiratory syncytial virus (RSV) and helps to prevent the disease | NA | 100 mg single-dose vial of Synagis liquid solution contains 100 mg of palivizumab and also contains chloride (0.5 mg), glycine (0.1 mg), and histidine (3.9 mg), in a volume of 1 mL. | Sterile, preservative-free liquid solution | Intramuscular | recommended dose of Synagis is 15 mg per kg of body weight given monthly by intramuscular injection. The first dose of Synagis should be administered prior to commencement of the RSV season and the remaining doses should be administered monthly throughout the RSV season. Children who develop an RSV infection should continue to receive monthly doses throughout the RSV season. In the northern hemisphere, the RSV season typically commences in November and lasts through April, but it may begin earlier or persist later in certain communities. | indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease.The following points should be considered when prescribing Synagis: Safety and efficacy were established in children with bronchopulmonary dysplasia (BPD), infants with a history of premature birth (less than or equal to 35 weeks gestational age), and children with hemodynamically significant congenital heart disease (CHD). | high fever, ear pain or drainage, tugging at the ear; warmth or swelling of the ear; crying or fussiness, especially while lying down; change in sleeping patterns; poor feeding or loss of appetite; easy bruising or bleeding; or trouble breathing. | Link | NA | NA |
| 10527 | Th1103 | Cosyntropin | >Th1103_Cosyntropin SYSMEHFRWGKPVGKKRRPVKVYP | 2933.437 | C136H210N40O31S | NA | NA | NA | 15 minutes (IV adminstration) | A synthetic peptide identical to the 24-amino acid N-terminal segment of adrenocorticotropic hormone. ACTH. This segment is similar in all species and responsible for biological activity. | For use as a diagnostic agent in the screening of patients presumed to have adrenocortical insufficiency. | Cosyntropin exhibits the full corticosteroidogenic activity of natural ACTH. Various studies have shown that the biologic activity of ACTH resides in the N- terminal portion of the molecule and that the 1-20 amino acid residue is the minimal sequence retaining full activity. Partial or complete loss of activity is noted with progressive shortening of the chain beyond 20 amino acid residue. For example, the decrement from 20 to 19 results in a 70% loss of potency. The pharmacologic profile of Cosyntropin is similar to that of purified natural ACTH. It has been established that 0.25 mg of Cosyntropin will stimulate the adrenal cortex maximally and to the same extent as 25 units of natural ACTH. Cosyntropin has less immunogenic activity than ACTH because the amino acid sequence having most of the antigenic activity of ACTH, i.e., amino acids 25-39, is not present in cosyntropin. The extra-adrenal effects which natural ACTH and Cosyntropin have in common include increased melanotropic activity, increased growth hormone secretion and an adipokinetic effect. These are considered to be without physiological or clinical significance. | Cosyntropin combines with a specific receptor in the adrenal cell plasma membrane and, in patients with normal adrenocortical function, stimulates the initial reaction involved in the synthesis of adrenal steroids (including cortisol, cortisone, weak androgenic substances, and a limited quantity of aldosterone) from cholesterol by increasing the quantity of the substrate within the mitochondria. Cosyntropin does not significantly increase plasma cortisol concentration in patients with primary or secondary adrenocortical insufficiency. | NA | NA | Rapidly absorbed following intramuscular administration. | NA | NA | Hormones and Diagnostic Agents | NA | NA | NA | NA | Adrenocorticotropic hormone receptor | Cortrosyn | Amphastar Pharmaceuticals | Amphastar Pharmaceuticals | CORTROSYN (cosyntropin) for Injection is intended for use as a diagnostic agent in the screening of patients presumed to have ad-renocortical insufficiency. Because of its rapid effect on the adrenal cortex it may be utilized to perform a 30-minute test of adrenal func-tion (plasma cortisol response) as an office or outpatient procedure, using only 2 venipuncture | NA | Box of 10 vials of CORTROSYN (cosyntropin) for Injection 0.25 mg without antimicrobial preservatives | NA | Intravenous, Intravenous infusion, Intramuscular | CORTROSYN (cosyntropin) for Injection may be administered intramuscularly or as a direct Intravenous infusion when used as a rapid screening test of adrenal function. It may also be given as an Intravenous infusion over a 4 to 8 hour period to provide a greater stimulus to the adrenal glands. Doses of CORTROSYN (cosyntropin) 0.25 to 0.75 mg have been used in clinical studies and a maximal response noted with the smallest dose. | The only contraindication to CORTROSYN (cosyntropin) for Injec-tion is a history of a previous adverse reaction to it. | Since CORTROSYN (cosyntropin) for Injection is intended for diag-nostic and not therapeutic use. A rare hypersensitivity reaction usually associated with a pre-existing allergic disease and/or a previous reaction to natural ACTH is possible. Symptoms may include slight whealing with splotchy erythema at the injection site. The other effects such as bradycardia, tachycardia, hypertension, peripheral edema. | NA | NA | NA |
| 10561 | Th1112 | Natural alpha interferon OR multiferon | >Th1112_Natural_alpha_interferon_OR_multiferon CDLPETHSLDNRRTLMLLAQMSRISPSSCLMDRHDFGFPQEEFDGNQFQKAPAISVLHELIQQIFNLFTTKDSSAAWDEDLLDKFCTELYQQLNDLEACVMQEERVGETPLMNADSILAVKKYFRRITLYLTEKKYSPCAWEVVRAEIMRSLSLSTNLQERLRRKE | 19300-22100 | NA | NA | NA | NA | NA | Obtained from the leukocyte fraction of human blood following Sendai virus infection. Interferon alfa contains several naturally occurring IFN-α subtypes and is purified by affinity chromatography. Interferon alpha proteins are mainly involved in innate immune response against viral infection. They come in 13 subtypes that are called IFNA1, IFNA2, IFNA4, IFNA5, IFNA6, IFNA7, IFNA8, IFNA10, IFNA13, IFNA14, IFNA16, IFNA17, IFNA21. Multiferon consists of the 6 major subtypes are IFN-α1, IFN-α2, IFN-α8, IFN-α10, IFN-α14 and IFN-α21. Of these, IFN-α2 and IFN-α14 are glycosylated. | Investigated for use/treatment in hepatitis (viral, C), leukemia (lymphoid), leukemia (myeloid), leukemia (unspecified), and melanoma. | NA | Natural alpha interferon offers multiple subtypes of interferon which may work together as a 'cocktail-in-one', while recombinant versions only exhibit a single subtype. Viragen offers MultiferonT at a cost which is competitive with recombinant interferon regimens. Natural alpha interferon contains the multiple subtype composition that is characteristic of interferon produced by the human body. It is believed that this results in a broader spectrum of specific anti-viral and immunoregulatory activity with the subtypes acting synergistically to give a wide-ranging response. | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | Intron/ Roferon-A | NA | NA | Approved for use in hairy cell leukemia, malignant melanoma, AIDS-related Kaposi's sarcoma, follicular non-Hodgkin's lymphoma. Other uses: Chronic myelogenous leukemia (CML), renal cell cancer, cervical cancer, carcinoid syndrome, medullary thyroid cancer, multiple myeloma, basal and squamous cell skin cancers, low-grade non-Hodgkin's lymphoma, cutaneous T-cell lymphoma (mycosis fungoides). Blood disorders such as: polycythemia vera, essential thrombocytopenia, thrombocytopenia purpura. | NA | NA | NA | Subcutaneous, Intravenous, Intramuscular | NA | Do not take aspirin, products containing aspirin unless your doctor specifically permits this; Do not receive any kind of immunization or vaccination without your doctor's approval while taking interferon alpha; Due to differences in dosage, you should not change brands of interferons. Discuss with your doctor or health care professional if there is a problem with supply. Interferon alfa may cause patients to develop mood or behavioral problems or if you have ever been addicted to drugs or alcohol. Pregnancy category C (use in pregnancy only when benefit to the mother outweighs risk to the fetus). For both men and women: Do not conceive a child (get pregnant) while taking interferon alfa. Barrier methods of contraception, such as condoms, are recommended. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy. Do not breast feed while taking this medication. | Flu-like syndrome: Fever, chills, generalized aches and pains, headache, poor appetite, Fatigue, Low blood counts, anaemia and/or bleeding. Decreases are dose dependent. Temporary blood test abnormalities: low calcium, high glucose, or high triglyceride levels. Increases in blood tests measuring liver function. These return to normal once treatment is discontinued (see liver problems). Weight loss, Hair loss. | Link | NA | NA |
| 10564 | Th1115 | Teicoplanin | NA | 1879.658 | C88H97Cl2N9O33 | NA | NA | NA | 70-100 hrs | Glycopeptide antibiotic. It is a mixture of several compounds majorly teicoplanin A2-1 through A2-5, along with four minor ones, teicoplanin RS-1 through RS-4. They all share a same glycopeptide core, referred to as teicoplanin A3-1, which is a fused ring structure bound by two carbohydrates (mannose and N-acetylglucosamine). The components also contain a third carbohydrate moiety, β-D-glucosamine, and differ only by the length and conformation of a side chain attached to it. | For the treatment of bacterial infections caused by susceptible microorganisms. | Teicoplanin is an antibiotic used in the prophylaxis and treatment of serious infections caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus and Enterococcus faecalis. It is a glycopeptide antiobiotic extracted from Actinoplanes teichomyceticus, with a similar spectrum of activity to vancomycin. Its mechanism of action is to inhibit bacterial cell wall synthesis. Oral teicoplanin has been demonstrated to be effective in the treatment of pseudomembranous colitis and Clostridium difficile-associated diarrhoea, with comparable efficacy to vancomycin. | Teicoplanin inhibits peptidoglycan polymerization, resulting in inhibition of bacterial cell wall synthesis and cell death. | NA | NA | NA | NA | NA | Anti-Bacterial Agents | NA | NA | NA | NA | D-Ala-D-Ala moiety of NAM/NAG peptide subunits of peptidoglycan | Targocid | NPS Pharmaceuticals | NPS Pharmaceuticals | Acts against Gram-postive bacteria including methicillin-resistant Staphylococcus aureus and Enterococcus fecalis. Targocid is indicated in adults and in children from birth for the parenteral treatment of the following infections skin and soft tissue infections, bone and joint infections, hospital acquired pneumonia, community acquired pneumonia, complicated urinary tract infections, infective endocarditis, continuous ambulatory peritoneal dialysis (CAPD), bacteraemia that occurs in association with any of the indications listed above. Targocid is also indicated as an alternative oral treatment for Clostridium difficile infection-associated diarrhoea and colitis. | NA | Each vial of Targocid injection contains 400 mg teicoplanin. The glass vial also contains an inactive ingredient, sodium chloride which is included to minimise stinging and pain when the injection is administered. There are no dyes, gluten or preservatives in Targocid injection. | Light yellow solid | Intramuscular, Intravenous | NA | Serious, life-threatening hypersensitivity reactions, sometimes fatal, have been reported with teicoplanin (e.g. anaphylactic shock). If an allergic reaction to teicoplanin occurs, treatment should be discontinued immediately and appropriate emergency measures should be initiated. Teicoplanin must be administered with caution in patients with known hypersensitivity to vancomycin, as crossed hypersensitivity reactions, including fatal anaphylactic shock, may occur. However, a prior history of red man syndrome with vancomycin is not a contraindication to the use of teicoplanin. | Infusion related reactions, Severe bullous reactions, Nephrotoxicity, Ototoxicity, Superinfection | Link | NA | NA |
| 10649 | Th1134 | Asparaginase erwinia chrysanthemi | >Th1134_Asparaginase_erwinia_chrysanthemi ADKLPNIVILATGGTIAGSAATGTQTTGYKAGALGVDTLINAVPEVKKLANVKGEQFSNMASENMTGDVVLKLSQRVNELLARDDVDGVVITHGTDTVEESAYFLHLTVKSDKPVVFVAAMRPATAISADGPMNLLEAVRVAGDKQSRGRGVMVVLNDRIGSARYITKTNASTLDTFKANEEGYLGVIIGNRIYYQNRIDKLHTTRSVFDVRGLTSLPKVDILYGYQDDPEYLYDAAIQHGVKGIVYAGMGAGSVSVRGIAGMRKAMEKGVVVIRSTRTGNGIVPPDEELPGLVSDSLNPAHARILLMLALTRTSDPKVIQEYFHTY | 140000 | C1546H2510N432O476S9 | NA | NA | NA | 18.2 hours | Erwinaze (asparaginase from Erwiniachryanthemi) is an asparaginase specific enzyme derived from Erwiniachrysanthemi. L-asparaginase is a homo-tetramer with each subnuit having a molecular weight of about 35 kDa. It is an antineoplastic agent and was FDA approved in November 19, 2011. | Asparaginase Erwinia chryanthemi is for the treatment of patients with acute lymphoblastic leukemia (ALL) that have developed a hypersensitivity to Escherichia coli-derivied asparaginase. It is a component of a multi-agent chemotherpeutic regimen for the treatment of the aforementioned disease and is considered second- or third- line treatment in European and American protocols. | NA | Asparaginase Erwinia chrysanthemi catalyzes the deamidation of asparagine to aspartic acid and ammonia, resulting in a reduction in circulating levels of asparagine in the plasma. The mechanism of action of Erwinaze is thought to be based on the inability of leukemic cells to synthesize asparagine due to lack of asparagine synthetase activity, resulting in cytotoxicity specific for leukemic cells that depend on an exogenous source of the amino acid asparagine for their protein metabolism and survival. | There are no known cases of overdose with asparaginase _Erwinia chrysanthemi_.[L149] In clinical trials, the most common adverse effects were hypersensitivity reactions, pancreatic toxicity, blood clots, hemorrhage, and liver toxicity.[L34714] Pancreatitis occurs in 8-14% of pediatric patients, with adolescents at the highest risk for developing this adverse event. Pancreatitis typically occurs after the first few weeks of asparaginase administration, which suggests this complication occurs from an underlying predisposition rather than a cumulative drug effect.[A7464] | Metabolism of asparaginase _Erwinia chrysanthemi_ has not been fully characterized; however, it is suspected to be metabolized into small peptides by catabolic pathways.[L34719] | In patients two to 80 years of age, intramuscular administration of asparaginase _Erwinia chrysanthemi_ 25,000 International Units (IU)/m2 resulted in serum trough asparaginase concentrations = 0.1 IU/mL at either 48-hour (n=35) or 72-hour (n=13) post third dose. 80% of patients evaluted at 48 hours and 38% of patients evaluated at 72 hours had serum asparaginase activity levels > 0.4 IU/mL.[L149] For asparaginase _Erwinia chrysanthemi_ (recombinant)-rywn, the median tmax is 10 hours and the mean absolute bioavailability is 37% in healthy subjects.[L34719] | The volume of distribution of asparaginase _Erwinia chrysanthemi_ can be up to 5 L/m2.[L1448] The geometric mean (%CV) apparent volume of distribution of asparaginase _Erwinia chrysanthemi_ (recombinant)-rywn was 1.48 L/m2 (49%).[L34719] While asparaginases are not detectable in cerebrospinal fluid, asparagine in cerebrospinal fluid is depleted with systemic administration of any formulation of asparaginases.[L1448] | The geometric mean (%CV) apparent clearance of asparaginase _Erwinia chrysanthemi_ (recombinant)-rywn is 0.31 L/hour/m2 (36%).[L34719] | Amidohydrolases,Antineoplastic Agents,Asparaginase,Asparagine-specific Enzyme,Enzymes,Enzymes and Coenzymes,Hepatotoxic Agents,Hydrolases,Narrow Therapeutic Index Drugs,Thyroxine-binding globulin inhibitors | NA | NA | NA | NA | NA | Erwinaze | EUSA Pharma | EUSA Pharma | acute lymphoblastic leukemia | NA | Each vial contains 10,000 International Units of asparaginase Erwinia chrysanthemi, and the following inactive ingredients: glucose monohydrate (5.0 mg), sodium chloride (0.5 mg). | ERWINAZE is supplied as a Sterile, lyophilized, white powder in vials. | Intramuscular | 25,000 International Units/m² | Hypersensitivity reactions to ERWINAZE, including anaphylaxis., pancreatitis with prior L-asparaginase therapy, thrombosis with prior L-asparaginase therapy, hemorrhagic events with prior L-asparaginase therapy. | Hypersensitivity reactions, Pancreatitis, Glucose intolerance, Thrombosis and hemorrhage | Link | NA | NA |
| 10685 | Th1151 | Somatotropin Recombinant | >Th1151_Somatotropin_Recombinant FPTIPLSRLFDNAMLRAHRLHQLAFDTYQEFEEAYIPKEQKYSFLQNPQTSLCFSESIPTPSNREETQQKSNLELLRISLLLIQSWLEPVQFLRSVFANSLVYGASDSNVYDLLKDLEEGIQTLMGRLEDGSPRTGQIFKQTYSKFDTNSHNDDALLKNYGLLYCFRKDMDKVETFLRIVQCRSVEGSCGF | 22129 | C990H1532N262O300S7 | 5.27 | -0.411 | 76 at pH 3 | 21.1 (±5.1) minutes | Somatropin (rDNA origin - nonrefrigerated) is a growth hormone. It works by increasing the flow of water, electrolytes, and nutrients into the bowels. | For treatment of dwarfism, acromegaly and prevention of HIV-induced weight loss | Used in the treatment of dwarfism and growth failure, growth hormone (hGH) stimulates skeletal growth in pediatric patients with growth failure due to a lack of adequate secretion of endogenous GH. Skeletal growth is accomplished at the epiphyseal plates at the ends of a growing bone. Growth and metabolism of epiphyseal plate cells are directly stimulated by GH and one of its mediators, IGF-I (insulin-like growth factor). | hGH binds to the human growth hormone receptor (GHR). Upon binding, hGH causes dimerization of GHR, activation of the GHR-associated JAK2 tyrosine kinase, and tyrosyl phosphorylation of both JAK2 and GHR. These events recruit and/or activate a variety of signaling molecules, including MAP kinases, insulin receptor substrates, phosphatidylinositol 3' phosphate kinase, diacylglycerol, protein kinase C, intracellular calcium, and Stat transcription factors. These signaling molecules contribute to the GH-induced changes in enzymatic activity, transport function, and gene expression that ultimately culminate in changes in growth and metabolism. | NA | NA | NA | NA | NA | Hormone Replacement Agents | US5288703 | 22-02-1994 | 10-Jul-2011 | Concomitant glucocorticoid therapy may inhibit the growth promoting effect of Protropin (somatrem) . If glucocorticoid replacement is required, the dose should be carefully adjusted. | Growth hormone receptor | Protropin | Genentech Inc. | Genentech Inc. | Protropin is indicated only for the long- term treatment of children who have growth failure due to a lack of adequateendogenous growth hormone secretion. Other etiologies of short stature should be excluded. | Growth hormon (human), r-DNA derived | Each 5 mg Protropin vial contains 5 mg (approximately 15 IU) somatrem, lyophilized with 40 mg mannitol, and 1.7 mg sodium phosphates (0.1 mg sodium phosphate monobasic and 1.6 mg sodium phosphate dibasic). | Protropin (somatrem) is a sterile, white, lyophilized powder intended forintramuscular or subcutaneous administration after reconstitution withBacteriostatic Water for Injection, USP (benzyl alcohol preserved). | Intramuscular or subcutaneous administration | A weekly dosage of 0.30 mg/kg (approximately 0.90 IU/kg) of body weight administered by daily intramuscular or subcutaneous injection is recommended. | Protropin (somatrem for injection) should not be used in subjects with closed epiphyses, protropin should not be used in patients with active neoplasia. Growth hormone therapy should be discontinued if evidence of neoplasia develops and when reconstituted with Bacteriostatic Water for Injection, USP (benzyl alcohol preserved) should not be used in patients with a known sensitivity to benzyl alcohol. | As with all protein pharmaceuticals, a small percentage of patients may develop antibodies to the protein. Growth hormone antibody binding capacities below 2 mg/L have not been associated with growth attenuation. In some cases when binding capacity exceeds 2 mg/L, growth attenuation has been observed. Common side effects include headache, fatigue, or muscle pain. | Link | NA | NA |
