Takeda has decided to globally discontinue HEMOFIL® M [Antihemophilic Factor (Human), Method M, Monoclonal Purified] and RECOMBINATE® [Antihemophilic Factor (Recombinant)]
May 15, 2025
Takeda has decided to globally discontinue HEMOFIL® M [Antihemophilic Factor (Human), Method M, Monoclonal Purified] and RECOMBINATE® [Antihemophilic Factor (Recombinant)].
Takeda decided to discontinue these medicines as hemophilia patients continue to transition to alternate treatment options in the space, including those within Takeda's hematology portfolio. It is important to note there is no quality issue with either HEMOFIL M or RECOMBINATE and that their safety and efficacy remains consistent with the product Prescribing Information.
Takeda understands the significant impact this has on patients who rely on these medications and is committed to supporting the hemophilia community throughout this transition. They intend to supply HEMOFIL M and RECOMBINATE to patients already receiving these medicines until inventory is depleted or expired in mid-2026. Exact timing will vary based on potency and demand.
Alternative Takeda Treatments
Please read the Patient Letter. Takeda kindly asks that you share this letter with your HEMOFIL M and RECOMBINATE patients to help inform them of the global discontinuation of these medicines and encourage them to discuss alternative individual treatment plans with their healthcare provider.1
Takeda offers alternative treatment options within the Takeda factor VIII portfolio, namely ADVATE® [Antihemophilic Factor (Recombinant)] and ADYNOVATE® [Antihemophilic Factor (Recombinant), PEGylated], that may meet your patient's needs and are similar to HEMOFIL M and RECOMBINATE. Please visit ADVATEpro.com and ADYNOVATEpro.com for more information.1
Indications and Limitation of Use
ADYNOVATE and ADVATE are each a human, recombinant antihemophilic factor indicated in children and adults with hemophilia A (congenital factor VIII deficiency or "classic" hemophilia) for:
- On-demand treatment and control of bleeding episodes
- Perioperative management
- Routine prophylaxis to reduce the frequency of bleeding episodes
RECOMBINATE is indicated in hemophilia A (classical hemophilia) for:
- Prevention and control of hemorrhagic episodes
- Perioperative management
HEMOFIL M is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.
ADYNOVATE, ADVATE, RECOMBINATE and HEMOFIL M are not indicated for the treatment of von Willebrand disease.
Takeda Support
Takeda's commitment to supporting the hemophilia community throughout this transition remains strong and unwavering. For more information, visit HemophiliaJourney.com or contact your Takeda Account Director.
For patients prescribed a Takeda treatment, our dedicated Takeda Patient Support team is available to direct them to financial assistance options and insurance support, help them get their medication delivered and help them understand their condition and prescribed Takeda treatment. To learn more about Takeda Patient Support, visit TakedaPatientSupport.com or call 1-888-229-8379, Monday - Friday, 8 AM to 8 PM ET.
Resouces
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