Drug updated on 11/1/2024
| Dosage Form | Injection (intravenous; 250, 500, 1000, 1500, 2000, 3000 or 4000 IU) |
| Drug Class | Recombinant antihemophilic factors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for use in children and adults with hemophilia A for control and prevention of bleeding episodes, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
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Summary
- This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
- Annualized Bleeding Rates (ABR): rVIII-SingleChain (lonoctocog alfa) showed similar ABR outcomes when compared with rAHF-PFM (octocog alfa) (RR (relative risk) = 0.74, 95% CI (confidence interval): 0.16–3.48) and rFVIIIFc (efmoroctocog alfa) (RR = 1.18, 95% CI: 0.85–1.65), indicating comparable effectiveness in bleeding control.
- Percentage of Patients with Zero Bleeds: The proportion of patients with zero bleeds was also similar between rVIII-SingleChain and rAHF-PFM (OR (odds ratio) = 1.34, 95% CI: 0.56–3.22) and between rVIII-SingleChain and rFVIIIFc (OR = 0.78, 95% CI: 0.47–1.31), supporting similar efficacy in preventing bleeding episodes across these treatments for severe hemophilia A.
- There is no safety information available in the reviewed studies.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Advate (antihemophilic factor (recombinant)) Prescribing Information. | 2023 | Takeda Pharmaceuticals U.S.A., Inc., Lexington, MA |