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
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 haemophilia, among other indications.[7] There are several disimilar forms, and biosimilars for each. All forms are activated.

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) 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]

  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. ^ Cite error: The named reference FDA Sevenfact PR was invoked but never defined (see the help page).
  9. ^ Cite error: The named reference FDA NovoSeven was invoked but never defined (see the help page).