Coagulation factor VIIa, recombinant

(NovoSeven®)

Coagulation factor VIIa, recombinant

Drug updated on 9/5/2024

Dosage FormLyophilized powder (intravenous; 1, 2, 5, 8 mg)
Drug ClassCoagulation Factors VIIa
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

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

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Summary
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  • Novoseven (coagulation factor VIIa, recombinant) is indicated for the treatment of bleeding episodes and perioperative management in adults and children with hemophilia A or B with inhibitors, congenital Factor VII (FVII) deficiency, and Glanzmann’s thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets; and for the treatment of bleeding episodes and perioperative management in adults with acquired hemophilia.
  • This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
  • Effectiveness in maintaining haemostasis: Recombinant coagulation factor VIIa (rFVIIa) was found to be effective in maintaining haemostasis during and after non-orthopaedic surgeries, including dental surgeries, in adult patients with congenital haemophilia with inhibitors (PWHI) in 22 out of 32 major surgeries reviewed.
  • Duration of treatment: The duration of rFVIIa treatment post-operatively ranged from 3 days to 1 month, with most treatments lasting between 5 to 10 days.
  • Adverse events related to rFVIIa were rare, with thrombotic events occurring infrequently. The safety profile of rFVIIa was generally well tolerated in adult patients with congenital haemophilia with inhibitors undergoing non-orthopaedic or dental surgery.
  • The studies specifically focused on adult patients (≥18 years) with congenital haemophilia with inhibitors undergoing non-orthopaedic or dental surgery, with no reported significant differences in effectiveness among various population types or subgroups.

Product Monograph / Prescribing Information

Document TitleYearSource
NovoSeven (coagulation Factor VIIa) Prescribing Information.2020Novo Nordisk, Bagsvaerd, Denmark

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines