Drug updated on 11/1/2024
| Dosage Form | Lyophilized powder (intravenous; 1, 2, 5, 8 mg) |
| Drug Class | Human 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)
Latest News
Summary
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- In trauma surgery, one RCT (randomised controlled trial) with 48 participants comparing 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 PCC (Prothrombin complex concentrate) likely reduces the number of RBC units transfused intra-operatively compared to rFVIIa (MD (mean difference) -4.98 units, 95% CI -6.37 to -3.59).
- Very low-quality evidence suggests minimal or no difference in RBC (red blood cell) units transfused between PCC and rFVIIa in cardiac surgery (OR (odds ratio) 0.16, 95% CI (confidence interval) 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 Title | Year | Source |
|---|---|---|
| NovoSeven (coagulation factor VIIa (recombinant)) Prescribing Information. | 2020 | Novo Nordisk Inc., Plainsboro, NJ |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Pharmacological interventions for the prevention of bleeding in people undergoing definitive fixation or joint replacement for hip, pelvic and long bone fractures | 2023 | The Cochrane Database of Systematic Reviews |
| Prothrombin complex concentrate in cardiac surgery for the treatment of coagulopathic bleeding | 2022 | The Cochrane Database of Systematic Reviews |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Practical guidance of the GTH haemophilia board on the use of emicizumab in patients with haemophilia A | 2020 | Hämostaseologie |