Drug updated on 9/5/2024
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.
Latest News
Summary
- 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 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 |