| 10689 | Th1153 | Alefacept | >Th1153_Alefacept CFSQQIYGVVYGNVTFHVPSNVPLKEVLWKKQKDKVAELENSEFRAFSSFKNRVYLDTVSGSLTIYNLTSSDEDEYEMESPNITDTMKFFLYVLESLPSPTLTCALTNGSIEVQCMIPEHYNSHRGLIMYSWDCPMEQCKRNSTSIYFKMENDLPQKIQCTLSNPLFNTTSSIILTTCIPSSGHSRHRYALIPIPLAVITTCIVLYMNGILKCDRKPDRTNSNRVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPQVKFNWYVDGVQVHNAKTKPREQQYNSTYRVVSVLTVLHQNWLDGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK | 51801.1 | C2306H3594N610O694S26 | 7.86 | -0.432 | NA | 270 hrs | Immunosuppressive dimeric fusion protein that consists of the extracellular CD2-binding portion of the human leukocyte function antigen-3 (LFA-3) linked to the Fc (hinge, CH2 and CH3 domains) portion of human IgG1. Produced by CHO cells, mW is 91.4 kD. | As an immunosuppressive drug, Alefacept can be used for treatment of moderate to severe chronic plaque psoriasis | Interferes with lymphocyte activation by specifically binding to the lymphocyte antigen, CD2, and inhibiting LFA-3/CD2 interaction. Activation of T lymphocytes involving the interaction between LFA-3 on antigen-presenting cells and CD2 on T lymphocytes plays a role in the pathophysiology of chronic plaque psoriasis. Also causes a reduction in subsets of CD2+ T lymphocytes as well as CD4+ and CD8+ T lymphocytes. | Inhibits T-lymphocyte activation and production by binding to the CD2 lymphocyte antigen. | While it has been found to cross the placenta in monkeys, it is not yet known if it also diffuses into breast milk. | NA | Bioavailability after IM administration is 63%. | NA | NA | Dermatologic and Immunosupressive agents | NA | NA | NA | Canakinumab, Rilonacept- Increases immunosupressive effects | T-cell surface antigen CD2,Low affinity immunoglobulin gamma Fc region receptor III-A,Low affinity immunoglobulin gamma Fc region receptor III-B | Amevive | Astellas Pharma Inc. | Astellas Pharma Inc. | AMEVIVE is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. | NA | It contains alefacept (15 mg), citric acid monohydrate (0.06 mg), glycine (5 mg), sodium citrate dehydrate (3.6 mg), and sucrose (12.5 mg) per 0.5 mL of reconstituted solution. | AMEVIVE is supplied as a sterile, white-to-off-white, preservative-free, lyophilized powder | Intramuscular Injection | The recommended dose of AMEVIVE® is 15 mg intramuscularly once weekly for 12 weeks. The CD4+ T lymphocyte counts should be measured before initiating dosing. | AMEVIVE should not be administered to patients infected with HIV. AMEVIVE reduces CD4+ T lymphocyte counts, which might accelerate disease progression or increase complications of disease in these patients | Lymphopenia, Malignancies, Serious Infections reuiring hospitalization, Hypersenstivity reactions. | Link | NA | NA |
| 10690 | Th1154 | OspA lipoprotein | >Th1154_OspA_lipoprotein MKKYLLGIGLILALIACKQNVSSLDEKNSVSVDVPGGMKVLVSKEKNKDGKYDLMATVDNVDLKGTSDKNNGSGILEGVKADKSKVKLTVADDLSKTTLEVLKEDGTVVSRKVTSKDKSTTEAKFNEKGELSEKTMTRANGTTLEYSQMTNEDNAAKAVETLKNGIKFEGNLASGKTAVEIKEGTVTLKREIDKNGKVTVSLNDTASGSKKTASWQESTSTLTISANSKKTKDLVFLTNGTITVQNYDSAGTKLEGSAAEIKKLDELKNALR | 27743.1 | C1198H2012N322O422S2 | 6.72 | -0.652 | NA | 1.2 Hrs (Mammalian reticulocytes,in vitro) | Vaccine against Lyme disease that contains lipoprotein OspA, an outer surface protein of Borrelia burgdorferi sensu stricto ZS7, as expressed by Escherichia coli. Lipoprotein OspA is a single polypeptide chain of 257 amino acids with lipids covalently bonded to the N terminus. It is conjugated with alum (aluminum hydroxide) as an adjuvant. | For prophylactic treatment of Lyme Disease | OspA lipoprotein is a single polypeptide chain of 270 amino acids. It is a vaccination used to prevent Lyme Disease. | OspA lipoprotein, an outer surface protein of the bacteria Borrelia burgdorferi sensu stricto ZS7, is used to stimulate the production of specific antibodies against B. burgdorferi. It is used as a vaccination against Lyme Disease, a disease carried by ticks. | NA | NA | NA | NA | NA | Vaccines | NA | NA | NA | NA | Toll-like receptor 2 | Lymerix | SmithKline Beecham | SmithKline Beecham | YMErix (lipoprotein outer surface a vaccine) is indicated for active immunization against Lyme disease in individuals 15 to 70 years of age. | NA | Each 0.5 mL dose of vaccine consists of 30 mcg of lipoprotein OspA adsorbed onto 0.5 mg aluminum as aluminum hydroxide adjuvant. Each dose of the vaccine preparation contains 10 mM phosphate buffered saline and 2.5 mg of 2-phenoxyethanol, a bacteriostatic agent. | LYMErix (lipoprotein outer surface a vaccine) is supplied as a sterile suspension | Intramuscular Injection | Primary immunization against Lyme disease consists of a 30 mcg/0.5 mL dose of LYMErix (lipoprotein outer surface a vaccine) given at 0, 1 and 12 months. | LYMErix (lipoprotein outer surface a vaccine) is contraindicated in people with known hypersensitivity to any component of the vaccine. | Hyperntension, Diarrhea, Arthritis, Backpain, Depression, Sinusitis, Rashes, Headache, Dizziness, Depression, Fever, Fatigue. | Link | NA | NA |
| 10692 | Th1156 | Abarelix | >Th1156_Abarelix XXXSYNLXPA | 1416.063 | C72H95ClN14O14 | NA | NA | NA | 13.2 ± 3.2 days | Synthetic decapeptide antagonist to gonadotropin releasing hormone (GnRH). It is marketed by Praecis Pharmaceuticals as Plenaxis. Praecis announced in June 2006 that it was voluntarily withdrawing the drug from the market. | For palliative treatment of advanced prostate cancer. | Used in the palliative treatment of advanced prostate cancer. Abarelix is a luteinizing hormone agonist that results in suppression of testicular or follicular steroidogenesis | Abarelix binds to the gonadotropin releasing hormone receptor and acts as a potent inhibitor of gonadotropin secretion | NA | NA | NA | NA | NA | Anti-Testosterone Agents | US5968895 | 19-10-1999 | 12-Nov-2016 | Tacrolimus, Thiothixene, Toremifene, Trimipramine, Voriconazole, Vorinostat, Ziprasidone, Zuclopenthixol- All above drugs cause Additive QTc Prolongation and increases the risk of severe ventricular arrythmias | Gonadotropin-releasing hormone receptor | Plenaxis | Speciality european pharma | Speciality european pharma | Plenaxis is indicated for the palliative treatment of men with advanced symptomatic prostate cancer, in whom LHRH agonist therapy is not appropriate and who refuse surgical castration, and have one or more of the following: (1) risk of neurological compromise due to metastases, (2) ureteral or bladder outlet obstruction due to local encroachment or metastatic disease, or (3) severe bone pain from skeletal metastases persisting on narcotic analgesia. | Abarelix is chemically described as acetyl-D-β-naphthylalanyl-D-4-chlorophenylalanyl- D-3-pyridylalanyl-L-seryl-L-N-methyl-tyrosyl-D-asparagyl-L-leucyl-L-N(ε)-isopropyllysyl- L-prolyl-D-alanyl-amide. | The single-dose vial contains 113 mg of anhydrous free base abarelix peptide (net) supplied in an abarelix CMC complex. This complex also contains 19.1 to 31 mg of CMC. After the vial is reconstituted with 2.2 mL of 0.9% sodium chloride injection | Abarelix for injectable suspension is supplied as a white to off-white sterile dry powder | Intramuscular Injection | The recommended dose of Plenaxis is 100 mg administered intramuscularly to the buttock on Day 1, 15, 29 (week 4) and every 4 weeks thereafter. | Plenaxis is not indicated in women or pediatric patients. In addition, Plenaxis may cause fetal harm if administered to a pregnant woman. | Diarrhea, Dizziness, Flushing of Skin, Headache, Constipation, Sleep Disturbance | Link | NA | NA |
| 10786 | Th1183 | Hepatitis B immune globulin | NA | NA | NA | NA | NA | NA | 22-25 days | Long-term hepatitis B immune globulin (HBIG) has been shown to reduce hepatitis B virus (HBV) reinfection in patients transplanted for hepatitis B. Infection with hepatitis B may lead to hepatocellular carcinoma, a type of liver cancer. Therefore, the hepatitis-B vaccines are cancer-preventing vaccines. According to the Centers for Disease Control and Prevention (CDC), the hepatitis B vaccine was the first anti-cancer vaccine. HBIG is prepared from the plasma of donors who have high antibody levels of the hepatitis B surface antigen. It is extracted from the Cohn fraction II. During the process, viruses are deactivated, and in the final steps, solvents used in the preparation are removed. The preparation is tested for absence of HIV, HCV, herpes virus, and reovirus. | Investigated for use/treatment in hepatitis (viral, B), liver transplant surgery, and pediatric indications. | NA | In countries with high rates of hepatitis B infection, vaccination of newborns has not only reduced the risk of infection, but has also led to marked reduction in liver cancer. | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | HBsAg | Hepagam B | Cangene Bio Pharma Inc. | Cangene Bio Pharma Inc. | HepaGam Bâ„¢, Hepatitis B Immune Globulin Intravenous (Human), is indicated for the prevention of hepatitis B recurrence following liver transplantation, in HBsAg-positive liver transplant patients. | NA | 50 mg/mL | injection, solution | intramuscular; intravenous | Based upon the HepaGam B (hepatitis b immune globulin (human)) clinical trial, patients should receive 20,000 lU/dose [see Clinical Trials in Liver Transplant Patients]. The volume of each 20,000 IU dose should be calculated from the measured potency of the particular lot of HepaGam Bâ„¢ (Hepatitis B Immune Globulin Intravenous [Human]) as stamped on the vial label. The first dose should be administered concurrently with the grafting of the transplanted liver (the anhepatic phase) with subsequent dosing as recommended | Individuals known to have anaphylactic or severe systematic reactions associated with the parenteral administration of human globulin preparations should not receive HepaGam B (hepatitis b immune globulin (human)) , (Hepatitis B Immune Globulin Intravenous [Human]), or any other human immune globulin. HepaGam B (hepatitis b immune globulin (human)) contains less than 40 micro-grams/mL of IgA. Individuals who are deficient in IgA may have the potential to develop IgA antibodies and have an anaphylactoid reaction. The physician must weigh the potential benefit of treatment with HepaGam B (hepatitis b immune globulin (human)) against the potential for hypersensitivity reactions. For postexposure prophylaxis indications, HepaGam B (hepatitis b immune globulin (human)) must be administered intramuscularly only. In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, HepaGam B (hepatitis b immune globulin (human)) should be given only if the expected benefits outweigh the potential risks. | The most common expected adverse drug reactions for intravenous immune globulins like HepaGam B (hepatitis b immune globulin (human)) are chills, fever, headaches, vomiting, allergic reactions, nausea, arthralgia and moderate low back pain. | Link | NA | NA |
| 10787 | Th1183 | Hepatitis B immune globulin | NA | NA | NA | NA | NA | NA | 22-25 days | Long-term hepatitis B immune globulin (HBIG) has been shown to reduce hepatitis B virus (HBV) reinfection in patients transplanted for hepatitis B. Infection with hepatitis B may lead to hepatocellular carcinoma, a type of liver cancer. Therefore, the hepatitis-B vaccines are cancer-preventing vaccines. According to the Centers for Disease Control and Prevention (CDC), the hepatitis B vaccine was the first anti-cancer vaccine. HBIG is prepared from the plasma of donors who have high antibody levels of the hepatitis B surface antigen. It is extracted from the Cohn fraction II. During the process, viruses are deactivated, and in the final steps, solvents used in the preparation are removed. The preparation is tested for absence of HIV, HCV, herpes virus, and reovirus. | Investigated for use/treatment in hepatitis (viral, B), liver transplant surgery, and pediatric indications. | NA | In countries with high rates of hepatitis B infection, vaccination of newborns has not only reduced the risk of infection, but has also led to marked reduction in liver cancer. | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | HBsAg | Hepagam B | Cangene Bio Pharma Inc. | Cangene Bio Pharma Inc. | HepaGam Bâ„¢, Hepatitis B Immune Globulin Intravenous (Human), is indicated for the prevention of hepatitis B recurrence following liver transplantation, in HBsAg-positive liver transplant patients. | NA | 50 mg/mL | injection, solution | intramuscular; intravenous | Based upon the HepaGam B (hepatitis b immune globulin (human)) clinical trial, patients should receive 20,000 lU/dose [see Clinical Trials in Liver Transplant Patients]. The volume of each 20,000 IU dose should be calculated from the measured potency of the particular lot of HepaGam Bâ„¢ (Hepatitis B Immune Globulin Intravenous [Human]) as stamped on the vial label. The first dose should be administered concurrently with the grafting of the transplanted liver (the anhepatic phase) with subsequent dosing as recommended | Individuals known to have anaphylactic or severe systematic reactions associated with the parenteral administration of human globulin preparations should not receive HepaGam B (hepatitis b immune globulin (human)) , (Hepatitis B Immune Globulin Intravenous [Human]), or any other human immune globulin. HepaGam B (hepatitis b immune globulin (human)) contains less than 40 micro-grams/mL of IgA. Individuals who are deficient in IgA may have the potential to develop IgA antibodies and have an anaphylactoid reaction. The physician must weigh the potential benefit of treatment with HepaGam B (hepatitis b immune globulin (human)) against the potential for hypersensitivity reactions. For postexposure prophylaxis indications, HepaGam B (hepatitis b immune globulin (human)) must be administered intramuscularly only. In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, HepaGam B (hepatitis b immune globulin (human)) should be given only if the expected benefits outweigh the potential risks. | The most common expected adverse drug reactions for intravenous immune globulins like HepaGam B (hepatitis b immune globulin (human)) are chills, fever, headaches, vomiting, allergic reactions, nausea, arthralgia and moderate low back pain. | Link | NA | NA |
| 10788 | Th1183 | Hepatitis B immune globulin | NA | NA | NA | NA | NA | NA | 22-25 days | Long-term hepatitis B immune globulin (HBIG) has been shown to reduce hepatitis B virus (HBV) reinfection in patients transplanted for hepatitis B. Infection with hepatitis B may lead to hepatocellular carcinoma, a type of liver cancer. Therefore, the hepatitis-B vaccines are cancer-preventing vaccines. According to the Centers for Disease Control and Prevention (CDC), the hepatitis B vaccine was the first anti-cancer vaccine. HBIG is prepared from the plasma of donors who have high antibody levels of the hepatitis B surface antigen. It is extracted from the Cohn fraction II. During the process, viruses are deactivated, and in the final steps, solvents used in the preparation are removed. The preparation is tested for absence of HIV, HCV, herpes virus, and reovirus. | Investigated for use/treatment in hepatitis (viral, B), liver transplant surgery, and pediatric indications. | NA | In countries with high rates of hepatitis B infection, vaccination of newborns has not only reduced the risk of infection, but has also led to marked reduction in liver cancer. | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | HBsAg | Hepagam B | Cangene Bio Pharma Inc. | Cangene Bio Pharma Inc. | HepaGam Bâ„¢, Hepatitis B Immune Globulin Intravenous (Human), is indicated for the prevention of hepatitis B recurrence following liver transplantation, in HBsAg-positive liver transplant patients. | NA | 312 [iU]/mL | injection, solution | intramuscular; intravenous | Based upon the HepaGam B (hepatitis b immune globulin (human)) clinical trial, patients should receive 20,000 lU/dose [see Clinical Trials in Liver Transplant Patients]. The volume of each 20,000 IU dose should be calculated from the measured potency of the particular lot of HepaGam Bâ„¢ (Hepatitis B Immune Globulin Intravenous [Human]) as stamped on the vial label. The first dose should be administered concurrently with the grafting of the transplanted liver (the anhepatic phase) with subsequent dosing as recommended | Individuals known to have anaphylactic or severe systematic reactions associated with the parenteral administration of human globulin preparations should not receive HepaGam B (hepatitis b immune globulin (human)) , (Hepatitis B Immune Globulin Intravenous [Human]), or any other human immune globulin. HepaGam B (hepatitis b immune globulin (human)) contains less than 40 micro-grams/mL of IgA. Individuals who are deficient in IgA may have the potential to develop IgA antibodies and have an anaphylactoid reaction. The physician must weigh the potential benefit of treatment with HepaGam B (hepatitis b immune globulin (human)) against the potential for hypersensitivity reactions. For postexposure prophylaxis indications, HepaGam B (hepatitis b immune globulin (human)) must be administered intramuscularly only. In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, HepaGam B (hepatitis b immune globulin (human)) should be given only if the expected benefits outweigh the potential risks. | The most common expected adverse drug reactions for intravenous immune globulins like HepaGam B (hepatitis b immune globulin (human)) are chills, fever, headaches, vomiting, allergic reactions, nausea, arthralgia and moderate low back pain. | Link | NA | NA |
| 10789 | Th1183 | Hepatitis B immune globulin | NA | NA | NA | NA | NA | NA | 22-25 days | Long-term hepatitis B immune globulin (HBIG) has been shown to reduce hepatitis B virus (HBV) reinfection in patients transplanted for hepatitis B. Infection with hepatitis B may lead to hepatocellular carcinoma, a type of liver cancer. Therefore, the hepatitis-B vaccines are cancer-preventing vaccines. According to the Centers for Disease Control and Prevention (CDC), the hepatitis B vaccine was the first anti-cancer vaccine. HBIG is prepared from the plasma of donors who have high antibody levels of the hepatitis B surface antigen. It is extracted from the Cohn fraction II. During the process, viruses are deactivated, and in the final steps, solvents used in the preparation are removed. The preparation is tested for absence of HIV, HCV, herpes virus, and reovirus. | Investigated for use/treatment in hepatitis (viral, B), liver transplant surgery, and pediatric indications. | NA | In countries with high rates of hepatitis B infection, vaccination of newborns has not only reduced the risk of infection, but has also led to marked reduction in liver cancer. | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | HBsAg | Hepagam B | Cangene Bio Pharma Inc. | Cangene Bio Pharma Inc. | HepaGam Bâ„¢, Hepatitis B Immune Globulin Intravenous (Human), is indicated for the prevention of hepatitis B recurrence following liver transplantation, in HBsAg-positive liver transplant patients. | NA | 312 [iU]/mL | injection, solution | intramuscular; intravenous | Based upon the HepaGam B (hepatitis b immune globulin (human)) clinical trial, patients should receive 20,000 lU/dose [see Clinical Trials in Liver Transplant Patients]. The volume of each 20,000 IU dose should be calculated from the measured potency of the particular lot of HepaGam Bâ„¢ (Hepatitis B Immune Globulin Intravenous [Human]) as stamped on the vial label. The first dose should be administered concurrently with the grafting of the transplanted liver (the anhepatic phase) with subsequent dosing as recommended | Individuals known to have anaphylactic or severe systematic reactions associated with the parenteral administration of human globulin preparations should not receive HepaGam B (hepatitis b immune globulin (human)) , (Hepatitis B Immune Globulin Intravenous [Human]), or any other human immune globulin. HepaGam B (hepatitis b immune globulin (human)) contains less than 40 micro-grams/mL of IgA. Individuals who are deficient in IgA may have the potential to develop IgA antibodies and have an anaphylactoid reaction. The physician must weigh the potential benefit of treatment with HepaGam B (hepatitis b immune globulin (human)) against the potential for hypersensitivity reactions. For postexposure prophylaxis indications, HepaGam B (hepatitis b immune globulin (human)) must be administered intramuscularly only. In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, HepaGam B (hepatitis b immune globulin (human)) should be given only if the expected benefits outweigh the potential risks. | The most common expected adverse drug reactions for intravenous immune globulins like HepaGam B (hepatitis b immune globulin (human)) are chills, fever, headaches, vomiting, allergic reactions, nausea, arthralgia and moderate low back pain. | Link | NA | NA |
