Coagulation factor VIIa (recombinant)

(NovoSeven®)

NovoSeven®

Drug updated on 12/11/2024

Dosage FormLyophilized powder (intravenous; 1, 2, 5, 8 mg)
Drug ClassHuman blood coagulation factors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for treatment of bleeding episodes and perioperative management in adults and children with hemophilia A or B with inhibitors, congenital Factor VII (FVII) deficiency, and Glanzmanns thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets
  • Indicated for treatment of bleeding episodes and perioperative management in adults with acquired hemophilia (1)

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Summary
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  • This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
  • In trauma surgery, one randomised controlled trial (RCT) with 48 participants comparing recombinant activated factor VII (rFVIIa) to placebo for reducing blood loss in hip, pelvic, and long bone fixation provided inconclusive effectiveness data due to a limited sample size.
  • In cardiac surgery, moderate-quality evidence from a non-randomized study indicates that prothrombin complex concentrate (PCC) likely reduces the number of red blood cell (RBC) units transfused intra-operatively compared to rFVIIa (mean difference (MD) -4.98 units, 95% confidence interval (CI) -6.37 to -3.59).
  • Very low-quality evidence suggests minimal or no difference in RBC units transfused between PCC and rFVIIa in cardiac surgery (odds ratio (OR) 0.16, 95% CI 0.02 to 1.56).
  • There is no specific safety information available for rFVIIa in trauma surgery due to limited data from the single included trial.
  • In cardiac surgery, very low-quality evidence suggests PCC may have little to no effect compared to rFVIIa on thrombotic events (OR 0.51, 95% CI 0.23 to 1.16), mortality (OR 1.07, 95% CI 0.38 to 3.03), and intensive care length of stay (MD -40 hours, 95% CI -110.41 to 30.41), while potentially reducing bleeding (MD -674.34 mLs, 95% CI -906.04 to -442.64) and renal replacement therapy incidence (OR 0.29, 95% CI 0.12 to 0.71).
  • There is no population types or subgroups information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
NovoSeven (coagulation factor VIIa (recombinant)) Prescribing Information.2020Novo Nordisk Inc., Plainsboro, NJ

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines