 This is a letter from Takeda Pharmaceuticals U.S.A., Inc on March 18 for the bleeding disorders community. Global Discontinuation of HEMOFIL® M [Antihemophilic Factor (Human), Method M, Monoclonal Purified] and RECOMBINATE® [Antihemophilic Factor (Recombinant)] Dear Valued Patient, The purpose of this letter is to inform you that Takeda has decided to globally discontinue HEMOFIL® M [Antihemophilic Factor (Human), Method M, Monoclonal Purified] and RECOMBINATE® [Antihemophilic Factor (Recombinant)]. This was not a decision we made lightly. As the treatment landscape evolves, we decided to discontinue these medicines as hemophilia patients continue to transition to alternate treatment options in the space, including those within our own 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. We understand that this directly impacts you and are here to support the hemophilia community during this transition. We 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. Transitioning to Alternative Treatment We recommend beginning to have discussions with your healthcare team to ensure ample time for creating a longer-term, alternative treatment plan. For more than 70 years, we’ve pioneered innovations and worked tirelessly to improve the standard of care for hemophilia patients. We are proud to offer alternative treatment options within the Takeda factor VIII portfolio, namely ADVATE® [Antihemophilic Factor (Recombinant)] and ADYNOVATE® [Antihemophilic Factor (Recombinant), PEGylated], that may meet your individual needs and are similar to HEMOFIL M and RECOMBINATE. Please visit ADVATE.com and ADYNOVATE.com for more information.
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