| 10790 | Th1183 | Hepatitis B immune globulin | NA | NA | NA | NA | NA | NA | 22-25 days | Long-term hepatitis B immune globulin (HBIG) has been shown to reduce hepatitis B virus (HBV) reinfection in patients transplanted for hepatitis B. Infection with hepatitis B may lead to hepatocellular carcinoma, a type of liver cancer. Therefore, the hepatitis-B vaccines are cancer-preventing vaccines. According to the Centers for Disease Control and Prevention (CDC), the hepatitis B vaccine was the first anti-cancer vaccine. HBIG is prepared from the plasma of donors who have high antibody levels of the hepatitis B surface antigen. It is extracted from the Cohn fraction II. During the process, viruses are deactivated, and in the final steps, solvents used in the preparation are removed. The preparation is tested for absence of HIV, HCV, herpes virus, and reovirus. | Investigated for use/treatment in hepatitis (viral, B), liver transplant surgery, and pediatric indications. | NA | In countries with high rates of hepatitis B infection, vaccination of newborns has not only reduced the risk of infection, but has also led to marked reduction in liver cancer. | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | HBsAg | Hyperhep B S/d | GRIFOLS USA, LLC | GRIFOLS USA, LLC | Recommendations on post-exposure prophylaxis are based on available efficacy data and on the likelihood of future HBV exposure for the person requiring treatment. In all exposures, a regimen combining Hepatitis B Immune Globulin (Human) with hepatitis B vaccine will provide both short- and long-term protection, will be less costly than the two-dose Hepatitis B Immune Globulin (Human) treatment alone, and is the treatment of choice. Also for post-exposure prophyllaxis for Acute Exposure To Blood Containing HBsAg, Perinatal Exposure Of Infants Born To HBsAg-positive Mothers, Sexual Exposure To An HBsAg-positive Person and Household Exposure To Persons With Acute HBV Infection. | NA | 220 [iU]/mL | Injection | Intramuscular | For Acute Exposure To Blood Containing HBsAg: For greatest effectiveness, passive prophylaxis with Hepatitis B Immune Globulin (Human) should be given as soon as possible after exposure (its value beyond 7 days of exposure is unclear). If Hepatitis B Immune Globulin (Human) is indicated, an injection of 0.06 mL/kg of body weight should be administered intramuscularly as soon as possible after exposure and within 24 hours, if possible. Consult Hepatitis B Vaccine package insert for dosage information regarding that product; for Prophylaxis Of Infants Born To HBsAg And HBeAg Positive Mothers: Efficacy of prophylactic Hepatitis B Immune Globulin (Human) in infants at risk depends on administering Hepatitis B Immune Globulin (Human) on the day of birth. It is therefore vital that HBsAg-positive mothers be identified before delivery; For Sexual Exposure To An HBsAg-positive Person: All susceptible persons whose sex partners have acute hepatitis B infection should receive a single dose of HBIG (0.06 mL/kg) and should begin the hepatitis B vaccine series if prophylaxis can be started within 14 days of the last sexual contact or if sexual contact with the infected person will continue (see Table 2 below). Administering the vaccine with HBIG may improve the efficacy of postexposure treatment. The vaccine has the added advantage of conferring long-lasting protection; For Household Exposure To Persons With Acute HBV Infection: Prophylactic treatment with a 0.5 mL dose of Hepatitis B Immune Globulin (Human) and hepatitis B vaccine is indicated for infants 12 months of age who have been exposed to a primary care-giver who has acute hepatitis B. Prophylaxis for other household contacts of persons with acute HBV infection is not indicated unless they have had identifiable blood exposure to the index patient, such as by sharing toothbrushes or razors. Such exposures should be treated like sexual exposures. If the index patient becomes an HBV carrier, all household contacts should receive hepatitis B vaccine. | NA | Local pain and tenderness at the injection site, urticaria and angioedema may occur; anaphylactic reactions, although rare, have been reported following the injection of human immune globulin preparations. | Link | NA | NA |
| 10791 | Th1183 | Hepatitis B immune globulin | NA | NA | NA | NA | NA | NA | 22-25 days | Long-term hepatitis B immune globulin (HBIG) has been shown to reduce hepatitis B virus (HBV) reinfection in patients transplanted for hepatitis B. Infection with hepatitis B may lead to hepatocellular carcinoma, a type of liver cancer. Therefore, the hepatitis-B vaccines are cancer-preventing vaccines. According to the Centers for Disease Control and Prevention (CDC), the hepatitis B vaccine was the first anti-cancer vaccine. HBIG is prepared from the plasma of donors who have high antibody levels of the hepatitis B surface antigen. It is extracted from the Cohn fraction II. During the process, viruses are deactivated, and in the final steps, solvents used in the preparation are removed. The preparation is tested for absence of HIV, HCV, herpes virus, and reovirus. | Investigated for use/treatment in hepatitis (viral, B), liver transplant surgery, and pediatric indications. | NA | In countries with high rates of hepatitis B infection, vaccination of newborns has not only reduced the risk of infection, but has also led to marked reduction in liver cancer. | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | HBsAg | Nabi-HB | Biotest Pharmaceuticals Corporation | Biotest Pharmaceuticals Corporation | Nabi-HB, Hepatitis B Immune Globulin (Human), is indicated for treatment of acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute HBV infection in the following settings: Acute Exposure to Blood Containing HBsAg; Perinatal Exposure of Infants Born to HBsAg-positive Mothers; Sexual Exposure to HBsAg-positive Persons; Household Exposure to Persons with Acute HBV Infection. | NA | 1560 [iU]/5mL | Injection | Intramuscular | For Acute Exposure To Blood Containing HBsAg: For greatest effectiveness, passive prophylaxis with Hepatitis B Immune Globulin (Human) should be given as soon as possible after exposure (its value beyond 7 days of exposure is unclear). If Hepatitis B Immune Globulin (Human) is indicated, an injection of 0.06 mL/kg of body weight should be administered intramuscularly as soon as possible after exposure and within 24 hours, if possible. Consult Hepatitis B Vaccine package insert for dosage information regarding that product; for Prophylaxis Of Infants Born To HBsAg And HBeAg Positive Mothers: Efficacy of prophylactic Hepatitis B Immune Globulin (Human) in infants at risk depends on administering Hepatitis B Immune Globulin (Human) on the day of birth. It is therefore vital that HBsAg-positive mothers be identified before delivery; For Sexual Exposure To An HBsAg-positive Person: All susceptible persons whose sex partners have acute hepatitis B infection should receive a single dose of HBIG (0.06 mL/kg) and should begin the hepatitis B vaccine series if prophylaxis can be started within 14 days of the last sexual contact or if sexual contact with the infected person will continue (see Table 2 below). Administering the vaccine with HBIG may improve the efficacy of postexposure treatment. The vaccine has the added advantage of conferring long-lasting protection; For Household Exposure To Persons With Acute HBV Infection: Prophylactic treatment with a 0.5 mL dose of Hepatitis B Immune Globulin (Human) and hepatitis B vaccine is indicated for infants 12 months of age who have been exposed to a primary care-giver who has acute hepatitis B. Prophylaxis for other household contacts of persons with acute HBV infection is not indicated unless they have had identifiable blood exposure to the index patient, such as by sharing toothbrushes or razors. Such exposures should be treated like sexual exposures. If the index patient becomes an HBV carrier, all household contacts should receive hepatitis B vaccine. | ndividuals known to have had an anaphylactic or severe systemic reaction to human globulin should not receive Nabi-HB, Hepatitis B Immune Globulin (Human), or any other human immune globulin. Nabi-HB (hepatitis b vaccine recombinant) contains less than 100 micrograms per mL IgA. Individuals who are deficient in IgA may have the potential to develop IgA antibodies and have an anaphylac-toid reaction. The physician must weigh the potential benefit of treatment with Nabi-HB (hepatitis b vaccine recombinant) against the potential for hypersensitivity reactions | The number of patients with reactions related to the administration of Nabi-HB (hepatitis b vaccine recombinant) included local reactions such as erythema 6 (12%) and ache 2 (4%) at the injection site, as well as systemic reactions such as headache 7 (14%), myal-gia 5 (10%), malaise 3 (6%), nausea 2 (4%), and vomiting 1 (2%). The majority (92%) of reactions were reported as mild. The following adverse events were reported in the phar-macokinetics trials and were considered probably related to Nabi-HB (hepatitis b vaccine recombinant) : elevated alkaline phos-phatase 2 (4%), ecchymosis 1 (2%), joint stiffness 1 (2%), elevated AST 1 (2%), decreased WBC 1 (2%), and elevated creatinine 1 (2%). All adverse events were mild in intensity. There were no serious adverse events. No anaphylactic reactions with Nabi-HB (hepatitis b vaccine recombinant) have been reported. However, these reactions, although rare, have been reported following the injection of human immune globulins | Link | NA | NA |
| 10792 | Th1183 | Hepatitis B immune globulin | NA | NA | NA | NA | NA | NA | 22-25 days | Long-term hepatitis B immune globulin (HBIG) has been shown to reduce hepatitis B virus (HBV) reinfection in patients transplanted for hepatitis B. Infection with hepatitis B may lead to hepatocellular carcinoma, a type of liver cancer. Therefore, the hepatitis-B vaccines are cancer-preventing vaccines. According to the Centers for Disease Control and Prevention (CDC), the hepatitis B vaccine was the first anti-cancer vaccine. HBIG is prepared from the plasma of donors who have high antibody levels of the hepatitis B surface antigen. It is extracted from the Cohn fraction II. During the process, viruses are deactivated, and in the final steps, solvents used in the preparation are removed. The preparation is tested for absence of HIV, HCV, herpes virus, and reovirus. | Investigated for use/treatment in hepatitis (viral, B), liver transplant surgery, and pediatric indications. | NA | In countries with high rates of hepatitis B infection, vaccination of newborns has not only reduced the risk of infection, but has also led to marked reduction in liver cancer. | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | HBsAg | Nabi-HB | Biotest Pharmaceuticals Corporation | Biotest Pharmaceuticals Corporation | Nabi-HB, Hepatitis B Immune Globulin (Human), is indicated for treatment of acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute HBV infection in the following settings: Acute Exposure to Blood Containing HBsAg; Perinatal Exposure of Infants Born to HBsAg-positive Mothers; Sexual Exposure to HBsAg-positive Persons; Household Exposure to Persons with Acute HBV Infection. | NA | 312 [iU]/mL | Injection | Intramuscular | For Acute Exposure To Blood Containing HBsAg: For greatest effectiveness, passive prophylaxis with Hepatitis B Immune Globulin (Human) should be given as soon as possible after exposure (its value beyond 7 days of exposure is unclear). If Hepatitis B Immune Globulin (Human) is indicated, an injection of 0.06 mL/kg of body weight should be administered intramuscularly as soon as possible after exposure and within 24 hours, if possible. Consult Hepatitis B Vaccine package insert for dosage information regarding that product; for Prophylaxis Of Infants Born To HBsAg And HBeAg Positive Mothers: Efficacy of prophylactic Hepatitis B Immune Globulin (Human) in infants at risk depends on administering Hepatitis B Immune Globulin (Human) on the day of birth. It is therefore vital that HBsAg-positive mothers be identified before delivery; For Sexual Exposure To An HBsAg-positive Person: All susceptible persons whose sex partners have acute hepatitis B infection should receive a single dose of HBIG (0.06 mL/kg) and should begin the hepatitis B vaccine series if prophylaxis can be started within 14 days of the last sexual contact or if sexual contact with the infected person will continue (see Table 2 below). Administering the vaccine with HBIG may improve the efficacy of postexposure treatment. The vaccine has the added advantage of conferring long-lasting protection; For Household Exposure To Persons With Acute HBV Infection: Prophylactic treatment with a 0.5 mL dose of Hepatitis B Immune Globulin (Human) and hepatitis B vaccine is indicated for infants 12 months of age who have been exposed to a primary care-giver who has acute hepatitis B. Prophylaxis for other household contacts of persons with acute HBV infection is not indicated unless they have had identifiable blood exposure to the index patient, such as by sharing toothbrushes or razors. Such exposures should be treated like sexual exposures. If the index patient becomes an HBV carrier, all household contacts should receive hepatitis B vaccine. | ndividuals known to have had an anaphylactic or severe systemic reaction to human globulin should not receive Nabi-HB, Hepatitis B Immune Globulin (Human), or any other human immune globulin. Nabi-HB (hepatitis b vaccine recombinant) contains less than 100 micrograms per mL IgA. Individuals who are deficient in IgA may have the potential to develop IgA antibodies and have an anaphylac-toid reaction. The physician must weigh the potential benefit of treatment with Nabi-HB (hepatitis b vaccine recombinant) against the potential for hypersensitivity reactions | The number of patients with reactions related to the administration of Nabi-HB (hepatitis b vaccine recombinant) included local reactions such as erythema 6 (12%) and ache 2 (4%) at the injection site, as well as systemic reactions such as headache 7 (14%), myal-gia 5 (10%), malaise 3 (6%), nausea 2 (4%), and vomiting 1 (2%). The majority (92%) of reactions were reported as mild. The following adverse events were reported in the phar-macokinetics trials and were considered probably related to Nabi-HB (hepatitis b vaccine recombinant) : elevated alkaline phos-phatase 2 (4%), ecchymosis 1 (2%), joint stiffness 1 (2%), elevated AST 1 (2%), decreased WBC 1 (2%), and elevated creatinine 1 (2%). All adverse events were mild in intensity. There were no serious adverse events. No anaphylactic reactions with Nabi-HB (hepatitis b vaccine recombinant) have been reported. However, these reactions, although rare, have been reported following the injection of human immune globulins | Link | NA | NA |
| 10795 | Th1185 | Human clostridium tetani toxoid immune globulin | >Th1185_Human_clostridium_tetani_toxoid_immune_globulin EVQLVESGGGVVQPGRSLRLSCAASGFTFNNYAIHWVRQAPGKGLEWVAFISYDGSKNYYADSVKGRFTISRDNSKNTLFLQMNSLRPEDTAIYYCARVLFQQLVLYAPFDIWGQGTMVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPQPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSC | NA | NA | NA | NA | NA | 23 days | NA | It is indicated for prophylaxis against tetanus following injury in patients whose immunization is incomplete or uncertain (see below). It is also indicated, although evidence of effectiveness is limited, in the regimen of treatment of active cases of tetanus. | It supplies passive immunity to those individuals who have low or no immunity to the toxin produced by the tetanus organism, Clostridium tetani. The antibodies act to neutralize the free form of the powerful exotoxin produced by this bacterium. | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | Hypertet S/d | GRIFOLS USA, LLC | GRIFOLS USA, LLC | HyperTET S/D is indicated for prophylaxis against tetanus following injury in patients whose immunization is incomplete or uncertain (see below). It is also indicated, although evidence of effectiveness is limited, in the regimen of treatment of active cases of tetanus. | NA | 250 [iU]/mL | Injection | Intramuscular | NA | NA | Slight soreness at the site of injection and slight temperature elevation may be noted at times. Sensitization to repeated injections of human immunoglobulin is extremely rare. In the course of routine injections of large numbers of persons with immunoglobulin there have been a few isolated occurrences of angio neurotic edema, nephrotic syndrome, and anaphylactic shock after injection. | Link | NA | NA |
| 10796 | Th1186 | Human rabies virus immune globulin | NA | NA | NA | NA | NA | NA | NA | NA | It is indicated for individuals suspected of exposure to rabies, particularly severe exposure, with one exception: persons who have been previously immunized with HDCV Rabies Vaccine in a pre-exposure or postexposure treatment series should receive only vaccine. | NA | It provides passive protection by neutralizing the rabies virus when given to individuals exposed to rabies virus. When a rabies immune globulin dose of 20 IU/kg was given simultaneously with the first dose of rabies vaccine, levels of passive anti-rabies antibody were detected 24 hours after injection in all individuals. There was minimal or no interference with the immune response to the initial and subsequent doses of rabies vaccine, including booster doses. | NA | NA | NA | NA | NA | NA | NA | NA | NA | Live virus vaccines, such as measles vaccine, should not be given for four months following Human rabies virus immune globulin administration because antibodies in the immune globulin preparation may interfere with the immune response to the vaccine. | NA | Hyperab Rabies Immune Globulin Human | Cutter Med & Biol, Division Of Miles Canada Ltd. | Cutter Med & Biol, Division Of Miles Canada Ltd. | NA | NA | 0.165 | Liquid | intramuscular | The recommended dose for HyperRAB S/D is 20 IU/kg (0.133 mL/kg) of body weight given preferably at the time of the first vaccine dose | Hypersensitivity | Fever, pain, soreness, tenderness, or stiffness at the injection site, Skin rash | Link | NA | NA |
| 10797 | Th1186 | Human rabies virus immune globulin | NA | NA | NA | NA | NA | NA | NA | NA | It is indicated for individuals suspected of exposure to rabies, particularly severe exposure, with one exception: persons who have been previously immunized with HDCV Rabies Vaccine in a pre-exposure or postexposure treatment series should receive only vaccine. | NA | It provides passive protection by neutralizing the rabies virus when given to individuals exposed to rabies virus. When a rabies immune globulin dose of 20 IU/kg was given simultaneously with the first dose of rabies vaccine, levels of passive anti-rabies antibody were detected 24 hours after injection in all individuals. There was minimal or no interference with the immune response to the initial and subsequent doses of rabies vaccine, including booster doses. | NA | NA | NA | NA | NA | NA | NA | NA | NA | Live virus vaccines, such as measles vaccine, should not be given for four months following Human rabies virus immune globulin administration because antibodies in the immune globulin preparation may interfere with the immune response to the vaccine. | NA | Hyperrab S/d | Grifols Therapeutics Inc | Grifols Therapeutics Inc | Rabies immune globulin is used together with rabies vaccine to prevent infection caused by the rabies virus. | NA | 150 unit | Solution | intramuscular | The recommended dose for HyperRAB S/D is 20 IU/kg (0.133 mL/kg) of body weight given preferably at the time of the first vaccine dose | Hypersensitivity | Fever, pain, soreness, tenderness, or stiffness at the injection site, Skin rash | Link | NA | NA |
| 10798 | Th1186 | Human rabies virus immune globulin | NA | NA | NA | NA | NA | NA | NA | NA | It is indicated for individuals suspected of exposure to rabies, particularly severe exposure, with one exception: persons who have been previously immunized with HDCV Rabies Vaccine in a pre-exposure or postexposure treatment series should receive only vaccine. | NA | It provides passive protection by neutralizing the rabies virus when given to individuals exposed to rabies virus. When a rabies immune globulin dose of 20 IU/kg was given simultaneously with the first dose of rabies vaccine, levels of passive anti-rabies antibody were detected 24 hours after injection in all individuals. There was minimal or no interference with the immune response to the initial and subsequent doses of rabies vaccine, including booster doses. | NA | NA | NA | NA | NA | NA | NA | NA | NA | Live virus vaccines, such as measles vaccine, should not be given for four months following Human rabies virus immune globulin administration because antibodies in the immune globulin preparation may interfere with the immune response to the vaccine. | NA | Imogam Rabies Inj 150unit/ml | Pasteur mÉrieux Serums Et Vaccins, s.a. | Pasteur mÉrieux Serums Et Vaccins, s.a. | Rabies immune globulin is used together with rabies vaccine to prevent infection caused by the rabies virus. | NA | 151 unit | Clear, pale yellow to light brown liquid | intramuscular | The recommended dose of IMOGAM® Rabies is 20 IU/kg (0.133 mL/kg) of body weight at the time of administration of the first dose of rabies vaccine. | IMOGAM® Rabies should not be administered as repeat doses once rabies vaccination has been in itiated. Repeating the dose may interfere with maximum active immunity expected to develop from the rabies vaccine. | Hypotension, Tachycardia, Nausea, Vomiting, Local reaction, Fever, chills, Allergic type reaction, Anaphylactic shock, General prurit, Rash | Link | NA | NA |
| 10799 | Th1186 | Human rabies virus immune globulin | NA | NA | NA | NA | NA | NA | NA | NA | It is indicated for individuals suspected of exposure to rabies, particularly severe exposure, with one exception: persons who have been previously immunized with HDCV Rabies Vaccine in a pre-exposure or postexposure treatment series should receive only vaccine. | NA | It provides passive protection by neutralizing the rabies virus when given to individuals exposed to rabies virus. When a rabies immune globulin dose of 20 IU/kg was given simultaneously with the first dose of rabies vaccine, levels of passive anti-rabies antibody were detected 24 hours after injection in all individuals. There was minimal or no interference with the immune response to the initial and subsequent doses of rabies vaccine, including booster doses. | NA | NA | NA | NA | NA | NA | NA | NA | NA | Live virus vaccines, such as measles vaccine, should not be given for four months following Human rabies virus immune globulin administration because antibodies in the immune globulin preparation may interfere with the immune response to the vaccine. | NA | Imogam Rabies Pasteurized | Sanofi Pasteur Limited | Sanofi Pasteur Limited | It is indicated for post-exposure prophylaxis in persons suspected of exposure to rabies, who have not previously received a complete immunization regimen with a cell culture produced rabies vaccine. | NA | Human proteins (100-160 mg) containing IgG-class human rabies immune globulins with a minimum titre of 150 IU/mL. Supplied in 2 mL vial s (300 IU) and 10 mL vials (1,500 IU). | Solution | intramuscular | The recommended dose of IMOGAM® Rabies Pasteurized is 20 IU/kg (0.133 mL/kg) of body weight at the time of administration of the first dose of rabies vaccine. | IMOGAM® Rabies Pasteurized should not be administered as repeat doses once rabies vaccination has been in itiated. Repeating the dose may interfere with maximum active immunity expected to develop from the rabies vaccine. | Hypotension, Tachycardia, Nausea, Vomiting, Local reaction, Fever, chills, Allergic type reaction, Anaphylactic shock, General prurit, Rash | Link | NA | NA |
