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Antihemophilic factor (recombinant)

(Advate®)

Advate®

Drug updated on 5/17/2024

Dosage FormInjection (intravenous; 250, 500, 1000, 1500, 2000, 3000 or 4000 IU)
Drug ClassRecombinant 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
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  • Antihemophilic factor (recombinant) (Advate) is indicated for use in children and adults with hemophilia A, where it aids in the control and prevention of bleeding episodes, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
  • Six studies provided a comparison between Advate and other drugs used for managing Hemophilia A.
  • Prophylactic treatment using antihemophilic factor (recombinant) significantly lowers both annualized bleeding rate and joint bleeding rate compared to episodic treatment across all dosages - low, intermediate, or high.
  • The effectiveness of different prophylactic clotting factor concentrate regimens showed no discernable difference in joint bleeding outcomes among various dosing strategies; however, they did show an improvement in reducing total bleed events.
  • Comparative analyses suggest that Advate has similar efficacy as other recombinant FVIII products but potentially greater efficiency due to lower annual consumption than rVIII-SingleChain.
  • Emicizumab was found to have a lower rate of treated bleeds when compared with FVIII prophylaxis, including Advate, suggesting superior efficacy within certain patient subgroups such as those without inhibitors.

Product Monograph / Prescribing Information

Document TitleYearSource
Advate (antihemophilic factor (recombinant)) Prescribing Information.2023Takeda Pharmaceuticals U.S.A., Inc., Lexington, MA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Effects of replacement therapies with clotting factors in patients with hemophilia: a systematic review and meta-analysis.2022PLoS One
Clotting factor concentrates for preventing bleeding and bleeding-related complications in previously treated individuals with haemophilia A or B.2021The Cochrane Database of Systematic Reviews
Matching-Adjusted indirect comparison of efficacy and consumption of rVIII-SingleChain versus two recombinant FVIII products used for prophylactic treatment of adults/adolescents with severe haemophilia A.2021Advances in Therapy
Efficacy, safety, and immunogenicity of rurioctocog alfa pegol for prophylactic treatment in previously treated patients with severe hemophilia A: a systematic review and meta-analysis of clinical trials.2021F1000Research
A systematic review evaluating the efficacy and factor consumption of long-acting recombinant factor VIII products for the prophylactic treatment of hemophilia A.2020Journal of Medical Economics
Efficacy of emicizumab prophylaxis versus factor VIII prophylaxis for treatment of hemophilia A without inhibitors: network meta-analysis and sub-group analyses of the intra-patient comparison of the HAVEN 3 trial.2019Current Medical Research and Opinion

Clinical Practice Guidelines

Document TitleYearSource
Classification of recombinant factor VIII products and implications for clinical practice: a systematic literature review.2024Haemophilia