Recombinant factor VIIa
|This article needs additional citations for verification. (July 2012)|
|Trade names||NovoSeven, AryoSeven|
|Pregnancy cat.||C (US)|
|Legal status||℞-only (US)|
Recombinant factor VIIa (rFVIIa) is a form of blood factor VII that has been manufactured via recombinant technology. The most commonly used rFVIIa is eptacog alfa (INN, trade names NovoSeven and AryoSeven).
rFVIIa is not, as of 2012, supported by the evidence for most cases of major bleeding. There is a significant risk of arterial thrombosis with its use and thus other than in those with factor VII deficiency should only be given in clinical trials. Recombinant human factor VII, while initially looking promising in intracerebral hemorrhage, failed to show benefit following further study and is no longer recommended.
In people with hemophilia type A and B who have a deficiency of factors VIII and IX, these two factors are administered for controlling bleeding or as prophylaxis medication before starting surgeries. However, in some cases they subsequently develop neutralizing antibodies (NAb) against the drug. These NAbs increase over time and inhibit the action of (coagulation) in the persons body. rFVIIa, which is activated form factor VII, bypasses factors VIII and IX and causes coagulation of blood without the need for factors VIII and IX. This is important for some patients to shift to proper blood factors according to their level of NAbs. Other indications include use for patients with acquired hemophilia, people born with a deficiency of factor VII, and people with Glanzmann's thrombasthenia.
Mechanism of action
This treatment results in activation of the extrinsic pathway of blood coagulation.
rFVIIa is a glycoprotein which is produced by recombinant DNA technology. AryoSeven is formulated totally similar[clarification needed] to the original drug with the name of NovoSeven. The product is the first biosimilar or biogeneric of the above mentioned drug. This biomedicine is produced in baby hamster kidney cells (BHK) and has similar characteristics and functions with the native blood factor VII.
Route of administration
rFVIIa is normally administered intravenously (IV) under physician supervision.
- Simpson, E; Lin, Y; Stanworth, S; Birchall, J; Doree, C; Hyde, C (Mar 14, 2012). "Recombinant factor VIIa for the prevention and treatment of bleeding in patients without haemophilia.". Cochrane database of systematic reviews (Online) 3: CD005011. doi:10.1002/14651858.CD005011.pub4. PMID 22419303.
- Mayer S, Brun N, Begtrup K, Broderick J, Davis S, Diringer M, Skolnick B, Steiner T (2005). "Recombinant activated factor VII for acute intracerebral hemorrhage". N. Engl. J. Med. 352 (8): 777–85. doi:10.1056/NEJMoa042991. PMID 15728810.
- Mayer SA, Brun NC, Begtrup K, et al. (May 2008). "Efficacy and safety of recombinant activated factor VII for acute intracerebral hemorrhage". N. Engl. J. Med. 358 (20): 2127–37. doi:10.1056/NEJMoa0707534. PMID 18480205.
- Throm Haemost 2012; 108:625