| 10800 | Th1187 | Human Rho(D) immune globulin | NA | NA | NA | NA | NA | NA | The half life is 16 ± 4 days following IV administration and 18 ± 5 days following IM administration. | Human Rho(D) immune globulin is a medicine given by intramuscular injection that is used to prevent the immunological condition known as Rh disease (or hemolytic disease of newborn). Human Rho(D) immune globulin is produced by an ion-exchange chromatography isolation procedure, using pooled plasma obtained by plasmapheresis of immunized Rh0(D)-negative US donors. | NA | NA | It acts by suppressing the immune response of Rh-negative individuals to Rh-positive red blood cells. The mechanism of action is unknown. RhoGAM, MICRhoGAM and other Rho(D) Immune Globulin (Human) products are not effective in altering the course or consequences of Rh immunization once it has occurred. | Most serious adverse reactions in patients with ITP include intravascular hemolysis, anemia, acute renal insufficiency, and death. In patients treated for Rh isoimmunization suppression, common adverse effects include nausea, dizziness, headache, pain at injection site and malaise. Common adverse effects in patients with ITP include chills, pyrexia, mild extravascular hemolysis and headache. | Rho (D) immune globulin is expected to undergo nonspecific catabolism. | In patients undergoing therapy for Rh isoimmunization suppression, Rho(D) immune globulin titers were detected in all women up to at least 9 weeks following either intravenous or intramuscular administration. Following intravenous administration of a single 1500 IU (300 mcg) dose, peak serum levels of Rh0(D) immune globulin ranged from 62 to 84 ng/mL after first day. The levels ranged from 7 to 46 ng/mL and were achieved between 2 and 7 days following intramuscular injection. The absolute bioavailability achieved following IM administration is 69%. | A single dose of 300ug Rho(D) Immune Globulin through intramuscular injection displays a Vd of 8.59L [L805]. | Mean systemic clearance following IV administration is 0.20 ±0.03 mL/min. Mean apparent clearance following IM administration is 0.29 ± 0.12 mL/min. | NA | NA | NA | NA | NA | Rhesus blood group D antigen | Hyp Rho D Inj 16.5% | Cutter Med & Biol, Division Of Miles Canada Ltd. | Cutter Med & Biol, Division Of Miles Canada Ltd. | NA | NA | 0.165 | liquid | Intramuscular | NA | NA | NA | Link | NA | NA |
| 10801 | Th1187 | Human Rho(D) immune globulin | NA | NA | NA | NA | NA | NA | The half life is 16 ± 4 days following IV administration and 18 ± 5 days following IM administration. | Human Rho(D) immune globulin is a medicine given by intramuscular injection that is used to prevent the immunological condition known as Rh disease (or hemolytic disease of newborn). Human Rho(D) immune globulin is produced by an ion-exchange chromatography isolation procedure, using pooled plasma obtained by plasmapheresis of immunized Rh0(D)-negative US donors. | NA | NA | It acts by suppressing the immune response of Rh-negative individuals to Rh-positive red blood cells. The mechanism of action is unknown. RhoGAM, MICRhoGAM and other Rho(D) Immune Globulin (Human) products are not effective in altering the course or consequences of Rh immunization once it has occurred. | Most serious adverse reactions in patients with ITP include intravascular hemolysis, anemia, acute renal insufficiency, and death. In patients treated for Rh isoimmunization suppression, common adverse effects include nausea, dizziness, headache, pain at injection site and malaise. Common adverse effects in patients with ITP include chills, pyrexia, mild extravascular hemolysis and headache. | Rho (D) immune globulin is expected to undergo nonspecific catabolism. | In patients undergoing therapy for Rh isoimmunization suppression, Rho(D) immune globulin titers were detected in all women up to at least 9 weeks following either intravenous or intramuscular administration. Following intravenous administration of a single 1500 IU (300 mcg) dose, peak serum levels of Rh0(D) immune globulin ranged from 62 to 84 ng/mL after first day. The levels ranged from 7 to 46 ng/mL and were achieved between 2 and 7 days following intramuscular injection. The absolute bioavailability achieved following IM administration is 69%. | A single dose of 300ug Rho(D) Immune Globulin through intramuscular injection displays a Vd of 8.59L [L805]. | Mean systemic clearance following IV administration is 0.20 ±0.03 mL/min. Mean apparent clearance following IM administration is 0.29 ± 0.12 mL/min. | NA | NA | NA | NA | NA | Rhesus blood group D antigen | Hyperrho S/d Full Dose | GRIFOLS USA, LLC | GRIFOLS USA, LLC | NA | NA | 1500 [iU]/1 | Soution | Intramuscular | NA | NA | NA | Link | NA | NA |
| 10802 | Th1187 | Human Rho(D) immune globulin | NA | NA | NA | NA | NA | NA | The half life is 16 ± 4 days following IV administration and 18 ± 5 days following IM administration. | Human Rho(D) immune globulin is a medicine given by intramuscular injection that is used to prevent the immunological condition known as Rh disease (or hemolytic disease of newborn). Human Rho(D) immune globulin is produced by an ion-exchange chromatography isolation procedure, using pooled plasma obtained by plasmapheresis of immunized Rh0(D)-negative US donors. | NA | NA | It acts by suppressing the immune response of Rh-negative individuals to Rh-positive red blood cells. The mechanism of action is unknown. RhoGAM, MICRhoGAM and other Rho(D) Immune Globulin (Human) products are not effective in altering the course or consequences of Rh immunization once it has occurred. | Most serious adverse reactions in patients with ITP include intravascular hemolysis, anemia, acute renal insufficiency, and death. In patients treated for Rh isoimmunization suppression, common adverse effects include nausea, dizziness, headache, pain at injection site and malaise. Common adverse effects in patients with ITP include chills, pyrexia, mild extravascular hemolysis and headache. | Rho (D) immune globulin is expected to undergo nonspecific catabolism. | In patients undergoing therapy for Rh isoimmunization suppression, Rho(D) immune globulin titers were detected in all women up to at least 9 weeks following either intravenous or intramuscular administration. Following intravenous administration of a single 1500 IU (300 mcg) dose, peak serum levels of Rh0(D) immune globulin ranged from 62 to 84 ng/mL after first day. The levels ranged from 7 to 46 ng/mL and were achieved between 2 and 7 days following intramuscular injection. The absolute bioavailability achieved following IM administration is 69%. | A single dose of 300ug Rho(D) Immune Globulin through intramuscular injection displays a Vd of 8.59L [L805]. | Mean systemic clearance following IV administration is 0.20 ±0.03 mL/min. Mean apparent clearance following IM administration is 0.29 ± 0.12 mL/min. | NA | NA | NA | NA | NA | Rhesus blood group D antigen | Hyperrho S/d Mini-dose | GRIFOLS USA, LLC | GRIFOLS USA, LLC | NA | NA | 250 [iU]/1 | Solution | Intramuscular | NA | NA | NA | Link | NA | NA |
| 10803 | Th1187 | Human Rho(D) immune globulin | NA | NA | NA | NA | NA | NA | The half life is 16 ± 4 days following IV administration and 18 ± 5 days following IM administration. | Human Rho(D) immune globulin is a medicine given by intramuscular injection that is used to prevent the immunological condition known as Rh disease (or hemolytic disease of newborn). Human Rho(D) immune globulin is produced by an ion-exchange chromatography isolation procedure, using pooled plasma obtained by plasmapheresis of immunized Rh0(D)-negative US donors. | NA | NA | It acts by suppressing the immune response of Rh-negative individuals to Rh-positive red blood cells. The mechanism of action is unknown. RhoGAM, MICRhoGAM and other Rho(D) Immune Globulin (Human) products are not effective in altering the course or consequences of Rh immunization once it has occurred. | Most serious adverse reactions in patients with ITP include intravascular hemolysis, anemia, acute renal insufficiency, and death. In patients treated for Rh isoimmunization suppression, common adverse effects include nausea, dizziness, headache, pain at injection site and malaise. Common adverse effects in patients with ITP include chills, pyrexia, mild extravascular hemolysis and headache. | Rho (D) immune globulin is expected to undergo nonspecific catabolism. | In patients undergoing therapy for Rh isoimmunization suppression, Rho(D) immune globulin titers were detected in all women up to at least 9 weeks following either intravenous or intramuscular administration. Following intravenous administration of a single 1500 IU (300 mcg) dose, peak serum levels of Rh0(D) immune globulin ranged from 62 to 84 ng/mL after first day. The levels ranged from 7 to 46 ng/mL and were achieved between 2 and 7 days following intramuscular injection. The absolute bioavailability achieved following IM administration is 69%. | A single dose of 300ug Rho(D) Immune Globulin through intramuscular injection displays a Vd of 8.59L [L805]. | Mean systemic clearance following IV administration is 0.20 ±0.03 mL/min. Mean apparent clearance following IM administration is 0.29 ± 0.12 mL/min. | NA | NA | NA | NA | NA | Rhesus blood group D antigen | Micrhogam Ultra-filtered Plus | Kedrion Melville, Inc. | Kedrion Melville, Inc. | NA | NA | 50 ug/1 | injection, solution | Intramuscular | NA | NA | NA | Link | NA | NA |
| 10804 | Th1187 | Human Rho(D) immune globulin | NA | NA | NA | NA | NA | NA | The half life is 16 ± 4 days following IV administration and 18 ± 5 days following IM administration. | Human Rho(D) immune globulin is a medicine given by intramuscular injection that is used to prevent the immunological condition known as Rh disease (or hemolytic disease of newborn). Human Rho(D) immune globulin is produced by an ion-exchange chromatography isolation procedure, using pooled plasma obtained by plasmapheresis of immunized Rh0(D)-negative US donors. | NA | NA | It acts by suppressing the immune response of Rh-negative individuals to Rh-positive red blood cells. The mechanism of action is unknown. RhoGAM, MICRhoGAM and other Rho(D) Immune Globulin (Human) products are not effective in altering the course or consequences of Rh immunization once it has occurred. | Most serious adverse reactions in patients with ITP include intravascular hemolysis, anemia, acute renal insufficiency, and death. In patients treated for Rh isoimmunization suppression, common adverse effects include nausea, dizziness, headache, pain at injection site and malaise. Common adverse effects in patients with ITP include chills, pyrexia, mild extravascular hemolysis and headache. | Rho (D) immune globulin is expected to undergo nonspecific catabolism. | In patients undergoing therapy for Rh isoimmunization suppression, Rho(D) immune globulin titers were detected in all women up to at least 9 weeks following either intravenous or intramuscular administration. Following intravenous administration of a single 1500 IU (300 mcg) dose, peak serum levels of Rh0(D) immune globulin ranged from 62 to 84 ng/mL after first day. The levels ranged from 7 to 46 ng/mL and were achieved between 2 and 7 days following intramuscular injection. The absolute bioavailability achieved following IM administration is 69%. | A single dose of 300ug Rho(D) Immune Globulin through intramuscular injection displays a Vd of 8.59L [L805]. | Mean systemic clearance following IV administration is 0.20 ±0.03 mL/min. Mean apparent clearance following IM administration is 0.29 ± 0.12 mL/min. | NA | NA | NA | NA | NA | Rhesus blood group D antigen | Rhogam Ultra-filtered Plus | Kedrion Melville, Inc. | Kedrion Melville, Inc. | NA | NA | 300 ug/1 | injection, solution | Intramuscular | NA | NA | NA | Link | NA | NA |
| 10805 | Th1187 | Human Rho(D) immune globulin | NA | NA | NA | NA | NA | NA | The half life is 16 ± 4 days following IV administration and 18 ± 5 days following IM administration. | Human Rho(D) immune globulin is a medicine given by intramuscular injection that is used to prevent the immunological condition known as Rh disease (or hemolytic disease of newborn). Human Rho(D) immune globulin is produced by an ion-exchange chromatography isolation procedure, using pooled plasma obtained by plasmapheresis of immunized Rh0(D)-negative US donors. | NA | NA | It acts by suppressing the immune response of Rh-negative individuals to Rh-positive red blood cells. The mechanism of action is unknown. RhoGAM, MICRhoGAM and other Rho(D) Immune Globulin (Human) products are not effective in altering the course or consequences of Rh immunization once it has occurred. | Most serious adverse reactions in patients with ITP include intravascular hemolysis, anemia, acute renal insufficiency, and death. In patients treated for Rh isoimmunization suppression, common adverse effects include nausea, dizziness, headache, pain at injection site and malaise. Common adverse effects in patients with ITP include chills, pyrexia, mild extravascular hemolysis and headache. | Rho (D) immune globulin is expected to undergo nonspecific catabolism. | In patients undergoing therapy for Rh isoimmunization suppression, Rho(D) immune globulin titers were detected in all women up to at least 9 weeks following either intravenous or intramuscular administration. Following intravenous administration of a single 1500 IU (300 mcg) dose, peak serum levels of Rh0(D) immune globulin ranged from 62 to 84 ng/mL after first day. The levels ranged from 7 to 46 ng/mL and were achieved between 2 and 7 days following intramuscular injection. The absolute bioavailability achieved following IM administration is 69%. | A single dose of 300ug Rho(D) Immune Globulin through intramuscular injection displays a Vd of 8.59L [L805]. | Mean systemic clearance following IV administration is 0.20 ±0.03 mL/min. Mean apparent clearance following IM administration is 0.29 ± 0.12 mL/min. | NA | NA | NA | NA | NA | Rhesus blood group D antigen | Rhophylac | Csl Behring Ag | Csl Behring Ag | NA | NA | 1500 [iU]/2mL | solution | intramuscular; intravenous | NA | NA | NA | Link | NA | NA |
| 10806 | Th1187 | Human Rho(D) immune globulin | NA | NA | NA | NA | NA | NA | The half life is 16 ± 4 days following IV administration and 18 ± 5 days following IM administration. | Human Rho(D) immune globulin is a medicine given by intramuscular injection that is used to prevent the immunological condition known as Rh disease (or hemolytic disease of newborn). Human Rho(D) immune globulin is produced by an ion-exchange chromatography isolation procedure, using pooled plasma obtained by plasmapheresis of immunized Rh0(D)-negative US donors. | NA | NA | It acts by suppressing the immune response of Rh-negative individuals to Rh-positive red blood cells. The mechanism of action is unknown. RhoGAM, MICRhoGAM and other Rho(D) Immune Globulin (Human) products are not effective in altering the course or consequences of Rh immunization once it has occurred. | Most serious adverse reactions in patients with ITP include intravascular hemolysis, anemia, acute renal insufficiency, and death. In patients treated for Rh isoimmunization suppression, common adverse effects include nausea, dizziness, headache, pain at injection site and malaise. Common adverse effects in patients with ITP include chills, pyrexia, mild extravascular hemolysis and headache. | Rho (D) immune globulin is expected to undergo nonspecific catabolism. | In patients undergoing therapy for Rh isoimmunization suppression, Rho(D) immune globulin titers were detected in all women up to at least 9 weeks following either intravenous or intramuscular administration. Following intravenous administration of a single 1500 IU (300 mcg) dose, peak serum levels of Rh0(D) immune globulin ranged from 62 to 84 ng/mL after first day. The levels ranged from 7 to 46 ng/mL and were achieved between 2 and 7 days following intramuscular injection. The absolute bioavailability achieved following IM administration is 69%. | A single dose of 300ug Rho(D) Immune Globulin through intramuscular injection displays a Vd of 8.59L [L805]. | Mean systemic clearance following IV administration is 0.20 ±0.03 mL/min. Mean apparent clearance following IM administration is 0.29 ± 0.12 mL/min. | NA | NA | NA | NA | NA | Rhesus blood group D antigen | Winrho Sdf | Aptevo Biotherapeutics Llc | Aptevo Biotherapeutics Llc | NA | NA | 5000 unit; 1500 unit; 600 unit | kit | intramuscular; intravenous | NA | NA | NA | Link | NA | NA |
| 10807 | Th1187 | Human Rho(D) immune globulin | NA | NA | NA | NA | NA | NA | The half life is 16 ± 4 days following IV administration and 18 ± 5 days following IM administration. | Human Rho(D) immune globulin is a medicine given by intramuscular injection that is used to prevent the immunological condition known as Rh disease (or hemolytic disease of newborn). Human Rho(D) immune globulin is produced by an ion-exchange chromatography isolation procedure, using pooled plasma obtained by plasmapheresis of immunized Rh0(D)-negative US donors. | NA | NA | It acts by suppressing the immune response of Rh-negative individuals to Rh-positive red blood cells. The mechanism of action is unknown. RhoGAM, MICRhoGAM and other Rho(D) Immune Globulin (Human) products are not effective in altering the course or consequences of Rh immunization once it has occurred. | Most serious adverse reactions in patients with ITP include intravascular hemolysis, anemia, acute renal insufficiency, and death. In patients treated for Rh isoimmunization suppression, common adverse effects include nausea, dizziness, headache, pain at injection site and malaise. Common adverse effects in patients with ITP include chills, pyrexia, mild extravascular hemolysis and headache. | Rho (D) immune globulin is expected to undergo nonspecific catabolism. | In patients undergoing therapy for Rh isoimmunization suppression, Rho(D) immune globulin titers were detected in all women up to at least 9 weeks following either intravenous or intramuscular administration. Following intravenous administration of a single 1500 IU (300 mcg) dose, peak serum levels of Rh0(D) immune globulin ranged from 62 to 84 ng/mL after first day. The levels ranged from 7 to 46 ng/mL and were achieved between 2 and 7 days following intramuscular injection. The absolute bioavailability achieved following IM administration is 69%. | A single dose of 300ug Rho(D) Immune Globulin through intramuscular injection displays a Vd of 8.59L [L805]. | Mean systemic clearance following IV administration is 0.20 ±0.03 mL/min. Mean apparent clearance following IM administration is 0.29 ± 0.12 mL/min. | NA | NA | NA | NA | NA | Rhesus blood group D antigen | Winrho Sdf (liquid Formulation) | Aptevo Biotherapeutics Llc | Aptevo Biotherapeutics Llc | NA | NA | 15000 unit | liquid | intramuscular; intravenous | NA | NA | NA | Link | NA | NA |
