recombinant coagulation factor VIIa (Novo-Seven, rFVIIa, Niastase, Novo, Nordisk)
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Indications
- treatment of bleeding episodes in patients with hemophilia who have inhibitors to factor XIII or factor IX
- rapid reversal of excessive anticoagulation with warfarin (not recommended)[7]
- reversal of anticoagulation for urgent/emergency surgery NOT associated with bleeding
- used off-label in patients with central nervous system bleeding* & in patients with severe hemorrhage related to trauma, surgery, or liver disease[2][4]
* earlier report of improved 90 day outcome in patients with intracranial hemorrhage[2] has not been observed in other studies[4]
Contraindications
- of no benefit for intracranial hemorrhage[6]
Dosage
- single 3-5 minute intravenous infusion (40-160 ug/kg)
Storage
room temperature Phamacokinetics
- reduces INR immediately, followed by slow increase but < original value
- immediate resolution of active bleeding
Adverse effects
- serious adverse arterial thromboembolic events (5%)[2][3] including myocardial ischemia, myocardial infarction, cerebral ischemia &/or infarction
- off-label use associated with high risk for arterial thromboembolism[4]
Notes
- cost $204/ug (2005) 160 ug/kg for a 70 kg man would cost $20,000
- off label use high despite lack of evidence for reduction in mortality[5]
More general terms
References
- ↑ Journal Watch 23(4):31-32, 2003
- ↑ 2.0 2.1 2.2 2.3 Deveras RAE & Kessler CM Reversal of warfarin-induced excessive anticoagulation with recombinant human factor VIIa concentrate. Ann Intern Med 137:884, 2002 PMID: https://www.ncbi.nlm.nih.gov/pubmed/12458988
- ↑ 3.0 3.1 FDA Mewatch http://www.fda.gov/medwatch/safety/2005/safety05.htm#NovoSeven
- ↑ 4.0 4.1 4.2 4.3 Levi M et al. Safety of recombinant activated factor VII in randomized clinical trials. N Engl J Med 2010 Nov 4; 363:1791 PMID: https://www.ncbi.nlm.nih.gov/pubmed/21047223
Aledort LM. Off-label use of recombinant activated factor VII - Safe or not safe? N Engl J Med 2010 Nov 4; 363:1853. PMID: https://www.ncbi.nlm.nih.gov/pubmed/21047230 - ↑ 5.0 5.1 Logan AC et al. Off-label use of recombinant factor VIIa in U.S. hospitals: Analysis of hospital records. Ann Intern Med 2011 Apr 19; 154:516. PMID: https://www.ncbi.nlm.nih.gov/pubmed/21502649
Yank V et al. Systematic review: Benefits and harms of in-hospital use of recombinant factor VIIa for off-label indications. Ann Intern Med 2011 Apr 19; 154:529. PMID: https://www.ncbi.nlm.nih.gov/pubmed/21502651 - ↑ 6.0 6.1 The NNT: Recombinant Activated Factor VII for Acute Spontaneous Intracerebral Hemorrhage. http://www.thennt.com/nnt/factor-vii-for-intracerebral-hemorrhage/
Al-Shahi Salman R Haemostatic drug therapies for acute spontaneous intracerebral haemorrhage. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD005951 PMID: https://www.ncbi.nlm.nih.gov/pubmed/19821350
Diringer MN, Skolnick BE, Mayer SA et al Thromboembolic events with recombinant activated factor VII in spontaneous intracerebral hemorrhage: results from the Factor Seven for Acute Hemorrhagic Stroke (FAST) trial. Stroke. 2010 Jan;41(1):48-53. PMID: https://www.ncbi.nlm.nih.gov/pubmed/19959538 - ↑ 7.0 7.1 Medical Knowledge Self Assessment Program (MKSAP) 18, American College of Physicians, Philadelphia 2018