Drug updated on 4/17/2024
| 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
- 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.
Summary
- Antihemophilic factor (recombinant) (Advate) is indicated for use in children and adults with hemophilia A to control and prevent bleeding episodes, manage perioperative situations, and as routine prophylaxis to reduce the frequency of bleeding episodes.
- Two systematic reviews/meta-analyses were reviewed which provided insights into the efficacy of Advate in managing hemophilia A.
- The first review emphasized adherence to prophylactic treatment among young adults transitioning from childhood; it found that standard-dose therapy showed high adherence among this group leading to better joint health and improved quality of life.
- In developing countries like China where resources are limited, low-dose prophylaxis was administered but the study suggests that standard dose or individualized prophylaxis should be provided long term for preventing joint damage.
- The second review focused on acquired hemophilia patients treated with immunoadsorption (IA), an intervention used when there's a failed response to immunosuppressive treatment alone or uncontrollable bleeding episodes occur; pooled estimates suggested IA might be beneficial adjunctive treatment in these high-risk patients but future studies are needed for confirmation.
- Overall, both reviews highlighted lower annualized bleeding rates in patients receiving antihemophilic factor (recombinant) compared with those receiving on-demand treatment or those who discontinued prophylaxis indicating its effectiveness as a preventive measure against hemorrhages associated with Hemophilia A conditions.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Advate (antihemophilic factor (recombinant)) Prescribing Information. | 2023 | Takeda Pharmaceuticals U.S.A., Inc. Lexington, MA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Factor VIII replacement prophylaxis in patients with hemophilia A transitioning to adults: a systematic literature review. | 2021 | Orphanet Journal of Rare Diseases |
| Immunoadsorption for the treatment of acquired hemophilia: new observational data, systematic review, and meta-analysis. | 2021 | Transfusion Medicine Reviews |