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| Primary information |
|---|
| ID | 13066 |
| Therapeutic ID | Th1378 |
| Protein Name | Fibrinogen human |
| Sequence | >Th1378_Fibrinogen_human
MKRMVSWSFHKLKTMKHLLLLLLCVFLVKSQGVNDNEEGFFSARGHRPLDKKREEAPSLRPAPPPISGGGYRARPAKAAATQKKVERKAPDAGGCLHADPDLGVLCPTGCQLQEALLQQERPIRNSVDELNNNVEAVSQTSSSSFQYMYLLKDLWQKRQKQVKDNENVVNEYSSELEKHQLYIDETVNSNIPTNLRVLRSILENLRSKIQKLESDVSAQMEYCRTPCTVSCNIPVVSGKECEEIIRKGGETSEMYLIQPDSSVKPYRVYCDMNTENGGWTVIQNRQDGSVDFGRKWDPYKQGFGNVATNTDGKNYCGLPGEYWLGNDKISQLTRMGPTELLIEMEDWKGDKVKAHYGGFTVQNEANKYQISVNKYRGTAGNALMDGASQLMGENRTMTIHNGMFFSTYDRDNDGWLTSDPRKQCSKEDGGGWWYNRCHAANPNGRYYWGGQYTWDMAKHGTDDGVVWMNWKGSWYSMRKMSMKIRPFFPQQ
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| Molecular Weight | NA |
| Chemical Formula | NA |
| Isoelectric Point | NA |
| Hydrophobicity | NA |
| Melting point | NA |
| Half-life | 78.7 hours |
| Description | Fibrinogen concentrate (human) is a hematological agent. It works by replacing a certain protein in the blood that helps with blood clotting. Fibrinogen (factor I) is a soluble plasma glycoprotein with a molecular weight of about 340 kDa. It is a physiological substrate for three enzymes: plasmin, factor XIIIa and thrombin. It is indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. |
| Indication/Disease | For the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. |
| Pharmacodynamics | Fibrinogen replaces the missing, or low coagulation factor. |
| Mechanism of Action | Fibrinogen (factor I) is a soluble plasma glycoprotein with a molecular weight of about 340 kDa. The native molecule is a dimer and consists of three pairs of polypeptide chains (Aa, Bß and ). Fibrinogen is a physiological substrate of three enzymes: thrombin, factor XIIIa, and plasmin. During the coagulation process, thrombin cleaves the Aa and Bß chains releasing fibrinopeptides A and B (FPA and FPB, respectively). FPA is separated rapidly and the remaining molecule is a soluble fibrin monomer (fibrin I). The slower removal of FPB results in formation of fibrin II that is capable of polymerization that occurs by aggregation of fibrin monomers. The resulting fibrin is stabilized in the presence of calcium ions and by activated factor XIII, which acts as a transglutaminase. Factor XIIIa-induced cross-linking of fibrin polymers renders the fibrin clot more elastic and more resistant to fibrinolysis. Cross-linked fibrin is the end result of the coagulation cascade, and provides tensile strength to a primary hemostatic platelet plug and structure to the vessel wall. |
| Toxicity | NA |
| Metabolism | NA |
| Absorption | Cmax is 140 mg/dL |
| Mean volume of distribution is 52.7 mL/kg. |
| Clearance | 0.59 mL/h/kg |
| Categories | Protein Precursors |
| Patents Number | NA |
| Date of Issue | NA |
| Date of Expiry | NA |
| Drug Interaction | NA |
| Target | NA |
| Brand Name | Fibryga |
| Company | Octapharma USA Inc |
| Brand Description | Octapharma USA Inc |
| Prescribed For | Intravenous |
| Chemical Name | 20 mg/1mL |
| Formulation | FIBRYGA is contraindicated in individuals who have manifested severe immediate hypersensitivity reactions, including anaphylaxis, to FIBRYGA or its components (Sodium Citrate Dihydrate; Glycine; L-Arginine hydrochloride). |
| Physical Appearance | vomiting, weakness, fever, blood clots, and anaphylactic type reactions |
| Route of Administration | FIBRYGA is a human plasma-derived, sterile, purified, virus-inactivated and nanofiltered (20 nm) fibrinogen concentrate. FIBRYGA is supplied as a lyophilized powder for reconstitution for intravenous injection. FIBRYGA contains no preservatives. Each bottle contains approximately 1 g of fibrinogen. The diluent for reconstitution of the lyophilized powder is sterile Water for Injection. |
| Recommended Dosage | FIBRYGA is a human fibrinogen concentrate indicated for the treatment of acute bleeding episodes in adults and adolescents with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. |
| Contraindication | NA |
| Side Effects | All units of human plasma used in the manufacture of FIBRYGA are provided by FDA-approved blood establishments, and are tested by FDA-licensed serological tests for Hepatitis B surface antigen (HBsAg), antibodies to Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-½. As an additional safety measure, the plasma is tested with Nucleic Acid Tests (NATs) for Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), HCV and HIV-1 and found to be non-reactive (negative). The plasma is also screened for Human Parvovirus (B19V) by NAT. The limit for B19V DNA in the mini-pool is set not to exceed 103 IU/mL. Only plasma that passed virus screening is used for production. |
| Useful Link 1 | Link |
| Useful Link 2 | Link |
| Remarks | NA |