| 10812 | Th1190 | Immune Globulin Human | >Th1190_Immune_Globulin_Human PSALTQPPSASGSLGQSVTISCTGTSSDVGGYNYVSWYQQHAGKAPKVIIYEVNKRPSGVPDRFSGSKSGNTASLTVSGLQAEDEADYYCSSYEGSDNFVFGTGTKVTVLGQPKANPTVTLFPPSSEELQANKATEVCLISDFYPGAVTVAWKADGSPVKAGVETTKPSKQSNNKYAASSYLSLTPEQWKSHRSYSCQVTHEGSTVEKTVAPTECSPLVLQESGPGLVKPSEALSLTCTVSGDSINTILYYWSWIRQPPGKGLEWIGYIYYSGSTYGNPSLKSRVTISVNTSKNQFYSKLSSVTAADTAVYYCARVPLVVNPWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPQPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPQVKFNWYVDGVQVHNAKTKPREQQYNSTYRVVSVLTVLHQNWLDGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSL | 142682.3 | C6332H9826N1692O1980S42 | 8.13 | -0.331 | 61 °C (FAB fragment), 71 °C (whole mAb) | >20 hours (mammalian reticulocytes, in vitro). | Intravenous immunoglobulin (IVIg) is a mixture of IgG1 and other antibodies derived from healthy human plasma via Cohn fractionation. The purification process includes cold alcohol fractionation, polyethylene glycol precipitation, and ion exchange chromatography. IVIg contains the same distribution of IgG antibody subclasses as is found in the general human population. IgG subclasses are fully represented in the following proportions: 70.3% IgG1, 24.7% IgG2, 3.1% IgG3, and 1.9% IgG4. IVIg is used in the treatment of immunodeficiencies, as well as autoimmune and inflammatory disorders. | IVIg is used in the treatment of immunodeficiencies, as well as autoimmune and inflammatory disorders. These indications includes idiopathic thrombocytopenic purpura, Kawasaki disease, hypogammaglobulinemia, B cell chronic lymphocytic leukemia, bone marrow transplant complications, Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy (CIDP), multiple sclerosis, rheumatoid arthritis, myesthenia gravis, Wiskott–Aldrich syndrome and inflammatory skin diseases. | Used as a replacement therapy in inherited humoral immunodeficiency disorders such as severe combined immunodeficiency syndrome, x-linked agammaglobulinemia, and Wiskott-Aldrich Syndrome. The immunoglobulins target, bind and kill bacterial cells as well as viral particles. IgG is the monomeric immunoglobulin of which there are four subclasses (IgG1, IgG2, IgG3 and IgG4) in differing abundances (66%, 23%, 7% and 4%). IgAs represent about 15% of the immunoglobulins in the blood. These target inhaled or ingested pathogens. | IVIg interacts with a number of different components of the immune system, including cytokines, complement, Fc receptors and several cell surface immunocompetent molecules. IVIg also impacts different effector cells of the immune system (B and T lymphocytes, dendritic cells, etc.) and regulates a wide range of genes. Its main mechanism of actions are believed to be Fc-dependent and F(ab')2-dependent. IVIg competitively blocks gamma Fc receptors, preventing the binding and ingestion of phagocytes and suppressing platelet depletion. IVIg contains a number of different antobodies, which prevent infection by attaching to the surface of invading pathogens and aiding in their disposal before they can infect cells. Antibodies remove pathogens via complement activation, agglutination or precipitation, pathogen receptor blocking, macrophage “tagging†or neutralization (via binding) of pathogen toxins. Intact IVIg and F(ab′)2 fragments of IVIg can also neutralize the activity of various autoantibodies. By triggering the production of interleukin-1 receptor antagonist, IVIg modulates of the production of cytokines and cytokine antagonists. It also prevents the generation of the C5b-9 membrane attack complex and subsequent complement-mediated tissue damage by binding active complement components. | NA | NA | NA | NA | NA | Immunologic Factors; Immunosuppressive Agents; Anti-Infective Agents | NA | NA | NA | Estradiol may increase the thrombogenic activities of Intravenous Immunoglobulin; Estropipate may increase the thrombogenic activities of Intravenous Immunoglobulin. | High affinity immunoglobulin gamma Fc receptor I; High affinity immunoglobulin gamma Fc receptor IB; Low affinity immunoglobulin gamma Fc region receptor II-a; Low affinity immunoglobulin gamma Fc region receptor II-b; Low affinity immunoglobulin gamma Fc region receptor II-c; Low affinity immunoglobulin gamma Fc region receptor III-A; Low affinity immunoglobulin gamma Fc region receptor III-B; Complement C3; Complement C4-A; Complement C4-B; Complement C5. | NA | NA | NA | NA | NA | .165 g/mL; 10 g/100mL; 12 g/1; 3 g/1; v; 1 g/10mL; 10 g/100mL; 5 g/50mL; .05 g/mL; 100 mg/mL | Injection; Injection, powder, lyophilized, for solution; Injection, solution. | intramuscular; intravenous; subcutaneous | NA | NA | NA | NA | NA | NA |
| 10821 | Th1190 | Immune Globulin Human | >Th1190_Immune_Globulin_Human PSALTQPPSASGSLGQSVTISCTGTSSDVGGYNYVSWYQQHAGKAPKVIIYEVNKRPSGVPDRFSGSKSGNTASLTVSGLQAEDEADYYCSSYEGSDNFVFGTGTKVTVLGQPKANPTVTLFPPSSEELQANKATEVCLISDFYPGAVTVAWKADGSPVKAGVETTKPSKQSNNKYAASSYLSLTPEQWKSHRSYSCQVTHEGSTVEKTVAPTECSPLVLQESGPGLVKPSEALSLTCTVSGDSINTILYYWSWIRQPPGKGLEWIGYIYYSGSTYGNPSLKSRVTISVNTSKNQFYSKLSSVTAADTAVYYCARVPLVVNPWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPQPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPQVKFNWYVDGVQVHNAKTKPREQQYNSTYRVVSVLTVLHQNWLDGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSL | 142682.3 | C6332H9826N1692O1980S51 | 8.13 | -0.331 | 61 °C (FAB fragment), 71 °C (whole mAb) | >20 hours (mammalian reticulocytes, in vitro). | Intravenous immunoglobulin (IVIg) is a mixture of IgG1 and other antibodies derived from healthy human plasma via Cohn fractionation. The purification process includes cold alcohol fractionation, polyethylene glycol precipitation, and ion exchange chromatography. IVIg contains the same distribution of IgG antibody subclasses as is found in the general human population. IgG subclasses are fully represented in the following proportions: 70.3% IgG1, 24.7% IgG2, 3.1% IgG3, and 1.9% IgG4. IVIg is used in the treatment of immunodeficiencies, as well as autoimmune and inflammatory disorders. | IVIg is used in the treatment of immunodeficiencies, as well as autoimmune and inflammatory disorders. These indications includes idiopathic thrombocytopenic purpura, Kawasaki disease, hypogammaglobulinemia, B cell chronic lymphocytic leukemia, bone marrow transplant complications, Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy (CIDP), multiple sclerosis, rheumatoid arthritis, myesthenia gravis, Wiskott–Aldrich syndrome and inflammatory skin diseases. | Used as a replacement therapy in inherited humoral immunodeficiency disorders such as severe combined immunodeficiency syndrome, x-linked agammaglobulinemia, and Wiskott-Aldrich Syndrome. The immunoglobulins target, bind and kill bacterial cells as well as viral particles. IgG is the monomeric immunoglobulin of which there are four subclasses (IgG1, IgG2, IgG3 and IgG4) in differing abundances (66%, 23%, 7% and 4%). IgAs represent about 15% of the immunoglobulins in the blood. These target inhaled or ingested pathogens. | IVIg interacts with a number of different components of the immune system, including cytokines, complement, Fc receptors and several cell surface immunocompetent molecules. IVIg also impacts different effector cells of the immune system (B and T lymphocytes, dendritic cells, etc.) and regulates a wide range of genes. Its main mechanism of actions are believed to be Fc-dependent and F(ab')2-dependent. IVIg competitively blocks gamma Fc receptors, preventing the binding and ingestion of phagocytes and suppressing platelet depletion. IVIg contains a number of different antobodies, which prevent infection by attaching to the surface of invading pathogens and aiding in their disposal before they can infect cells. Antibodies remove pathogens via complement activation, agglutination or precipitation, pathogen receptor blocking, macrophage “tagging†or neutralization (via binding) of pathogen toxins. Intact IVIg and F(ab′)2 fragments of IVIg can also neutralize the activity of various autoantibodies. By triggering the production of interleukin-1 receptor antagonist, IVIg modulates of the production of cytokines and cytokine antagonists. It also prevents the generation of the C5b-9 membrane attack complex and subsequent complement-mediated tissue damage by binding active complement components. | NA | NA | NA | NA | NA | Immunologic Factors; Immunosuppressive Agents; Anti-Infective Agents | NA | NA | NA | Estradiol may increase the thrombogenic activities of Intravenous Immunoglobulin; Estropipate may increase the thrombogenic activities of Intravenous Immunoglobulin. | High affinity immunoglobulin gamma Fc receptor I; High affinity immunoglobulin gamma Fc receptor IB; Low affinity immunoglobulin gamma Fc region receptor II-a; Low affinity immunoglobulin gamma Fc region receptor II-b; Low affinity immunoglobulin gamma Fc region receptor II-c; Low affinity immunoglobulin gamma Fc region receptor III-A; Low affinity immunoglobulin gamma Fc region receptor III-B; Complement C3; Complement C4-A; Complement C4-B; Complement C5. | Gamastan | Cutter Med & Biol, Division Of Miles Canada Ltd. | Cutter Med & Biol, Division Of Miles Canada Ltd. | Passive immunization should be considered when vaccines for active immunization are not available, or in situations when vaccine has not been used prior to exposure to the infective agent or is contraindicated | NA | 0.165 | liquid | Intramuscular | For Hepatitis A- GamaSTAN® S/D in a dose of 0.02 mL/kg is recommended for household and institutional hepatitis A case contacts.; For measles- GamaSTAN® S/D should be given in a dose of 0.25 mL/kg to prevent or modify measles in a susceptible person exposed fewer than 6 days previously (1,2). A susceptible child who is exposed to measles and who is immunocompromised should receive a dose of 0.5 mL/kg (maximum dose, 15 mL) of GamaSTAN® S/D immediately (3). The dosage of Immune Globulin (Human) for exposed individuals who have underlying malignant disease should be 0.5 mL/kg or 15 mL maximum; For varicella- If Varicella-Zoster Immune Globulin (Human) is unavailable, GamaSTAN® S/D at a dose of 0.6 to 1.2 mL/kg, promptly given, may also modify varicella; For Rubella- Some studies suggest that the use of GamaSTAN® S/D in exposed, susceptible women can lessen the likelihood of infection and fetal damage; therefore, GamaSTAN® S/D at a dose of 0.55 mL/kg may benefit those women who will not consider a therapeutic abortion. | GamaSTAN® S/D should not be given to patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the Dosage Forms, Composition And Packaging section. GamaSTAN® S/D should not be given to persons with isolated immunoglobulin A (IgA) deficiency. Such persons have the potential for developing antibodies to IgA and could have anaphylactic reactions to subsequent administration of blood products that contain IgA (7). GamaSTAN® S/D should not be administered to patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections. | Local pain and tenderness at the injection site, urticaria, and angioedema may occur. Anaphylactic reactions, although rare, have been reported following the injection of human immune globulin preparations. Anaphylaxis is more likely to occur if GamaSTAN® S/D is given intravenously; therefore, GamaSTAN® S/D must be administered only intramuscularly. | Link | NA | NA |
| 10822 | Th1190 | Immune Globulin Human | >Th1190_Immune_Globulin_Human PSALTQPPSASGSLGQSVTISCTGTSSDVGGYNYVSWYQQHAGKAPKVIIYEVNKRPSGVPDRFSGSKSGNTASLTVSGLQAEDEADYYCSSYEGSDNFVFGTGTKVTVLGQPKANPTVTLFPPSSEELQANKATEVCLISDFYPGAVTVAWKADGSPVKAGVETTKPSKQSNNKYAASSYLSLTPEQWKSHRSYSCQVTHEGSTVEKTVAPTECSPLVLQESGPGLVKPSEALSLTCTVSGDSINTILYYWSWIRQPPGKGLEWIGYIYYSGSTYGNPSLKSRVTISVNTSKNQFYSKLSSVTAADTAVYYCARVPLVVNPWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPQPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPQVKFNWYVDGVQVHNAKTKPREQQYNSTYRVVSVLTVLHQNWLDGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSL | 142682.3 | C6332H9826N1692O1980S52 | 8.13 | -0.331 | 61 °C (FAB fragment), 71 °C (whole mAb) | >20 hours (mammalian reticulocytes, in vitro). | Intravenous immunoglobulin (IVIg) is a mixture of IgG1 and other antibodies derived from healthy human plasma via Cohn fractionation. The purification process includes cold alcohol fractionation, polyethylene glycol precipitation, and ion exchange chromatography. IVIg contains the same distribution of IgG antibody subclasses as is found in the general human population. IgG subclasses are fully represented in the following proportions: 70.3% IgG1, 24.7% IgG2, 3.1% IgG3, and 1.9% IgG4. IVIg is used in the treatment of immunodeficiencies, as well as autoimmune and inflammatory disorders. | IVIg is used in the treatment of immunodeficiencies, as well as autoimmune and inflammatory disorders. These indications includes idiopathic thrombocytopenic purpura, Kawasaki disease, hypogammaglobulinemia, B cell chronic lymphocytic leukemia, bone marrow transplant complications, Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy (CIDP), multiple sclerosis, rheumatoid arthritis, myesthenia gravis, Wiskott–Aldrich syndrome and inflammatory skin diseases. | Used as a replacement therapy in inherited humoral immunodeficiency disorders such as severe combined immunodeficiency syndrome, x-linked agammaglobulinemia, and Wiskott-Aldrich Syndrome. The immunoglobulins target, bind and kill bacterial cells as well as viral particles. IgG is the monomeric immunoglobulin of which there are four subclasses (IgG1, IgG2, IgG3 and IgG4) in differing abundances (66%, 23%, 7% and 4%). IgAs represent about 15% of the immunoglobulins in the blood. These target inhaled or ingested pathogens. | IVIg interacts with a number of different components of the immune system, including cytokines, complement, Fc receptors and several cell surface immunocompetent molecules. IVIg also impacts different effector cells of the immune system (B and T lymphocytes, dendritic cells, etc.) and regulates a wide range of genes. Its main mechanism of actions are believed to be Fc-dependent and F(ab')2-dependent. IVIg competitively blocks gamma Fc receptors, preventing the binding and ingestion of phagocytes and suppressing platelet depletion. IVIg contains a number of different antobodies, which prevent infection by attaching to the surface of invading pathogens and aiding in their disposal before they can infect cells. Antibodies remove pathogens via complement activation, agglutination or precipitation, pathogen receptor blocking, macrophage “tagging†or neutralization (via binding) of pathogen toxins. Intact IVIg and F(ab′)2 fragments of IVIg can also neutralize the activity of various autoantibodies. By triggering the production of interleukin-1 receptor antagonist, IVIg modulates of the production of cytokines and cytokine antagonists. It also prevents the generation of the C5b-9 membrane attack complex and subsequent complement-mediated tissue damage by binding active complement components. | NA | NA | NA | NA | NA | Immunologic Factors; Immunosuppressive Agents; Anti-Infective Agents | NA | NA | NA | Estradiol may increase the thrombogenic activities of Intravenous Immunoglobulin; Estropipate may increase the thrombogenic activities of Intravenous Immunoglobulin. | High affinity immunoglobulin gamma Fc receptor I; High affinity immunoglobulin gamma Fc receptor IB; Low affinity immunoglobulin gamma Fc region receptor II-a; Low affinity immunoglobulin gamma Fc region receptor II-b; Low affinity immunoglobulin gamma Fc region receptor II-c; Low affinity immunoglobulin gamma Fc region receptor III-A; Low affinity immunoglobulin gamma Fc region receptor III-B; Complement C3; Complement C4-A; Complement C4-B; Complement C5. | Gamastan S/d | GRIFOLS USA, LLC | GRIFOLS USA, LLC | Passive immunization should be considered when vaccines for active immunization are not available, or in situations when vaccine has not been used prior to exposure to the infective agent or is contraindicated | NA | .165 g/mL | injection | Intramuscular | For Hepatitis A- GamaSTAN® S/D in a dose of 0.02 mL/kg is recommended for household and institutional hepatitis A case contacts.; For measles- GamaSTAN® S/D should be given in a dose of 0.25 mL/kg to prevent or modify measles in a susceptible person exposed fewer than 6 days previously (1,2). A susceptible child who is exposed to measles and who is immunocompromised should receive a dose of 0.5 mL/kg (maximum dose, 15 mL) of GamaSTAN® S/D immediately (3). The dosage of Immune Globulin (Human) for exposed individuals who have underlying malignant disease should be 0.5 mL/kg or 15 mL maximum; For varicella- If Varicella-Zoster Immune Globulin (Human) is unavailable, GamaSTAN® S/D at a dose of 0.6 to 1.2 mL/kg, promptly given, may also modify varicella; For Rubella- Some studies suggest that the use of GamaSTAN® S/D in exposed, susceptible women can lessen the likelihood of infection and fetal damage; therefore, GamaSTAN® S/D at a dose of 0.55 mL/kg may benefit those women who will not consider a therapeutic abortion. | GamaSTAN® S/D should not be given to patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the Dosage Forms, Composition And Packaging section. GamaSTAN® S/D should not be given to persons with isolated immunoglobulin A (IgA) deficiency. Such persons have the potential for developing antibodies to IgA and could have anaphylactic reactions to subsequent administration of blood products that contain IgA (7). GamaSTAN® S/D should not be administered to patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections. | Local pain and tenderness at the injection site, urticaria, and angioedema may occur. Anaphylactic reactions, although rare, have been reported following the injection of human immune globulin preparations. Anaphylaxis is more likely to occur if GamaSTAN® S/D is given intravenously; therefore, GamaSTAN® S/D must be administered only intramuscularly. | Link | NA | NA |
| 10862 | Th1223 | Chorionic Gonadotropin (Human) | >Th1223_Chorionic_Gonadotropin_(Human) APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS | NA | NA | NA | NA | NA | NA | Human chorionic gonadotropin (HCG), a polypeptide hormone produced by the human placenta. Endogenously produced HCG interacts with the LHCG receptor of the ovary and promotes the maintenance of the corpus luteum during the beginning of pregnancy. This allows the corpus luteum to continuously secrete the hormone progesterone during the first trimester, which is required for maintenance of the uterus and prevents menstruation. In males, HCG also stimulates the production of gonadal steroid hormones by stimulating the interstitial cells (Leydig cells) of the testis to produce androgens. HCG is composed of an alpha and a beta sub-unit. The alpha sub-unit is essentially identical to the alpha sub units of the human pituitary gonadotropins, luteinizing hormone (LH) and follicle-stimulating hormone (FSH), as well as to the alpha sub-unit of human thyroid-stimulating hormone (TSH), while the beta sub units of these hormones differ in amino acid sequence. As a drug product, chorionic gonadotropin is a highly purified pyrogen-free preparation obtained from the urine of pregnant females. | For the treatment of prepubertal cryptorchidism (not due to anatomical obstruction), for the treatment of selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males and for the induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure, and who has been appropriately pretreated with human menotropins. | he action of HCG is virtually identical to that of pituitary LH, although HCG appears to have a small degree of FSH activity as well. It stimulates production of gonadal steroid hormones by stimulating the interstitial cells (Leydig cells) of the testis to produce androgens and the corpus luteum of the ovary to produce progesterone. | NA | NA | NA | NA | NA | NA | Hormones | US6706681 | 16-03-2004 | 16-03-2021 | NA | Lutropin-choriogonadotropic hormone receptor | Pregnyl | Physicians Total Care, Inc. | Physicians Total Care, Inc. | It is used for treating fertility problems in certain women who have not gone through menopause. Treating certain testicular development problems and stimulating the development of secondary sexual characteristics in certain patients. It is also used to treat boys 4 to 9 years old who have testicles that have not moved into the scrotum. | NA | Available in vials containing 10,000 USP units of sterile dried powder with 5 mg monobasic sodium phosphate and 4.4 mg dibasic sodium phosphate. If required, pH is adjusted with sodium hydroxide and/or phosphoric acid. Each package also contains a 10-mL vial of solvent containing: water for injection with 0.56% sodium chloride and 0.9% BENZYL ALCOHOL, WHICH IS NOT FOR USE IN NEWBORNS. If required, pH is adjusted with sodium hydroxide and/or hydrochloric acid. | Injection, Solution | Intramuscular, Subcutaneous | 4000 USP units 3 times weekly for 3 weeks. | Precocious puberty, prostatic carcinoma or other androgen-dependent neoplasm, prior allergic reaction to HCG. | Headache, irritability, restlessness, depression, fatigue, edema, precocious puberty, gynecomastia, pain at the site of injection. | Link | NA | NA |
