Recombinant factor VIIa

Recombinant factor VIIa
INN: Eptacog alfa
Clinical data
Trade namesNovoseven, Sevenfact, others
Other namesrFVIIa, Coagulation factor VIIa (recombinant), Coagulation factor VIIa (recombinant)-jncw
BiosimilarsAryoseven
AHFS/Drugs.comMonograph
License data
Pregnancy
category
  • AU: B1
Routes of
administration		Intravenous injection
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only)
  • UK: POM (Prescription only)[1]
  • US: ℞-only[2][3]
  • EU: Rx-only[4][5]
  • In general: ℞ (Prescription only)
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG

Recombinant 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 hemophilia, among other indications.[7]

List of recombinant factor VIIa formulations
INN USAN Brand name Notes
Eptacog alfa (activated) coagulation factor VIIa (recombinant) Novoseven Oldest formulation, Baby hamster kidney cells (BHK).[7]
Eptacog alfa (activated) coagulation factor VIIa (recombinant) Novoseven RT Approved in the US in 2008.[2] BHK cells.[2]
Eptacog beta (activated) coagulation factor VIIa (recombinant)-jncw Sevenfact (US), Cevenfacta (EU) Produced through rabbit milk.[8] Approved in the US in 2020,[8][9] and 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 authorized for medical use in the European Union in February 1996,[4] and in the United States in March 1999.[10]

  1. ^ "NovoSeven 1 mg (50KIU) powder and solvent for solution for injection - Summary of Product Characteristics (SmPC)". (emc). 21 November 2019. Archived from the original on 15 January 2021. Retrieved 1 April 2020.
  2. ^ a b c Cite error: The named reference NovoSeven RT FDA label was invoked but never defined (see the help page).
  3. ^ Cite error: The named reference Sevenfact FDA label was invoked but never defined (see the help page).
  4. ^ a b c d e "NovoSeven EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 27 February 2023.
  5. ^ a b c d e Cite error: The named reference Cevenfacta EPAR was invoked but never defined (see the help page).
  6. ^ Cite error: The named reference FDA NovoSeven RT was invoked but never defined (see the help page).
  7. ^ a b Cite error: The named reference NovoSeven FDA label was invoked but never defined (see the help page).
  8. ^ a b Cite error: The named reference FDA Sevenfact PR was invoked but never defined (see the help page).
  9. ^ Cite error: The named reference FDA Sevenfact was invoked but never defined (see the help page).
  10. ^ Cite error: The named reference FDA NovoSeven was invoked but never defined (see the help page).
This article is issued from Wikipedia. The text is available under Creative Commons Attribution-Share Alike 4.0 unless otherwise noted. Additional terms may apply for the media files.