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Author: Admin | 2025-04-28
From Wikipedia, the free encyclopedia Recombinant factor VIIaINN: Eptacog alfaClinical dataTrade namesNovoseven, Sevenfact, othersOther namesrFVIIa, Coagulation factor VIIa (recombinant), Coagulation factor VIIa (recombinant)-jncwBiosimilarsAryosevenAHFS/Drugs.comMonographLicense dataUS DailyMed: Coagulation factor VIIa (recombinant)PregnancycategoryAU: B1Routes ofadministrationIntravenous injectionATC codeB02BD08 (WHO) Legal statusLegal statusAU: S4 (Prescription only)UK: POM (Prescription only)[1]US: ℞-only[2][3]EU: Rx-only[4][5]In general: ℞ (Prescription only)IdentifiersCAS Number102786-61-8 DrugBankDB00036ChemSpidernoneUNIIAC71R787OVKEGGD00172Recombinant factor VIIa (rfVIIa) is a form of blood factor VII that has been manufactured via recombinant technology.[4][5] It is administered via an injection into a vein.[6][4][5] It is used to treat bleeding episodes in people who have acquired haemophilia, among other indications.[7] There are several disimilar forms, and biosimilars for each. All forms are activated.List of recombinant factor VIIa formulationsINNUSANBrand nameNotesEptacog alfa (activated)coagulation factor VIIa (recombinant)NovosevenOldest formulation, Baby hamster kidney cells (BHK).[7]Eptacog alfa (activated)coagulation factor VIIa (recombinant)Novoseven RTApproved in the US in 2008.[2] BHK cells.[2]Eptacog beta (activated)coagulation factor VIIa (recombinant)-jncwSevenfact (US), Cevenfacta (EU)Biosimilar, produced through rabbit milk.[8] Approved in the EU in 2022.[5]The most common side effects with Novoseven include venous thromboembolic events (problems caused by blood clots in the veins), rash, pruritus (itching), urticaria (hives), fever and reduced effectiveness of treatment.[4] The most common side effects with Cevenfacta include injection site discomfort and hematoma (a collection of blood under the skin) as well as injection-related reactions, an increase in body temperature, dizziness and headache.[5]Novoseven was approved for medical use in the European Union in February 1996,[4] and in the United States in March 1999.[9]Novoseven is indicated for the treatment of bleeding episodes and for the prevention of bleeding in surgical interventions or invasive procedures in people with acquired hemophilia.[9][7]Novoseven RT is indicated for the treatment of bleeding episodes and peri-operative management in adults and children with hemophilia A or B with inhibitors, congenital factor VII deficiency, and Glanzmann's thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets and for the treatment of bleeding episodes and peri-operative management in adults with acquired hemophilia.[6][2]Sevenfact [coagulation factor VIIa (recombinant)-jncw] is approved for use in the United States and is indicated for the treatment and control of bleeding episodes occurring in adults and adolescents twelve years of age and older with hemophilia A or B with inhibitors (neutralizing antibodies).[8][10][3]As of 2012, recombinant factor VIIa is not supported by the evidence for treating most cases of major bleeding.[11] There is a significant risk of arterial thrombosis with its use and thus, other than in those with factor VII deficiency or acquired hemophilia, it should only be given in clinical trials.[11] Recombinant human factor VII, while initially looking promising in intracerebral hemorrhage, failed to show benefit following further study and is no longer recommended.[12][13] A possible role in severe postpartum hemorrhage has been suggested.[14]In people with hemophilia type A and B who have a deficiency of factors VIII and IX, these two factors are administered for controlling bleeding or as prophylaxis medication before starting surgeries. However, in some cases they subsequently develop neutralizing antibodies, called inhibitors, against the drug. These inhibitors often increase over time and inhibit the action of coagulation
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