| 10868 | Th1229 | Hepatitis A Vaccine | NA | NA | NA | NA | NA | NA | Evaluation of pharmacokinetic properties is not required for vaccines. | Two types of HAV vaccines are currently available internationally: 1. Formaldehyde-inactivated vaccines: Inactivated HAV vaccines are used in most countries. Monovalent inactivated HAV vaccines are available in paediatric dose (0.5 ml) for children aged 1 year to 15 years, and in adult dose (1 ml). 2. Live attenuated vaccines (based on H2 or LA-1 HAV strains): These vaccines are manufactured and used mainly in China and India. Inactivated hepatitis A vaccines are safe and highly effective. Traditionally, a two-dose schedule is recommended, particularly in travellers at substantial risk of contracting hepatitis A and in immunocompromised individuals. However, in healthy individuals, comparable effectiveness has been achieved with a single dose. The Chinese live attenuated hepatitis A vaccines have been shown to be safe and highly protective (95%) against clinical infection for at least 3 years. Among the adverse effects from Hepatitis A vaccine injection are fatigue, fever > 99.5°F (37.5°C), induration, redness, and swelling of the injection site and malaise. Anorexia and nausea could be possible side effects. | Hepatitis A vaccine is indicated for active immunization against disease caused by hepatitis A virus (HAV). It is approved for use in persons 12 months of age and older. Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV. HAVRIX® will not prevent hepatitis infection caused by other agents such as hepatitis B virus, hepatitis C virus, hepatitis E virus or other pathogens known to infect the liver. In areas of low to intermediate prevalence of hepatitis A, immunization with HAVRIX® is particularly recommended in subjects who are, or will be, at increased risk of infection such as: * Travelers: Persons traveling to areas where the prevalence of hepatitis A is high. These areas include Africa, Asia, the Mediterranean basin, the Middle East, Central and South America. * Armed Forces: Armed Forces personnel who travel to higher endemicity areas or to areas where hygiene is poor have an increased risk of HAV infection. Active immunization is indicated for these individuals. * Persons for whom Hepatitis A is an Occupational Hazard: These include employees in day-care centres, nursing, medical and paramedical personnel in hospitals and institutions, especially gastroenterology and pediatric units, sewage workers, and food handlers, among others. * Persons for whom there is an Increased Risk of Transmission of Hepatitis A: e.g. homosexuals, persons with multiple sexual partners, abusers of injectable drugs, hemophiliac patients. * Contacts of Infected Persons: Since virus shedding of infected persons may occur for a prolonged period, active immunization of close contacts is recommended. * Specific Population Groups known to have Higher Incidence of Hepatitis A: e.g. North American Indians, Inuits, recognized community-wide HAV epidemics. * Subjects with chronic liver disease or who are at risk of developing chronic liver disease e.g. Hepatitis B (HB) and Hepatitis C (HC) chronic carriers and alcohol abusers. | Elevation of Anti-Hepatitis A antibodies which gives protection against Hepatitis A infection. | The hepatitis A virus belongs to the picornavirus family. It is one of several hepatitis viruses that cause systemic disease with pathology in the liver. The incubation period for hepatitis A averages 28 days (range: 15 to 50 days). The course of hepatitis A infection is extremely variable, ranging from asymptomatic infection to icteric hepatitis and death. The presence of antibodies to HAV confers protection against hepatitis A infection. However, the lowest titer needed to confer protection has not been determined. | LD50 information for the hepatitis A vaccine is not readily available in the literature. The prescribing information for the inactivated Hepatitis A vaccine indicates that postmarketing reports of adverse effects following an overdose with the vaccine that were similar to those that are normally expected. This may include pain or redness at the injection site, headache, irritability, appetite loss, and other symptoms. Prescribing information also advises contacting the local poison control center in the case of an overdose.[L338] | NA | NA | NA | NA | Actively Acquired Immunity,Inactivated Hepatitis A Virus Vaccine,Vaccines | NA | NA | NA | NA | B-lymphocytes | Avaxim | Sanofi Pasteur Limited | Sanofi Pasteur Limited | AVAXIM is indicated for active immunisation against infection caused by hepatitis A virus in susceptible adults and adolescents of 16 years of age and above. | NA | Each 0.5 mL dose of sterile, whitish, cloudy suspension, contains 80 antigen units of inactivated hepatitis A virus. Nonmedicinal ingredients: aluminum hydroxide (expressed as aluminum): 0.15 mg; 2-phenoxyethanol: 2.5 µL; formaldehyde: 12.5 µg; polysorbate 80 in less than 750 µg; medium 199, water for injection up to: 0.5 mL; neomycin: trace amounts. | Suspension | Intramuscular | NA | Hypersensitivity to the active substance(s) or to any of the excipients. | diarrhea, drowsiness, fatigue, fever, generally feeling unwell, headache, irritability, loss of appetite, muscle or joint achiness, nausea or vomiting, pain and redness at the injection site, swelling or hard lump at the injection site, weakness might occur as side reaction | Link | NA | NA |
| 10869 | Th1229 | Hepatitis A Vaccine | NA | NA | NA | NA | NA | NA | Evaluation of pharmacokinetic properties is not required for vaccines. | Two types of HAV vaccines are currently available internationally: 1. Formaldehyde-inactivated vaccines: Inactivated HAV vaccines are used in most countries. Monovalent inactivated HAV vaccines are available in paediatric dose (0.5 ml) for children aged 1 year to 15 years, and in adult dose (1 ml). 2. Live attenuated vaccines (based on H2 or LA-1 HAV strains): These vaccines are manufactured and used mainly in China and India. Inactivated hepatitis A vaccines are safe and highly effective. Traditionally, a two-dose schedule is recommended, particularly in travellers at substantial risk of contracting hepatitis A and in immunocompromised individuals. However, in healthy individuals, comparable effectiveness has been achieved with a single dose. The Chinese live attenuated hepatitis A vaccines have been shown to be safe and highly protective (95%) against clinical infection for at least 3 years. Among the adverse effects from Hepatitis A vaccine injection are fatigue, fever > 99.5°F (37.5°C), induration, redness, and swelling of the injection site and malaise. Anorexia and nausea could be possible side effects. | Hepatitis A vaccine is indicated for active immunization against disease caused by hepatitis A virus (HAV). It is approved for use in persons 12 months of age and older. Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV. HAVRIX® will not prevent hepatitis infection caused by other agents such as hepatitis B virus, hepatitis C virus, hepatitis E virus or other pathogens known to infect the liver. In areas of low to intermediate prevalence of hepatitis A, immunization with HAVRIX® is particularly recommended in subjects who are, or will be, at increased risk of infection such as: * Travelers: Persons traveling to areas where the prevalence of hepatitis A is high. These areas include Africa, Asia, the Mediterranean basin, the Middle East, Central and South America. * Armed Forces: Armed Forces personnel who travel to higher endemicity areas or to areas where hygiene is poor have an increased risk of HAV infection. Active immunization is indicated for these individuals. * Persons for whom Hepatitis A is an Occupational Hazard: These include employees in day-care centres, nursing, medical and paramedical personnel in hospitals and institutions, especially gastroenterology and pediatric units, sewage workers, and food handlers, among others. * Persons for whom there is an Increased Risk of Transmission of Hepatitis A: e.g. homosexuals, persons with multiple sexual partners, abusers of injectable drugs, hemophiliac patients. * Contacts of Infected Persons: Since virus shedding of infected persons may occur for a prolonged period, active immunization of close contacts is recommended. * Specific Population Groups known to have Higher Incidence of Hepatitis A: e.g. North American Indians, Inuits, recognized community-wide HAV epidemics. * Subjects with chronic liver disease or who are at risk of developing chronic liver disease e.g. Hepatitis B (HB) and Hepatitis C (HC) chronic carriers and alcohol abusers. | Elevation of Anti-Hepatitis A antibodies which gives protection against Hepatitis A infection. | The hepatitis A virus belongs to the picornavirus family. It is one of several hepatitis viruses that cause systemic disease with pathology in the liver. The incubation period for hepatitis A averages 28 days (range: 15 to 50 days). The course of hepatitis A infection is extremely variable, ranging from asymptomatic infection to icteric hepatitis and death. The presence of antibodies to HAV confers protection against hepatitis A infection. However, the lowest titer needed to confer protection has not been determined. | LD50 information for the hepatitis A vaccine is not readily available in the literature. The prescribing information for the inactivated Hepatitis A vaccine indicates that postmarketing reports of adverse effects following an overdose with the vaccine that were similar to those that are normally expected. This may include pain or redness at the injection site, headache, irritability, appetite loss, and other symptoms. Prescribing information also advises contacting the local poison control center in the case of an overdose.[L338] | NA | NA | NA | NA | Actively Acquired Immunity,Inactivated Hepatitis A Virus Vaccine,Vaccines | NA | NA | NA | NA | B-lymphocytes | Havrix | Dispensing Solutions, Inc. | Dispensing Solutions, Inc. | HAVRIX® is indicated for active immunization against disease caused by hepatitis A virus (HAV) | NA | Each 1-mL adult dose of vaccine contains 1440 EL.U. of viral antigen, adsorbed on 0.5 mg of aluminum as aluminum hydroxide. It contains few excipients: Amino acid supplement (0.3% w/v) in a phosphate-buffered saline solution and polysorbate 20 (0.05 mg/mL). | Suspension | Intramuscular | Primary immunization for children and adolescents (12 months through 18 years of age) consists of a single 0.5-mL dose and a 0.5-mL booster dose administered anytime between 6 and 12 months later. | Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis A containing vaccine, or to any component of HAVRIX, including neomycin, is a contraindication to administration of HAVRIX | Injection site hematoma, upper respiratory tract infections, Insomnia etc | Link | NA | NA |
| 10870 | Th1230 | Human Varicella-Zoster Immune Globulin | NA | NA | NA | NA | NA | NA | Human Varicella-Zoster Immunoglobulin has a half-life of about 18-24 days following intravenous administration and 24-30 days following intramuscular administration. | Human Varicella-Zoster Immune Globulin is a solvent/detergent-treated sterile liquid preparation of purified human immune globulin G (IgG) containing antibodies to varicella zoster virus (anti-VZV). | Indicated for reducing the severity of chicken pox (varicella zoster virus) infections in high risk individuals after exposure | Provides passive immunization for nonimmune individuals exposed to varicella zoster virus, thereby reducing the severity of varicella infections | NA | Since the drug was prepared from human plasma pool, it may contain other infectious agents such as viruses and Creutzfeldt-Jakob disease (vCJD) agent. Hypersensitivity reactions such as allergic or anaphylactic reactions may occur. More common adverse effects include pain at injection site, headache, and rash. Rare adverse effects from immune globulin intravenous therapy include thrombotic events, renal dysfunction and acute renal failure, and noncardiogenic pulmonary edema. An LD50 was not determined, as the maximal dose used did not kill any experimental animals. | Immune globulins are metabolized in the reticuloendothelial system. | Intravenous administration of varicella zoster antibodies tends to persist for 6 weeks or longer. Following intramuscular administration of varicella immune globulin products, varicella antibodies are detectable within 2-3 days. The peak levels of varicella antibodies is expected to occur within 3-7 days of VariZIG administration. | Following intravenous administration of varicella zoster VZIG, anti-varicella zoster antibodies are expected to be quickly distributed between plasma and extravascular spaces with complete and immediate bioavailability. Intramuscular administration achieves nearly 100% bioavailability. | NA | Antibody | NA | NA | NA | The passive transfer of antibodies with immune globulin administration may impair the efficacy of live attenuated virus vaccines such as measles, rubella, mumps and varicella | varicella zoster virus | VARIZIG | NA | NA | It is indicated for post-exposure prophylaxis of varicella in high risk individuals. | NA | It is available in a single-use vial of 125 IU. Each 125 IU vial of VARIZIG contains less than 156 milligrams of total protein, mostly human immune globulin G (IgG). VARIZIG contains no preservative | lyophilized powder for solution | Intramuscular | Depending on patient size, divide the IM dose and administer in 2 or more injection sites; not to exceed 3 mL/injection site | Hypersensitivity to human immunoglobulins | The most common adverse drug reactions (reported by ≥ 1% of subjects) observed in clinical trials for all subjects and patients (n=601) are the following:injection site pain (3%),headache (2%),rash (including terms pruritus, rash, rash erythematous, rash vesicular and urticaria) (1%),fatigue (1%),chills (1%),nausea (1%) | Link | NA | NA |
| 11175 | Th1243 | Human immunoglobulin G | >Th1243_Human_immunoglobulin_G PSALTQPPSASGSLGQSVTISCTGTSSDVGGYNYVSWYQQHAGKAPKVIIYEVNKRPSGVPDRFSGSKSGNTASLTVSGLQAEDEADYYCSSYEGSDNFVFGTGTKVTVLGQPKANPTVTLFPPSSEELQANKATEVCLISDFYPGAVTVAWKADGSPVKAGVETTKPSKQSNNKYAASSYLSLTPEQWKSHRSYSCQVTHEGSTVEKTVAPTECSPLVLQESGPGLVKPSEALSLTCTVSGDSINTILYYWSWIRQPPGKGLEWIGYIYYSGSTYGNPSLKSRVTISVNTSKNQFYSKLSSVTAADTAVYYCARVPLVVNPWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPQPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPQVKFNWYVDGVQVHNAKTKPREQQYNSTYRVVSVLTVLHQNWLDGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSL | 142682.3 | C6332H9826N1692O1980S42 | 8.13 | -0.331 | 61 °C (FAB fragment), 71 °C (whole mAb) | >20 hours (mammalian reticulocytes, in vitro). | Intravenous immunoglobulin (IVIg) is a mixture of IgG1 and other antibodies derived from healthy human plasma via Cohn fractionation. The purification process includes cold alcohol fractionation, polyethylene glycol precipitation, and ion exchange chromatography. IVIg contains the same distribution of IgG antibody subclasses as is found in the general human population. IgG subclasses are fully represented in the following proportions: 70.3% IgG1, 24.7% IgG2, 3.1% IgG3, and 1.9% IgG4. IVIg is used in the treatment of immunodeficiencies, as well as autoimmune and inflammatory disorders. | IVIg is used in the treatment of immunodeficiencies, as well as autoimmune and inflammatory disorders. These indications includes idiopathic thrombocytopenic purpura, Kawasaki disease, hypogammaglobulinemia, B cell chronic lymphocytic leukemia, bone marrow transplant complications, Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy (CIDP), multiple sclerosis, rheumatoid arthritis, myesthenia gravis, Wiskott–Aldrich syndrome and inflammatory skin diseases. | Used as a replacement therapy in inherited humoral immunodeficiency disorders such as severe combined immunodeficiency syndrome, x-linked agammaglobulinemia, and Wiskott-Aldrich Syndrome. The immunoglobulins target, bind and kill bacterial cells as well as viral particles. IgG is the monomeric immunoglobulin of which there are four subclasses (IgG1, IgG2, IgG3 and IgG4) in differing abundances (66%, 23%, 7% and 4%). IgAs represent about 15% of the immunoglobulins in the blood. These target inhaled or ingested pathogens. | IVIg interacts with a number of different components of the immune system, including cytokines, complement, Fc receptors and several cell surface immunocompetent molecules. IVIg also impacts different effector cells of the immune system (B and T lymphocytes, dendritic cells, etc.) and regulates a wide range of genes. Its main mechanism of actions are believed to be Fc-dependent and F(ab')2-dependent. IVIg competitively blocks gamma Fc receptors, preventing the binding and ingestion of phagocytes and suppressing platelet depletion. IVIg contains a number of different antobodies, which prevent infection by attaching to the surface of invading pathogens and aiding in their disposal before they can infect cells. Antibodies remove pathogens via complement activation, agglutination or precipitation, pathogen receptor blocking, macrophage “tagging” or neutralization (via binding) of pathogen toxins. Intact IVIg and F(ab')2 fragments of IVIg can also neutralize the activity of various autoantibodies. By triggering the production of interleukin-1 receptor antagonist, IVIg modulates of the production of cytokines and cytokine antagonists. It also prevents the generation of the C5b-9 membrane attack complex and subsequent complement-mediated tissue damage by binding active complement components. | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | High affinity immunoglobulin gamma Fc receptor I,High affinity immunoglobulin gamma Fc receptor IB,Low affinity immunoglobulin gamma Fc region receptor II-a,Low affinity immunoglobulin gamma Fc region receptor II-b,Low affinity immunoglobulin gamma Fc region receptor II-c,Low affinity immunoglobulin gamma Fc region receptor III-A,Low affinity immunoglobulin gamma Fc region receptor III-B,Complement C3,Complement C4-A,Complement C4-B,Complement C5 | GamaSTAN | GRIFOLS USA, LLC | GRIFOLS USA, LLC | Intramuscular | 0.165 g/1mL | GAMASTAN is contraindicated in: Anaphylactic or severe systemic hypersensitivity reactions to immune globulin (human).11 [see WARNINGS AND PRECAUTIONS] IgA deficient patients with antibodies against IgA and a history of hypersensitivity.11 REFERENCES 11. Fudenberg HH. Sensitization to immunoglobulins and hazards of gamma globulin therapy. In: Merler E, editor. Immunoglobulins: biologic aspects and clinical uses. Washington, DC: National Academy of Sciences; 1970, p. 211-20. | local pain and tenderness at the injection site hives skin swelling allergic reactions, including anaphylaxis | Immune globulin is a sterile solution made from human plasma. It contains antibodies that protect you against infection from various diseases. Immune globulin intramuscular (IGIM, for injection into a muscle) is used to prevent infection with hepatitis A in people who travel to areas where this disease... | GamaStan is a prescription medicine used to treat the symptoms of Hepatitis A, Measles, Rubella, and Varicella. GamaStan may be used alone or with other medications. | NA | GAMASTAN is a clear or slightly opalescent, and colorless or pale yellow or light brown sterile solution of polyvalent human immune globulin for intramuscular administration. GAMASTAN contains no preservative. GAMASTAN is prepared from pools of human plasma collected from healthy donors by a combination of cold ethanol fractionation, caprylate precipitation and filtration, caprylate incubation, anion-exchange chromatography, nanofiltration and low pH incubation. GAMASTAN consists of 15% to18% protein at pH of 4.1 to 4.8 in 0.16 to 0.26 M glycine. | Link | Link | NA |
| 11176 | Th1243 | Human immunoglobulin G | >Th1243_Human_immunoglobulin_G PSALTQPPSASGSLGQSVTISCTGTSSDVGGYNYVSWYQQHAGKAPKVIIYEVNKRPSGVPDRFSGSKSGNTASLTVSGLQAEDEADYYCSSYEGSDNFVFGTGTKVTVLGQPKANPTVTLFPPSSEELQANKATEVCLISDFYPGAVTVAWKADGSPVKAGVETTKPSKQSNNKYAASSYLSLTPEQWKSHRSYSCQVTHEGSTVEKTVAPTECSPLVLQESGPGLVKPSEALSLTCTVSGDSINTILYYWSWIRQPPGKGLEWIGYIYYSGSTYGNPSLKSRVTISVNTSKNQFYSKLSSVTAADTAVYYCARVPLVVNPWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPQPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPQVKFNWYVDGVQVHNAKTKPREQQYNSTYRVVSVLTVLHQNWLDGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSL | 142682.3 | C6332H9826N1692O1980S42 | 8.13 | -0.331 | 61 °C (FAB fragment), 71 °C (whole mAb) | >20 hours (mammalian reticulocytes, in vitro). | Intravenous immunoglobulin (IVIg) is a mixture of IgG1 and other antibodies derived from healthy human plasma via Cohn fractionation. The purification process includes cold alcohol fractionation, polyethylene glycol precipitation, and ion exchange chromatography. IVIg contains the same distribution of IgG antibody subclasses as is found in the general human population. IgG subclasses are fully represented in the following proportions: 70.3% IgG1, 24.7% IgG2, 3.1% IgG3, and 1.9% IgG4. IVIg is used in the treatment of immunodeficiencies, as well as autoimmune and inflammatory disorders. | IVIg is used in the treatment of immunodeficiencies, as well as autoimmune and inflammatory disorders. These indications includes idiopathic thrombocytopenic purpura, Kawasaki disease, hypogammaglobulinemia, B cell chronic lymphocytic leukemia, bone marrow transplant complications, Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy (CIDP), multiple sclerosis, rheumatoid arthritis, myesthenia gravis, Wiskott–Aldrich syndrome and inflammatory skin diseases. | Used as a replacement therapy in inherited humoral immunodeficiency disorders such as severe combined immunodeficiency syndrome, x-linked agammaglobulinemia, and Wiskott-Aldrich Syndrome. The immunoglobulins target, bind and kill bacterial cells as well as viral particles. IgG is the monomeric immunoglobulin of which there are four subclasses (IgG1, IgG2, IgG3 and IgG4) in differing abundances (66%, 23%, 7% and 4%). IgAs represent about 15% of the immunoglobulins in the blood. These target inhaled or ingested pathogens. | IVIg interacts with a number of different components of the immune system, including cytokines, complement, Fc receptors and several cell surface immunocompetent molecules. IVIg also impacts different effector cells of the immune system (B and T lymphocytes, dendritic cells, etc.) and regulates a wide range of genes. Its main mechanism of actions are believed to be Fc-dependent and F(ab')2-dependent. IVIg competitively blocks gamma Fc receptors, preventing the binding and ingestion of phagocytes and suppressing platelet depletion. IVIg contains a number of different antobodies, which prevent infection by attaching to the surface of invading pathogens and aiding in their disposal before they can infect cells. Antibodies remove pathogens via complement activation, agglutination or precipitation, pathogen receptor blocking, macrophage “tagging” or neutralization (via binding) of pathogen toxins. Intact IVIg and F(ab')2 fragments of IVIg can also neutralize the activity of various autoantibodies. By triggering the production of interleukin-1 receptor antagonist, IVIg modulates of the production of cytokines and cytokine antagonists. It also prevents the generation of the C5b-9 membrane attack complex and subsequent complement-mediated tissue damage by binding active complement components. | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | High affinity immunoglobulin gamma Fc receptor I,High affinity immunoglobulin gamma Fc receptor IB,Low affinity immunoglobulin gamma Fc region receptor II-a,Low affinity immunoglobulin gamma Fc region receptor II-b,Low affinity immunoglobulin gamma Fc region receptor II-c,Low affinity immunoglobulin gamma Fc region receptor III-A,Low affinity immunoglobulin gamma Fc region receptor III-B,Complement C3,Complement C4-A,Complement C4-B,Complement C5 | Gamastan | Cutter Med & Biol, Division Of Miles Canada Ltd. | Cutter Med & Biol, Division Of Miles Canada Ltd. | Intramuscular | 0.165 | GAMASTAN is contraindicated in: Anaphylactic or severe systemic hypersensitivity reactions to immune globulin (human).11 [see WARNINGS AND PRECAUTIONS] IgA deficient patients with antibodies against IgA and a history of hypersensitivity.11 REFERENCES 11. Fudenberg HH. Sensitization to immunoglobulins and hazards of gamma globulin therapy. In: Merler E, editor. Immunoglobulins: biologic aspects and clinical uses. Washington, DC: National Academy of Sciences; 1970, p. 211-20. | local pain and tenderness at the injection site hives skin swelling allergic reactions, including anaphylaxis | Immune globulin is a sterile solution made from human plasma. It contains antibodies that protect you against infection from various diseases. Immune globulin intramuscular (IGIM, for injection into a muscle) is used to prevent infection with hepatitis A in people who travel to areas where this disease... | GamaStan is a prescription medicine used to treat the symptoms of Hepatitis A, Measles, Rubella, and Varicella. GamaStan may be used alone or with other medications. | NA | GAMASTAN is a clear or slightly opalescent, and colorless or pale yellow or light brown sterile solution of polyvalent human immune globulin for intramuscular administration. GAMASTAN contains no preservative. GAMASTAN is prepared from pools of human plasma collected from healthy donors by a combination of cold ethanol fractionation, caprylate precipitation and filtration, caprylate incubation, anion-exchange chromatography, nanofiltration and low pH incubation. GAMASTAN consists of 15% to18% protein at pH of 4.1 to 4.8 in 0.16 to 0.26 M glycine. | Link | Link | NA |
