Recombinant factor VIIa

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).

Recombinant factor VIIa
Clinical data
Trade namesNovoSeven, AryoSeven
AHFS/Drugs.comMultum Consumer Information
License data
Pregnancy
category
  • US: C (Risk not ruled out)
    Routes of
    administration    		Intravenous injection
    ATC code
    Legal status
    Legal status
    Identifiers
    ChemSpider
    • none

    Medical use

    As of 2012, rFVIIa is not supported by the evidence for treating most cases of major bleeding.[1] There is a significant risk of arterial thrombosis with its use and thus, other than in those with factor VII deficiency, it should only be given in clinical trials.[1] Recombinant human factor VII, while initially looking promising in intracerebral hemorrhage, failed to show benefit following further study and is no longer recommended.[2][3]

    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, called inhibitors, against the drug. These inhibitors often 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 can't be given without inhibitor. It is important for some patients to shift to proper blood factors according to their inhibitor titer. 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.[4]

    For 2016, NovoSeven was the second costliest drug on a per-patient basis, with an average cost of $627,161.[5]

    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 similarly 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.[6][7]

    References
    1. 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" (PDF). Cochrane Database of Systematic Reviews. 3 (3): CD005011. doi:10.1002/14651858.CD005011.pub4. PMID 22419303.
    2. 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.
    3. 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.
    4. Throm Haemost 2012; 108:625
    5. https://www1.magellanrx.com/media/604882/2016mrxtrendreport_final.pdf
    6. http://www.baltimoresun.com/news/nation-world/bal-factor7part1-story.html#page=1
    7. Hodgetts, T. J.; Kirkman, E.; Mahoney, P. F.; Russell, R.; Thomas, R.; Midwinter, M. (2007-12-01). "UK Defence Medical Services Guidance for the Use of Recombinant Factor VIIA (RFVIIA) in the Deployed Military Setting". Journal of the Royal Army Medical Corps. 153 (4): 307–309. doi:10.1136/jramc-153-04-18. ISSN 0035-8665. PMID 18619169.
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