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Recombinant factor VIIa

Medication


Medication

FieldValue
S28
INNEptacog alfa
caption
tradenameNovoseven, Sevenfact, others
Drugs.com
DailyMedIDCoagulation factor VIIa (recombinant)
pregnancy_AUB1
routes_of_administrationIntravenous injection
ATC_prefixB02
ATC_suffixBD08
biosimilarsAryoseven
<!-- Legal status -->legal_AUS4
legal_BR
legal_CA
legal_DE
legal_NZ
legal_UKPOM
legal_UK_comment
legal_USRx-only
legal_US_comment
legal_EURx-only
legal_EU_comment
legal_UN
legal_statusRx-only
excretion
CAS_number_Ref
CAS_number102786-61-8
DrugBankDB00036
ChemSpiderIDnone
KEGGD00172
UNIIAC71R787OV
synonymsrFVIIa, Coagulation factor VIIa (recombinant), Coagulation factor VIIa (recombinant)-jncw
<!-- Chemical and physical data -->C1982
H3054
N560
O618

| Drugs.com =

| elimination_half-life =

Recombinant factor VIIa (rfVIIa) is a form of blood factor VII that has been manufactured via recombinant technology. It is administered via an injection into a vein. It is used to treat bleeding episodes in people who have acquired hemophilia, among other indications.

INNUSANBrand nameNotes
Eptacog alfa (activated)coagulation factor VIIa (recombinant)NovosevenOldest formulation, Baby hamster kidney cells (BHK).
Eptacog alfa (activated)coagulation factor VIIa (recombinant)Novoseven RTApproved in the US in 2008. BHK cells.
Eptacog beta (activated)coagulation factor VIIa (recombinant)-jncwSevenfact (US), Cevenfacta (EU)Produced through rabbit milk. Approved in the US in 2020, and in the EU in 2022.

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. 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.

Novoseven was authorized for medical use in the European Union in February 1996, and in the United States in March 1999.

Medical uses

References

  1. (21 November 2019). "NovoSeven 1 mg (50KIU) powder and solvent for solution for injection - Summary of Product Characteristics (SmPC)".
  2. (17 September 2018). "NovoSeven EPAR".
  3. (1 October 2017). "NovoSeven".
  4. "NovoSeven Coagulation Factor VIIa (Recombinant) For Intravenous Use Only". Novo Nordisk.
  5. (22 July 2017). "NovoSeven RT".
  6. "NovoSeven RT (coagulation factor viia- recombinant kit". Novo Nordisk.
  7. (1 April 2020). "Sevenfact coagulation factor VIIa (recombinant)-jncw".
  8. (12 April 2020). "Sevenfact- coagulation factor viia recombinant human kit".
  9. (March 2012). "Recombinant factor VIIa for the prevention and treatment of bleeding in patients without haemophilia". The Cochrane Database of Systematic Reviews.
  10. (February 2005). "Recombinant activated factor VII for acute intracerebral hemorrhage". The New England Journal of Medicine.
  11. (May 2008). "Efficacy and safety of recombinant activated factor VII for acute intracerebral hemorrhage". The New England Journal of Medicine.
  12. (July 2020). "International recommendations on the diagnosis and treatment of acquired hemophilia A". Haematologica.
  13. (17 May 2022). "Cevenfacta EPAR".
  14. "Cevenfacta Product information".
  15. (1 April 2020). "FDA Approves Additional Treatment for Adults and Adolescents with Hemophilia A or B and Inhibitors".
  16. (19 May 2022). "Cevenfacta: Pending EC decision".
  17. (19 November 2006). "Dangerous Remedy".
  18. (December 2007). "UK defence medical services guidance for the use of recombinant factor VIIa (rFVIIa) in the deployed military setting". Journal of the Royal Army Medical Corps.
  19. (May 2024). "Rationale for the Potential Use of Recombinant Activated Factor VII in Severe Post-Partum Hemorrhage". J Clin Med.
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