| 11177 | Th1243 | Human immunoglobulin G | >Th1243_Human_immunoglobulin_G PSALTQPPSASGSLGQSVTISCTGTSSDVGGYNYVSWYQQHAGKAPKVIIYEVNKRPSGVPDRFSGSKSGNTASLTVSGLQAEDEADYYCSSYEGSDNFVFGTGTKVTVLGQPKANPTVTLFPPSSEELQANKATEVCLISDFYPGAVTVAWKADGSPVKAGVETTKPSKQSNNKYAASSYLSLTPEQWKSHRSYSCQVTHEGSTVEKTVAPTECSPLVLQESGPGLVKPSEALSLTCTVSGDSINTILYYWSWIRQPPGKGLEWIGYIYYSGSTYGNPSLKSRVTISVNTSKNQFYSKLSSVTAADTAVYYCARVPLVVNPWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPQPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPQVKFNWYVDGVQVHNAKTKPREQQYNSTYRVVSVLTVLHQNWLDGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSL | 142682.3 | C6332H9826N1692O1980S42 | 8.13 | -0.331 | 61 °C (FAB fragment), 71 °C (whole mAb) | >20 hours (mammalian reticulocytes, in vitro). | Intravenous immunoglobulin (IVIg) is a mixture of IgG1 and other antibodies derived from healthy human plasma via Cohn fractionation. The purification process includes cold alcohol fractionation, polyethylene glycol precipitation, and ion exchange chromatography. IVIg contains the same distribution of IgG antibody subclasses as is found in the general human population. IgG subclasses are fully represented in the following proportions: 70.3% IgG1, 24.7% IgG2, 3.1% IgG3, and 1.9% IgG4. IVIg is used in the treatment of immunodeficiencies, as well as autoimmune and inflammatory disorders. | IVIg is used in the treatment of immunodeficiencies, as well as autoimmune and inflammatory disorders. These indications includes idiopathic thrombocytopenic purpura, Kawasaki disease, hypogammaglobulinemia, B cell chronic lymphocytic leukemia, bone marrow transplant complications, Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy (CIDP), multiple sclerosis, rheumatoid arthritis, myesthenia gravis, Wiskott–Aldrich syndrome and inflammatory skin diseases. | Used as a replacement therapy in inherited humoral immunodeficiency disorders such as severe combined immunodeficiency syndrome, x-linked agammaglobulinemia, and Wiskott-Aldrich Syndrome. The immunoglobulins target, bind and kill bacterial cells as well as viral particles. IgG is the monomeric immunoglobulin of which there are four subclasses (IgG1, IgG2, IgG3 and IgG4) in differing abundances (66%, 23%, 7% and 4%). IgAs represent about 15% of the immunoglobulins in the blood. These target inhaled or ingested pathogens. | IVIg interacts with a number of different components of the immune system, including cytokines, complement, Fc receptors and several cell surface immunocompetent molecules. IVIg also impacts different effector cells of the immune system (B and T lymphocytes, dendritic cells, etc.) and regulates a wide range of genes. Its main mechanism of actions are believed to be Fc-dependent and F(ab')2-dependent. IVIg competitively blocks gamma Fc receptors, preventing the binding and ingestion of phagocytes and suppressing platelet depletion. IVIg contains a number of different antobodies, which prevent infection by attaching to the surface of invading pathogens and aiding in their disposal before they can infect cells. Antibodies remove pathogens via complement activation, agglutination or precipitation, pathogen receptor blocking, macrophage “tagging” or neutralization (via binding) of pathogen toxins. Intact IVIg and F(ab')2 fragments of IVIg can also neutralize the activity of various autoantibodies. By triggering the production of interleukin-1 receptor antagonist, IVIg modulates of the production of cytokines and cytokine antagonists. It also prevents the generation of the C5b-9 membrane attack complex and subsequent complement-mediated tissue damage by binding active complement components. | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | High affinity immunoglobulin gamma Fc receptor I,High affinity immunoglobulin gamma Fc receptor IB,Low affinity immunoglobulin gamma Fc region receptor II-a,Low affinity immunoglobulin gamma Fc region receptor II-b,Low affinity immunoglobulin gamma Fc region receptor II-c,Low affinity immunoglobulin gamma Fc region receptor III-A,Low affinity immunoglobulin gamma Fc region receptor III-B,Complement C3,Complement C4-A,Complement C4-B,Complement C5 | Gamastan | Grifols Therapeutics Llc | Grifols Therapeutics Llc | Intramuscular | 0.18 | GAMASTAN is contraindicated in: Anaphylactic or severe systemic hypersensitivity reactions to immune globulin (human).11 [see WARNINGS AND PRECAUTIONS] IgA deficient patients with antibodies against IgA and a history of hypersensitivity.11 REFERENCES 11. Fudenberg HH. Sensitization to immunoglobulins and hazards of gamma globulin therapy. In: Merler E, editor. Immunoglobulins: biologic aspects and clinical uses. Washington, DC: National Academy of Sciences; 1970, p. 211-20. | local pain and tenderness at the injection site hives skin swelling allergic reactions, including anaphylaxis | Immune globulin is a sterile solution made from human plasma. It contains antibodies that protect you against infection from various diseases. Immune globulin intramuscular (IGIM, for injection into a muscle) is used to prevent infection with hepatitis A in people who travel to areas where this disease... | GamaStan is a prescription medicine used to treat the symptoms of Hepatitis A, Measles, Rubella, and Varicella. GamaStan may be used alone or with other medications. | NA | GAMASTAN is a clear or slightly opalescent, and colorless or pale yellow or light brown sterile solution of polyvalent human immune globulin for intramuscular administration. GAMASTAN contains no preservative. GAMASTAN is prepared from pools of human plasma collected from healthy donors by a combination of cold ethanol fractionation, caprylate precipitation and filtration, caprylate incubation, anion-exchange chromatography, nanofiltration and low pH incubation. GAMASTAN consists of 15% to18% protein at pH of 4.1 to 4.8 in 0.16 to 0.26 M glycine. | Link | Link | NA |
| 11425 | Th1247 | Glucagon | >Th1247_Glucagon HSQGTFTSDYSKYLDSRRAQDFVQWLMNT | 3767.1 | C165H249N49O51S1 | 7.1 | NA | NA | The half life of glucagon is 26 minutes for an intramuscular dose.[L7634] The half life of glucagon nasal powder is approximately 35 minutes.[L7643] The half life of glucagon by a subcutaneous auto-injector or pre-filled syringe is 32 minutes.[L8519] | Glucagon is a 29 amino acid hormone used as a diagnostic aid in radiologic exams to temporarily inhibit the movement of the gastrointestinal tract and to treat severe hypoglycemia.[L7634,L7637,L7640,L7643,L8519] Glucagon raises blood sugar through activation of hepatic glucagon receptors, stimulating glycogenolysis and the release of glucose.[L7640,L7643] Glucagon was granted FDA approval on 14 November 1960.[L7631] | Glucagon is indicated as a diagnostic aid in radiologic exams to temporarily inhibit the movement of the gastrointestinal tract and to treat severe hypoglycemia.[L7634,L7637,L7640,L7643,L8519] | Glucagon is indicated as a diagnostic aid in radiologic exams to temporarily inhibit the movement of the gastrointestinal tract and severe hypoglycemia.[A19402,L7634,L7637,L7640,L7643,L8519] Glucagon raises blood sugar through activation of hepatic glucagon receptors, stimulating glycogenolysis and the release of glucose.[L7640,L7643] Glucagon has a short duration of action.[L7634,L7637,L7640,L7643] Glucagon may cause hyperglycemia in diabetic patients.[L7634,L7637,L7640,L7643] | Glucagon binds to the glucagon receptor activating Gsa and Gq.[A19402] This activation activates adenylate cyclase, which increases intracellular cyclic AMP and activates protein kinase A.[A19402] Activating Gq activates phospholipase C, increases production of inositol 1,4,5-triphosphate, and releases intracellular calcium.[A19402] Protein kinase A phosphorylates glycogen phosphorylase kinase, which phosphorylates glycogen phosphorylase, which phosphorylates glycogen, causing its breakdown.[A19402] Glucagon also relaxes smooth muscle of the stomach, duodenum, small bowel, and colon.[L7634,L7643] | Patients experiencing an overdose may present with nausea, vomiting, inhibition of GI tract motility, increased blood pressure and heart rate, and decreased serum potassium.[L7634,L7637,L7640,L7643] Phentolamine may be given to control blood pressure.[L7634,L7637,L7640,L7643] Treatment of glucagon overdose is largely symptomatic for nausea, vomiting, and hypokalemia.[L7637] The LD50 for intravenous glucagon in mice is 300mg/kg and in rats is 38.6mg/kg.[L7637] | Glucagon is a protein and so it is metabolized into smaller polypeptides and amino acids in the liver, kidney, and plasma.[L7634,L7643] | A 1mg intravenous dose of glucagon reaches a Cmax of 7.9ng/mL with a Tmax of 20 minutes.[L7637] An intramuscular dose reaches a Cmax of 6.9ng/mL with a Tmax of 13 minutes.[L7637] A 3mg dose of glucagon nasal powder reaches a Cmax of 6130pg/mL with a Tmax of 15 minutes.[L7643] | The volume of distribution of glucagon is 0.25L/kg.[L7637] The apparent volume of distribution is 885L.[L7643] | A 1mg intravenous dose of glucagon has a clearance of 13.5mL/min/kg.[L7637] | Proteins | NA | NA | NA | NA | Glucagon receptor,Glucagon-like peptide 2 receptor,Glucagon-like peptide 1 receptor | Gvoke HypoPen 0.5 mg Auto-Injector | Xeris Pharmaceuticals, Inc. | Xeris Pharmaceuticals, Inc. | Subcutaneous | 0.5 mg/0.1mL | GVOKE is contraindicated in patients with: Pheochromocytoma Insulinoma [ see WARNINGS AND PRECAUTIONS] because of the risk of hypoglycemia Known hypersensitivity to glucagon or to any of the excipients in GVOKE. Allergic reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension. | nausea vomiting hives injection site swelling or redness headache fast heartbeat | Glucagon comes as a solution (liquid) in a prefilled syringe and an auto-injector device to inject subcutaneously (just under the skin). It also comes as a powder to be mixed with a provided liquid to be injected subcutaneously, intramuscularly (into the muscle), or intravenously (into a vein). It is usually injected as needed at the first sign of severe hypoglycemia. | Glucagon is used along with emergency medical treatment to treat very low blood sugar. Glucagon is also used in diagnostic testing of the stomach and other digestive organs. Glucagon is in a class of medications called glycogenolytic agents. It works by causing the liver to release stored sugar to the blood. It also works by relaxing smooth muscles of the stomach and other digestive organs for diagnostic testing. | (3S)-3-[[(2S)-5-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-6-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S,3R)-2-[[(2S)-2-[[(2S,3R)-2-[[2-[[(2S)-5-amino-2-[[(2S)-2-[[(2S)-2-amino-3-(1H-imidazol-5-yl)propanoyl]amino]-3-hydroxypropanoyl]amino]-5-oxopentanoyl]amino]acetyl]amino]-3-hydroxybutanoyl]amino]-3-phenylpropanoyl]amino]-3-hydroxybutanoyl]amino]-3-hydroxypropanoyl]amino]-3-carboxypropanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-3-hydroxypropanoyl]amino]hexanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-4-methylpentanoyl]amino]-3-carboxypropanoyl]amino]-3-hydroxypropanoyl]amino]-5-carbamimidamidopentanoyl]amino]-5-carbamimidamidopentanoyl]amino]propanoyl]amino]-5-oxopentanoyl]amino]-4-[[(2S)-1-[[(2S)-1-[[(2S)-5-amino-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-4-amino-1-[[(1S,2R)-1-carboxy-2-hydroxypropyl]amino]-1,4-dioxobutan-2-yl]amino]-4-methylsulfanyl-1-oxobutan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-3-(1H-indol-3-yl)-1-oxopropan-2-yl]amino]-1,5-dioxopentan-2-yl]amino]-3-methyl-1-oxobutan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]amino]-4-oxobutanoic acid | NA | Link | Link | NA |
| 11426 | Th1247 | Glucagon | >Th1247_Glucagon HSQGTFTSDYSKYLDSRRAQDFVQWLMNT | 3767.1 | C165H249N49O51S1 | 7.1 | NA | NA | The half life of glucagon is 26 minutes for an intramuscular dose.[L7634] The half life of glucagon nasal powder is approximately 35 minutes.[L7643] The half life of glucagon by a subcutaneous auto-injector or pre-filled syringe is 32 minutes.[L8519] | Glucagon is a 29 amino acid hormone used as a diagnostic aid in radiologic exams to temporarily inhibit the movement of the gastrointestinal tract and to treat severe hypoglycemia.[L7634,L7637,L7640,L7643,L8519] Glucagon raises blood sugar through activation of hepatic glucagon receptors, stimulating glycogenolysis and the release of glucose.[L7640,L7643] Glucagon was granted FDA approval on 14 November 1960.[L7631] | Glucagon is indicated as a diagnostic aid in radiologic exams to temporarily inhibit the movement of the gastrointestinal tract and to treat severe hypoglycemia.[L7634,L7637,L7640,L7643,L8519] | Glucagon is indicated as a diagnostic aid in radiologic exams to temporarily inhibit the movement of the gastrointestinal tract and severe hypoglycemia.[A19402,L7634,L7637,L7640,L7643,L8519] Glucagon raises blood sugar through activation of hepatic glucagon receptors, stimulating glycogenolysis and the release of glucose.[L7640,L7643] Glucagon has a short duration of action.[L7634,L7637,L7640,L7643] Glucagon may cause hyperglycemia in diabetic patients.[L7634,L7637,L7640,L7643] | Glucagon binds to the glucagon receptor activating Gsa and Gq.[A19402] This activation activates adenylate cyclase, which increases intracellular cyclic AMP and activates protein kinase A.[A19402] Activating Gq activates phospholipase C, increases production of inositol 1,4,5-triphosphate, and releases intracellular calcium.[A19402] Protein kinase A phosphorylates glycogen phosphorylase kinase, which phosphorylates glycogen phosphorylase, which phosphorylates glycogen, causing its breakdown.[A19402] Glucagon also relaxes smooth muscle of the stomach, duodenum, small bowel, and colon.[L7634,L7643] | Patients experiencing an overdose may present with nausea, vomiting, inhibition of GI tract motility, increased blood pressure and heart rate, and decreased serum potassium.[L7634,L7637,L7640,L7643] Phentolamine may be given to control blood pressure.[L7634,L7637,L7640,L7643] Treatment of glucagon overdose is largely symptomatic for nausea, vomiting, and hypokalemia.[L7637] The LD50 for intravenous glucagon in mice is 300mg/kg and in rats is 38.6mg/kg.[L7637] | Glucagon is a protein and so it is metabolized into smaller polypeptides and amino acids in the liver, kidney, and plasma.[L7634,L7643] | A 1mg intravenous dose of glucagon reaches a Cmax of 7.9ng/mL with a Tmax of 20 minutes.[L7637] An intramuscular dose reaches a Cmax of 6.9ng/mL with a Tmax of 13 minutes.[L7637] A 3mg dose of glucagon nasal powder reaches a Cmax of 6130pg/mL with a Tmax of 15 minutes.[L7643] | The volume of distribution of glucagon is 0.25L/kg.[L7637] The apparent volume of distribution is 885L.[L7643] | A 1mg intravenous dose of glucagon has a clearance of 13.5mL/min/kg.[L7637] | Systemic Hormonal Preparations, Excl. Sex Hormones and Insulins | NA | NA | NA | NA | Glucagon receptor,Glucagon-like peptide 2 receptor,Glucagon-like peptide 1 receptor | Gvoke HypoPen 1 mg Auto-Injector | Xeris Pharmaceuticals, Inc. | Xeris Pharmaceuticals, Inc. | Subcutaneous | 1 mg/0.2mL | GVOKE is contraindicated in patients with: Pheochromocytoma Insulinoma [ see WARNINGS AND PRECAUTIONS] because of the risk of hypoglycemia Known hypersensitivity to glucagon or to any of the excipients in GVOKE. Allergic reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension. | nausea vomiting hives injection site swelling or redness headache fast heartbeat | Glucagon comes as a solution (liquid) in a prefilled syringe and an auto-injector device to inject subcutaneously (just under the skin). It also comes as a powder to be mixed with a provided liquid to be injected subcutaneously, intramuscularly (into the muscle), or intravenously (into a vein). It is usually injected as needed at the first sign of severe hypoglycemia. | Glucagon is used along with emergency medical treatment to treat very low blood sugar. Glucagon is also used in diagnostic testing of the stomach and other digestive organs. Glucagon is in a class of medications called glycogenolytic agents. It works by causing the liver to release stored sugar to the blood. It also works by relaxing smooth muscles of the stomach and other digestive organs for diagnostic testing. | (3S)-3-[[(2S)-5-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-6-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S,3R)-2-[[(2S)-2-[[(2S,3R)-2-[[2-[[(2S)-5-amino-2-[[(2S)-2-[[(2S)-2-amino-3-(1H-imidazol-5-yl)propanoyl]amino]-3-hydroxypropanoyl]amino]-5-oxopentanoyl]amino]acetyl]amino]-3-hydroxybutanoyl]amino]-3-phenylpropanoyl]amino]-3-hydroxybutanoyl]amino]-3-hydroxypropanoyl]amino]-3-carboxypropanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-3-hydroxypropanoyl]amino]hexanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-4-methylpentanoyl]amino]-3-carboxypropanoyl]amino]-3-hydroxypropanoyl]amino]-5-carbamimidamidopentanoyl]amino]-5-carbamimidamidopentanoyl]amino]propanoyl]amino]-5-oxopentanoyl]amino]-4-[[(2S)-1-[[(2S)-1-[[(2S)-5-amino-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-4-amino-1-[[(1S,2R)-1-carboxy-2-hydroxypropyl]amino]-1,4-dioxobutan-2-yl]amino]-4-methylsulfanyl-1-oxobutan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-3-(1H-indol-3-yl)-1-oxopropan-2-yl]amino]-1,5-dioxopentan-2-yl]amino]-3-methyl-1-oxobutan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]amino]-4-oxobutanoic acid | NA | Link | Link | NA |
