Trade names NovoSeven, AryoSeven ATC code B02BD05 (WHO) | Routes of
administration Intravenous injection Legal status US: ℞-only | |
AHFS/Drugs.com Multum Consumer Information Pregnancy
category US: C (Risk not ruled out) | ||
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).
Contents
Medical use
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 body. rFVIIa, which is an activated form of factor VII, bypasses factors VIII and IX and causes coagulation without the need for factors VIII and IX. It 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.
Another possible use is for partial reversal of new oral anticoagulants such as dabigatran, rivaroxaban, or apixaban.
Mechanism of action
This treatment results in activation of the extrinsic pathway of blood coagulation.
Manufacture
rFVIIa is a glycoprotein which is produced by recombinant DNA technology. AryoSeven is formulated totally similar 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.
Military use
rFVIIa was used routinely in severely wounded American troops during the Iraq War, credited with saving many lives but also resulting in a high number of deep venous thromboses and pulmonary emboli, as well as unexpected strokes, heart attacks, and deaths.