Recombinant factor VIIa
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 haemophilia, among other indications. There are several disimilar forms, and biosimilars for each. All forms are activated.
| INN | USAN | Brand name | Notes |
|---|---|---|---|
| Eptacog alfa (activated) | coagulation factor VIIa (recombinant) | Novoseven | Oldest formulation, Baby hamster kidney cells (BHK). |
| Eptacog alfa (activated) | coagulation factor VIIa (recombinant) | Novoseven RT | Approved in the US in 2008. BHK cells. |
| Eptacog beta (activated) | coagulation factor VIIa (recombinant)-jncw | Sevenfact (US), Cevenfacta (EU) | Biosimilar, produced through rabbit milk. Approved in the EU in 2022. |
| 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 | |
| Pregnancy category |
|
| Routes of administration | Intravenous injection |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
|
| UNII | |
| KEGG | |
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 approved for medical use in the European Union in February 1996, and in the United States in March 1999.