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| Primary information |
|---|
| ID | 10194 |
| Therapeutic ID | Th1025 |
| Protein Name | Intravenous Immunoglobulin |
| Sequence | >Th1025_Intravenous_Immunoglobulin
PSALTQPPSASGSLGQSVTISCTGTSSDVGGYNYVSWYQQHAGKAPKVIIYEVNKRPSGVPDRFSGSKSGNTASLTVSGLQAEDEADYYCSSYEGSDNFVFGTGTKVTVLGQPKANPTVTLFPPSSEELQANKATEVCLISDFYPGAVTVAWKADGSPVKAGVETTKPSKQSNNKYAASSYLSLTPEQWKSHRSYSCQVTHEGSTVEKTVAPTECSPLVLQESGPGLVKPSEALSLTCTVSGDSINTILYYWSWIRQPPGKGLEWIGYIYYSGSTYGNPSLKSRVTISVNTSKNQFYSKLSSVTAADTAVYYCARVPLVVNPWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPQPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPQVKFNWYVDGVQVHNAKTKPREQQYNSTYRVVSVLTVLHQNWLDGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSL
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| Molecular Weight | 142682.3 |
| Chemical Formula | C6332H9826N1692O1980S42 |
| Isoelectric Point | 8.13 |
| Hydrophobicity | -0.331 |
| Melting point | 71 |
| Half-life | 20 hours (mammalian reticulocytes, in vitro) |
| Description | 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. |
| Indication/Disease | 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. |
| Pharmacodynamics | Used as 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. |
| Mechanism of Action | 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 taggingor 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. |
| Toxicity | NA |
| Metabolism | NA |
| Absorption | NA |
| NA |
| Clearance | NA |
| Categories | Amino Acids, Peptides, and Proteins, Antibodies, Antigen Neutralization, Blood Proteins, Globulins, Human Immunoglobulin G, Immunoglobulin G, Immunoglobulin Isotypes, Immunoglobulins, Immunologic Factors, Immunoproteins, Passively Acquired Immunity, Proteins, Serum, Serum Globulins |
| Patents Number | NA |
| Date of Issue | NA |
| Date of Expiry | NA |
| Drug Interaction | NA |
| Target | NA |
| Brand Name | Asceniv |
| Company | Adma Biologics, Inc. |
| Brand Description | Adma Biologics, Inc. |
| Prescribed For | used to treat the symptoms of Primary Immunodeficiency Syndrome (PI), Immune Thrombocytopenic Purpura (ITP), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Bone Marrow Transplant, B-cell Chronic Lymphocytic Leukemia, Multifocal Motor Neuropathy, and Dermatomyositis. |
| Chemical Name | NA |
| Formulation | The manufacturing process of ASCENIV employs three steps to remove/inactivate adventitious viruses to minimize the risk of virus transmission. The steps are "Precipitation and removal of fraction III" during cold ethanol fractionation, classical "solvent/detergent treatment" and "35 nm virus filtration." In compliance with current guidelines, the steps have been separately validated in a series of in vitro experiments for their capacity to inactivate or remove both enveloped and nonenveloped viruses. |
| Physical Appearance | clear to opalescent liquid, which is colorless to pale yellow. |
| Route of Administration | Intravenous |
| Recommended Dosage | The recommended dose of ASCENIV for replacement therapy in primary humoral immunodeficiency (PI) is 300 to 800 mg/kg body weight administered every 3 to 4 weeks. The dose may be adjusted over time to achieve the desired trough levels and clinical response. |
| Contraindication | ASCENIV is contraindicated in: patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. IgA-deficiency patients with antibodies to IgA and a history of hypersensitivity. |
| Side Effects | hives, difficulty breathing, swelling of your face, lips, tongue, or throat, dizziness, nausea, lightheadedness, sweating, headache, pounding in your neck or ears, fever, chills, chest tightness, warmth or redness in your face, pale or yellowed skin, dark colored urine, fever, confusion, weakness, increased thirst or feeling hot, inability to urinate, heavy sweating, hot and dry skin, little or no urination, swelling, rapid weight gain, shortness of breath, chest pain, trouble breathing, blue colored lips, fingers, or toes, fever with severe headache, neck stiffness, eye pain, increased sensitivity to light, shortness of breath, chest pain with deep breathing, rapid heart rate, numbness or weakness on one side of the body, and welling and warmth, or discoloration in an arm or leg |
| Useful Link 1 | Link |
| Useful Link 2 | NA |
| Remarks | NA |