Drug updated on 4/17/2024
| Dosage Form | Lyophilized powder (intravenous; 1, 2, 5, 8 mg) |
| Drug Class | Coagulation 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.
Summary
- Coagulation factor VIIa, recombinant (NovoSeven) 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 deficiency, Glanzmann's thrombasthenia refractory to platelet transfusions, as well as in adults with acquired hemophilia.
- The information was derived from a single systematic review/meta-analysis that discussed NovoSeven's use in non-orthopedic surgery, including dental surgery for adult patients with congenital hemophilia who have inhibitors.
- NovoSeven has been shown to maintain hemostasis during and after most major surgeries. Positive outcomes were observed in 22 out of 32 major surgeries reviewed within this specific patient population and surgical context.
- Regarding the safety profile, coagulation factor VIIa (NovoSeven) was generally well-tolerated by patients undergoing non-orthopedic or dental surgical procedures. Adverse events were rare, specifically thrombotic events, suggesting a favorable safety profile within this scope.
- While direct comparisons are not available from the study reviewed, it can be inferred that due to its rarity of adverse effects, particularly thrombotic ones, compared to other treatments, NovoSeven might have a comparable or better safety profile, especially among individuals suffering from congenital hemophilia with inhibitors, which pose unique challenges when managing bleeding conditions.
- The data highlights the utility of coagulation factor VIIa (NovoSeven) among adult patients with congenital hemophilia along with the presence of inhibitors, thus indicating its potential superiority over treatments not tailored towards overcoming such inhibitory conditions present across similar subgroups.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| NovoSeven (coagulation Factor VIIa) Prescribing Information. | 2020 | Novo Nordisk, Bagsvaerd, Denmark |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Recombinant FVIIa in elective non-orthopaedic surgery of adults with haemophilia and inhibitors: a systematic literature review. | 2021 | Haemophilia |
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 |