 | This article may be in need of reorganization to comply with Wikipedia's layout guidelines. The reason given is: Information scattered in Medical use and jncw (rabbit) sections. (December 2023) |
| Clinical data | |
|---|---|
| Trade names | Novoseven, Sevenfact, others |
| Other names | rFVIIa, Coagulation factor VIIa (recombinant), Coagulation factor VIIa (recombinant)-jncw |
| Biosimilars | Aryoseven |
| AHFS/Drugs.com | Monograph |
| License data | |
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| Routes of administration | Intravenous injection |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
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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]
| 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 approved for medical use in the European Union in February 1996,[4] and in the United States in March 1999.[10]
- ^ "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.
- ^ a b c Cite error: The named reference
NovoSeven RT FDA labelwas invoked but never defined (see the help page). - ^ Cite error: The named reference
Sevenfact FDA labelwas invoked but never defined (see the help page). - ^ a b c d e "NovoSeven EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 27 February 2023.
- ^ a b c d e Cite error: The named reference
Cevenfacta EPARwas invoked but never defined (see the help page). - ^ Cite error: The named reference
FDA NovoSeven RTwas invoked but never defined (see the help page). - ^ a b Cite error: The named reference
NovoSeven FDA labelwas invoked but never defined (see the help page). - ^ a b Cite error: The named reference
FDA Sevenfact PRwas invoked but never defined (see the help page). - ^ Cite error: The named reference
FDA Sevenfactwas invoked but never defined (see the help page). - ^ Cite error: The named reference
FDA NovoSevenwas invoked but never defined (see the help page).
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