| 11427 | Th1247 | Glucagon | >Th1247_Glucagon HSQGTFTSDYSKYLDSRRAQDFVQWLMNT | 3767.1 | C165H249N49O51S1 | 7.1 | NA | NA | The half life of glucagon is 26 minutes for an intramuscular dose.[L7634] The half life of glucagon nasal powder is approximately 35 minutes.[L7643] The half life of glucagon by a subcutaneous auto-injector or pre-filled syringe is 32 minutes.[L8519] | Glucagon is a 29 amino acid hormone used as a diagnostic aid in radiologic exams to temporarily inhibit the movement of the gastrointestinal tract and to treat severe hypoglycemia.[L7634,L7637,L7640,L7643,L8519] Glucagon raises blood sugar through activation of hepatic glucagon receptors, stimulating glycogenolysis and the release of glucose.[L7640,L7643] Glucagon was granted FDA approval on 14 November 1960.[L7631] | Glucagon is indicated as a diagnostic aid in radiologic exams to temporarily inhibit the movement of the gastrointestinal tract and to treat severe hypoglycemia.[L7634,L7637,L7640,L7643,L8519] | Glucagon is indicated as a diagnostic aid in radiologic exams to temporarily inhibit the movement of the gastrointestinal tract and severe hypoglycemia.[A19402,L7634,L7637,L7640,L7643,L8519] Glucagon raises blood sugar through activation of hepatic glucagon receptors, stimulating glycogenolysis and the release of glucose.[L7640,L7643] Glucagon has a short duration of action.[L7634,L7637,L7640,L7643] Glucagon may cause hyperglycemia in diabetic patients.[L7634,L7637,L7640,L7643] | Glucagon binds to the glucagon receptor activating Gsa and Gq.[A19402] This activation activates adenylate cyclase, which increases intracellular cyclic AMP and activates protein kinase A.[A19402] Activating Gq activates phospholipase C, increases production of inositol 1,4,5-triphosphate, and releases intracellular calcium.[A19402] Protein kinase A phosphorylates glycogen phosphorylase kinase, which phosphorylates glycogen phosphorylase, which phosphorylates glycogen, causing its breakdown.[A19402] Glucagon also relaxes smooth muscle of the stomach, duodenum, small bowel, and colon.[L7634,L7643] | Patients experiencing an overdose may present with nausea, vomiting, inhibition of GI tract motility, increased blood pressure and heart rate, and decreased serum potassium.[L7634,L7637,L7640,L7643] Phentolamine may be given to control blood pressure.[L7634,L7637,L7640,L7643] Treatment of glucagon overdose is largely symptomatic for nausea, vomiting, and hypokalemia.[L7637] The LD50 for intravenous glucagon in mice is 300mg/kg and in rats is 38.6mg/kg.[L7637] | Glucagon is a protein and so it is metabolized into smaller polypeptides and amino acids in the liver, kidney, and plasma.[L7634,L7643] | A 1mg intravenous dose of glucagon reaches a Cmax of 7.9ng/mL with a Tmax of 20 minutes.[L7637] An intramuscular dose reaches a Cmax of 6.9ng/mL with a Tmax of 13 minutes.[L7637] A 3mg dose of glucagon nasal powder reaches a Cmax of 6130pg/mL with a Tmax of 15 minutes.[L7643] | The volume of distribution of glucagon is 0.25L/kg.[L7637] The apparent volume of distribution is 885L.[L7643] | A 1mg intravenous dose of glucagon has a clearance of 13.5mL/min/kg.[L7637] | NA | NA | NA | NA | NA | Glucagon receptor,Glucagon-like peptide 2 receptor,Glucagon-like peptide 1 receptor | Gvoke Kit | Xeris Pharmaceuticals, Inc. | Xeris Pharmaceuticals, Inc. | Subcutaneous | 1 mg/0.2mL | GVOKE is contraindicated in patients with: Pheochromocytoma Insulinoma [ see WARNINGS AND PRECAUTIONS] because of the risk of hypoglycemia Known hypersensitivity to glucagon or to any of the excipients in GVOKE. Allergic reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension. | nausea vomiting hives injection site swelling or redness headache fast heartbeat | Glucagon comes as a solution (liquid) in a prefilled syringe and an auto-injector device to inject subcutaneously (just under the skin). It also comes as a powder to be mixed with a provided liquid to be injected subcutaneously, intramuscularly (into the muscle), or intravenously (into a vein). It is usually injected as needed at the first sign of severe hypoglycemia. | Glucagon is used along with emergency medical treatment to treat very low blood sugar. Glucagon is also used in diagnostic testing of the stomach and other digestive organs. Glucagon is in a class of medications called glycogenolytic agents. It works by causing the liver to release stored sugar to the blood. It also works by relaxing smooth muscles of the stomach and other digestive organs for diagnostic testing. | (3S)-3-[[(2S)-5-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-6-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S,3R)-2-[[(2S)-2-[[(2S,3R)-2-[[2-[[(2S)-5-amino-2-[[(2S)-2-[[(2S)-2-amino-3-(1H-imidazol-5-yl)propanoyl]amino]-3-hydroxypropanoyl]amino]-5-oxopentanoyl]amino]acetyl]amino]-3-hydroxybutanoyl]amino]-3-phenylpropanoyl]amino]-3-hydroxybutanoyl]amino]-3-hydroxypropanoyl]amino]-3-carboxypropanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-3-hydroxypropanoyl]amino]hexanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-4-methylpentanoyl]amino]-3-carboxypropanoyl]amino]-3-hydroxypropanoyl]amino]-5-carbamimidamidopentanoyl]amino]-5-carbamimidamidopentanoyl]amino]propanoyl]amino]-5-oxopentanoyl]amino]-4-[[(2S)-1-[[(2S)-1-[[(2S)-5-amino-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-4-amino-1-[[(1S,2R)-1-carboxy-2-hydroxypropyl]amino]-1,4-dioxobutan-2-yl]amino]-4-methylsulfanyl-1-oxobutan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-3-(1H-indol-3-yl)-1-oxopropan-2-yl]amino]-1,5-dioxopentan-2-yl]amino]-3-methyl-1-oxobutan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]amino]-4-oxobutanoic acid | NA | Link | Link | NA |
| 11428 | Th1247 | Glucagon | >Th1247_Glucagon HSQGTFTSDYSKYLDSRRAQDFVQWLMNT | 3767.1 | C165H249N49O51S1 | 7.1 | NA | NA | The half life of glucagon is 26 minutes for an intramuscular dose.[L7634] The half life of glucagon nasal powder is approximately 35 minutes.[L7643] The half life of glucagon by a subcutaneous auto-injector or pre-filled syringe is 32 minutes.[L8519] | Glucagon is a 29 amino acid hormone used as a diagnostic aid in radiologic exams to temporarily inhibit the movement of the gastrointestinal tract and to treat severe hypoglycemia.[L7634,L7637,L7640,L7643,L8519] Glucagon raises blood sugar through activation of hepatic glucagon receptors, stimulating glycogenolysis and the release of glucose.[L7640,L7643] Glucagon was granted FDA approval on 14 November 1960.[L7631] | Glucagon is indicated as a diagnostic aid in radiologic exams to temporarily inhibit the movement of the gastrointestinal tract and to treat severe hypoglycemia.[L7634,L7637,L7640,L7643,L8519] | Glucagon is indicated as a diagnostic aid in radiologic exams to temporarily inhibit the movement of the gastrointestinal tract and severe hypoglycemia.[A19402,L7634,L7637,L7640,L7643,L8519] Glucagon raises blood sugar through activation of hepatic glucagon receptors, stimulating glycogenolysis and the release of glucose.[L7640,L7643] Glucagon has a short duration of action.[L7634,L7637,L7640,L7643] Glucagon may cause hyperglycemia in diabetic patients.[L7634,L7637,L7640,L7643] | Glucagon binds to the glucagon receptor activating Gsa and Gq.[A19402] This activation activates adenylate cyclase, which increases intracellular cyclic AMP and activates protein kinase A.[A19402] Activating Gq activates phospholipase C, increases production of inositol 1,4,5-triphosphate, and releases intracellular calcium.[A19402] Protein kinase A phosphorylates glycogen phosphorylase kinase, which phosphorylates glycogen phosphorylase, which phosphorylates glycogen, causing its breakdown.[A19402] Glucagon also relaxes smooth muscle of the stomach, duodenum, small bowel, and colon.[L7634,L7643] | Patients experiencing an overdose may present with nausea, vomiting, inhibition of GI tract motility, increased blood pressure and heart rate, and decreased serum potassium.[L7634,L7637,L7640,L7643] Phentolamine may be given to control blood pressure.[L7634,L7637,L7640,L7643] Treatment of glucagon overdose is largely symptomatic for nausea, vomiting, and hypokalemia.[L7637] The LD50 for intravenous glucagon in mice is 300mg/kg and in rats is 38.6mg/kg.[L7637] | Glucagon is a protein and so it is metabolized into smaller polypeptides and amino acids in the liver, kidney, and plasma.[L7634,L7643] | A 1mg intravenous dose of glucagon reaches a Cmax of 7.9ng/mL with a Tmax of 20 minutes.[L7637] An intramuscular dose reaches a Cmax of 6.9ng/mL with a Tmax of 13 minutes.[L7637] A 3mg dose of glucagon nasal powder reaches a Cmax of 6130pg/mL with a Tmax of 15 minutes.[L7643] | The volume of distribution of glucagon is 0.25L/kg.[L7637] The apparent volume of distribution is 885L.[L7643] | A 1mg intravenous dose of glucagon has a clearance of 13.5mL/min/kg.[L7637] | NA | NA | NA | NA | NA | Glucagon receptor,Glucagon-like peptide 2 receptor,Glucagon-like peptide 1 receptor | Gvoke Kit Vial | Xeris Pharmaceuticals, Inc. | Xeris Pharmaceuticals, Inc. | Subcutaneous | 1 mg/0.2mL | GVOKE is contraindicated in patients with: Pheochromocytoma Insulinoma [ see WARNINGS AND PRECAUTIONS] because of the risk of hypoglycemia Known hypersensitivity to glucagon or to any of the excipients in GVOKE. Allergic reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension. | nausea vomiting hives injection site swelling or redness headache fast heartbeat | Glucagon comes as a solution (liquid) in a prefilled syringe and an auto-injector device to inject subcutaneously (just under the skin). It also comes as a powder to be mixed with a provided liquid to be injected subcutaneously, intramuscularly (into the muscle), or intravenously (into a vein). It is usually injected as needed at the first sign of severe hypoglycemia. | Glucagon is used along with emergency medical treatment to treat very low blood sugar. Glucagon is also used in diagnostic testing of the stomach and other digestive organs. Glucagon is in a class of medications called glycogenolytic agents. It works by causing the liver to release stored sugar to the blood. It also works by relaxing smooth muscles of the stomach and other digestive organs for diagnostic testing. | (3S)-3-[[(2S)-5-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-6-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S,3R)-2-[[(2S)-2-[[(2S,3R)-2-[[2-[[(2S)-5-amino-2-[[(2S)-2-[[(2S)-2-amino-3-(1H-imidazol-5-yl)propanoyl]amino]-3-hydroxypropanoyl]amino]-5-oxopentanoyl]amino]acetyl]amino]-3-hydroxybutanoyl]amino]-3-phenylpropanoyl]amino]-3-hydroxybutanoyl]amino]-3-hydroxypropanoyl]amino]-3-carboxypropanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-3-hydroxypropanoyl]amino]hexanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-4-methylpentanoyl]amino]-3-carboxypropanoyl]amino]-3-hydroxypropanoyl]amino]-5-carbamimidamidopentanoyl]amino]-5-carbamimidamidopentanoyl]amino]propanoyl]amino]-5-oxopentanoyl]amino]-4-[[(2S)-1-[[(2S)-1-[[(2S)-5-amino-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-4-amino-1-[[(1S,2R)-1-carboxy-2-hydroxypropyl]amino]-1,4-dioxobutan-2-yl]amino]-4-methylsulfanyl-1-oxobutan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-3-(1H-indol-3-yl)-1-oxopropan-2-yl]amino]-1,5-dioxopentan-2-yl]amino]-3-methyl-1-oxobutan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]amino]-4-oxobutanoic acid | NA | Link | Link | NA |
| 11429 | Th1247 | Glucagon | >Th1247_Glucagon HSQGTFTSDYSKYLDSRRAQDFVQWLMNT | 3767.1 | C165H249N49O51S1 | 7.1 | NA | NA | The half life of glucagon is 26 minutes for an intramuscular dose.[L7634] The half life of glucagon nasal powder is approximately 35 minutes.[L7643] The half life of glucagon by a subcutaneous auto-injector or pre-filled syringe is 32 minutes.[L8519] | Glucagon is a 29 amino acid hormone used as a diagnostic aid in radiologic exams to temporarily inhibit the movement of the gastrointestinal tract and to treat severe hypoglycemia.[L7634,L7637,L7640,L7643,L8519] Glucagon raises blood sugar through activation of hepatic glucagon receptors, stimulating glycogenolysis and the release of glucose.[L7640,L7643] Glucagon was granted FDA approval on 14 November 1960.[L7631] | Glucagon is indicated as a diagnostic aid in radiologic exams to temporarily inhibit the movement of the gastrointestinal tract and to treat severe hypoglycemia.[L7634,L7637,L7640,L7643,L8519] | Glucagon is indicated as a diagnostic aid in radiologic exams to temporarily inhibit the movement of the gastrointestinal tract and severe hypoglycemia.[A19402,L7634,L7637,L7640,L7643,L8519] Glucagon raises blood sugar through activation of hepatic glucagon receptors, stimulating glycogenolysis and the release of glucose.[L7640,L7643] Glucagon has a short duration of action.[L7634,L7637,L7640,L7643] Glucagon may cause hyperglycemia in diabetic patients.[L7634,L7637,L7640,L7643] | Glucagon binds to the glucagon receptor activating Gsa and Gq.[A19402] This activation activates adenylate cyclase, which increases intracellular cyclic AMP and activates protein kinase A.[A19402] Activating Gq activates phospholipase C, increases production of inositol 1,4,5-triphosphate, and releases intracellular calcium.[A19402] Protein kinase A phosphorylates glycogen phosphorylase kinase, which phosphorylates glycogen phosphorylase, which phosphorylates glycogen, causing its breakdown.[A19402] Glucagon also relaxes smooth muscle of the stomach, duodenum, small bowel, and colon.[L7634,L7643] | Patients experiencing an overdose may present with nausea, vomiting, inhibition of GI tract motility, increased blood pressure and heart rate, and decreased serum potassium.[L7634,L7637,L7640,L7643] Phentolamine may be given to control blood pressure.[L7634,L7637,L7640,L7643] Treatment of glucagon overdose is largely symptomatic for nausea, vomiting, and hypokalemia.[L7637] The LD50 for intravenous glucagon in mice is 300mg/kg and in rats is 38.6mg/kg.[L7637] | Glucagon is a protein and so it is metabolized into smaller polypeptides and amino acids in the liver, kidney, and plasma.[L7634,L7643] | A 1mg intravenous dose of glucagon reaches a Cmax of 7.9ng/mL with a Tmax of 20 minutes.[L7637] An intramuscular dose reaches a Cmax of 6.9ng/mL with a Tmax of 13 minutes.[L7637] A 3mg dose of glucagon nasal powder reaches a Cmax of 6130pg/mL with a Tmax of 15 minutes.[L7643] | The volume of distribution of glucagon is 0.25L/kg.[L7637] The apparent volume of distribution is 885L.[L7643] | A 1mg intravenous dose of glucagon has a clearance of 13.5mL/min/kg.[L7637] | NA | NA | NA | NA | NA | Glucagon receptor,Glucagon-like peptide 2 receptor,Glucagon-like peptide 1 receptor | Gvoke PFS 0.5 mg Pre-filled Syringe | Xeris Pharmaceuticals, Inc. | Xeris Pharmaceuticals, Inc. | Subcutaneous | 0.5 mg/0.1mL | GVOKE is contraindicated in patients with: Pheochromocytoma Insulinoma [ see WARNINGS AND PRECAUTIONS] because of the risk of hypoglycemia Known hypersensitivity to glucagon or to any of the excipients in GVOKE. Allergic reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension. | nausea vomiting hives injection site swelling or redness headache fast heartbeat | Glucagon comes as a solution (liquid) in a prefilled syringe and an auto-injector device to inject subcutaneously (just under the skin). It also comes as a powder to be mixed with a provided liquid to be injected subcutaneously, intramuscularly (into the muscle), or intravenously (into a vein). It is usually injected as needed at the first sign of severe hypoglycemia. | Glucagon is used along with emergency medical treatment to treat very low blood sugar. Glucagon is also used in diagnostic testing of the stomach and other digestive organs. Glucagon is in a class of medications called glycogenolytic agents. It works by causing the liver to release stored sugar to the blood. It also works by relaxing smooth muscles of the stomach and other digestive organs for diagnostic testing. | (3S)-3-[[(2S)-5-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-6-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S,3R)-2-[[(2S)-2-[[(2S,3R)-2-[[2-[[(2S)-5-amino-2-[[(2S)-2-[[(2S)-2-amino-3-(1H-imidazol-5-yl)propanoyl]amino]-3-hydroxypropanoyl]amino]-5-oxopentanoyl]amino]acetyl]amino]-3-hydroxybutanoyl]amino]-3-phenylpropanoyl]amino]-3-hydroxybutanoyl]amino]-3-hydroxypropanoyl]amino]-3-carboxypropanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-3-hydroxypropanoyl]amino]hexanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-4-methylpentanoyl]amino]-3-carboxypropanoyl]amino]-3-hydroxypropanoyl]amino]-5-carbamimidamidopentanoyl]amino]-5-carbamimidamidopentanoyl]amino]propanoyl]amino]-5-oxopentanoyl]amino]-4-[[(2S)-1-[[(2S)-1-[[(2S)-5-amino-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-4-amino-1-[[(1S,2R)-1-carboxy-2-hydroxypropyl]amino]-1,4-dioxobutan-2-yl]amino]-4-methylsulfanyl-1-oxobutan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-3-(1H-indol-3-yl)-1-oxopropan-2-yl]amino]-1,5-dioxopentan-2-yl]amino]-3-methyl-1-oxobutan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]amino]-4-oxobutanoic acid | NA | Link | Link | NA |
| 11430 | Th1247 | Glucagon | >Th1247_Glucagon HSQGTFTSDYSKYLDSRRAQDFVQWLMNT | 3767.1 | C165H249N49O51S1 | 7.1 | NA | NA | The half life of glucagon is 26 minutes for an intramuscular dose.[L7634] The half life of glucagon nasal powder is approximately 35 minutes.[L7643] The half life of glucagon by a subcutaneous auto-injector or pre-filled syringe is 32 minutes.[L8519] | Glucagon is a 29 amino acid hormone used as a diagnostic aid in radiologic exams to temporarily inhibit the movement of the gastrointestinal tract and to treat severe hypoglycemia.[L7634,L7637,L7640,L7643,L8519] Glucagon raises blood sugar through activation of hepatic glucagon receptors, stimulating glycogenolysis and the release of glucose.[L7640,L7643] Glucagon was granted FDA approval on 14 November 1960.[L7631] | Glucagon is indicated as a diagnostic aid in radiologic exams to temporarily inhibit the movement of the gastrointestinal tract and to treat severe hypoglycemia.[L7634,L7637,L7640,L7643,L8519] | Glucagon is indicated as a diagnostic aid in radiologic exams to temporarily inhibit the movement of the gastrointestinal tract and severe hypoglycemia.[A19402,L7634,L7637,L7640,L7643,L8519] Glucagon raises blood sugar through activation of hepatic glucagon receptors, stimulating glycogenolysis and the release of glucose.[L7640,L7643] Glucagon has a short duration of action.[L7634,L7637,L7640,L7643] Glucagon may cause hyperglycemia in diabetic patients.[L7634,L7637,L7640,L7643] | Glucagon binds to the glucagon receptor activating Gsa and Gq.[A19402] This activation activates adenylate cyclase, which increases intracellular cyclic AMP and activates protein kinase A.[A19402] Activating Gq activates phospholipase C, increases production of inositol 1,4,5-triphosphate, and releases intracellular calcium.[A19402] Protein kinase A phosphorylates glycogen phosphorylase kinase, which phosphorylates glycogen phosphorylase, which phosphorylates glycogen, causing its breakdown.[A19402] Glucagon also relaxes smooth muscle of the stomach, duodenum, small bowel, and colon.[L7634,L7643] | Patients experiencing an overdose may present with nausea, vomiting, inhibition of GI tract motility, increased blood pressure and heart rate, and decreased serum potassium.[L7634,L7637,L7640,L7643] Phentolamine may be given to control blood pressure.[L7634,L7637,L7640,L7643] Treatment of glucagon overdose is largely symptomatic for nausea, vomiting, and hypokalemia.[L7637] The LD50 for intravenous glucagon in mice is 300mg/kg and in rats is 38.6mg/kg.[L7637] | Glucagon is a protein and so it is metabolized into smaller polypeptides and amino acids in the liver, kidney, and plasma.[L7634,L7643] | A 1mg intravenous dose of glucagon reaches a Cmax of 7.9ng/mL with a Tmax of 20 minutes.[L7637] An intramuscular dose reaches a Cmax of 6.9ng/mL with a Tmax of 13 minutes.[L7637] A 3mg dose of glucagon nasal powder reaches a Cmax of 6130pg/mL with a Tmax of 15 minutes.[L7643] | The volume of distribution of glucagon is 0.25L/kg.[L7637] The apparent volume of distribution is 885L.[L7643] | A 1mg intravenous dose of glucagon has a clearance of 13.5mL/min/kg.[L7637] | NA | NA | NA | NA | NA | Glucagon receptor,Glucagon-like peptide 2 receptor,Glucagon-like peptide 1 receptor | Gvoke PFS 1 mg Pre-filled Syringe | Xeris Pharmaceuticals, Inc. | Xeris Pharmaceuticals, Inc. | Subcutaneous | 1 mg/0.2mL | GVOKE is contraindicated in patients with: Pheochromocytoma Insulinoma [ see WARNINGS AND PRECAUTIONS] because of the risk of hypoglycemia Known hypersensitivity to glucagon or to any of the excipients in GVOKE. Allergic reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension. | nausea vomiting hives injection site swelling or redness headache fast heartbeat | Glucagon comes as a solution (liquid) in a prefilled syringe and an auto-injector device to inject subcutaneously (just under the skin). It also comes as a powder to be mixed with a provided liquid to be injected subcutaneously, intramuscularly (into the muscle), or intravenously (into a vein). It is usually injected as needed at the first sign of severe hypoglycemia. | Glucagon is used along with emergency medical treatment to treat very low blood sugar. Glucagon is also used in diagnostic testing of the stomach and other digestive organs. Glucagon is in a class of medications called glycogenolytic agents. It works by causing the liver to release stored sugar to the blood. It also works by relaxing smooth muscles of the stomach and other digestive organs for diagnostic testing. | (3S)-3-[[(2S)-5-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-6-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S,3R)-2-[[(2S)-2-[[(2S,3R)-2-[[2-[[(2S)-5-amino-2-[[(2S)-2-[[(2S)-2-amino-3-(1H-imidazol-5-yl)propanoyl]amino]-3-hydroxypropanoyl]amino]-5-oxopentanoyl]amino]acetyl]amino]-3-hydroxybutanoyl]amino]-3-phenylpropanoyl]amino]-3-hydroxybutanoyl]amino]-3-hydroxypropanoyl]amino]-3-carboxypropanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-3-hydroxypropanoyl]amino]hexanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-4-methylpentanoyl]amino]-3-carboxypropanoyl]amino]-3-hydroxypropanoyl]amino]-5-carbamimidamidopentanoyl]amino]-5-carbamimidamidopentanoyl]amino]propanoyl]amino]-5-oxopentanoyl]amino]-4-[[(2S)-1-[[(2S)-1-[[(2S)-5-amino-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-4-amino-1-[[(1S,2R)-1-carboxy-2-hydroxypropyl]amino]-1,4-dioxobutan-2-yl]amino]-4-methylsulfanyl-1-oxobutan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-3-(1H-indol-3-yl)-1-oxopropan-2-yl]amino]-1,5-dioxopentan-2-yl]amino]-3-methyl-1-oxobutan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]amino]-4-oxobutanoic acid | NA | Link | Link | NA |