Safety data from clinical trials, expanded access program, compassionate use, and postmarketing adverse event reports for thrombotic microangiopathy, serious thrombotic events, and fatalities are available and are updated* at least quarterly.
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Thrombotic Microangiopathy (TMA)
Emicizumab-kxwh and TMA:
Serious Thrombotic Events
Emicizumab-kxwh and serious thrombotic events:
Emicizumab-kxwh and fatalities:
Postmarketing requirements and commitments
Postmarketing requirements can be accessed directly on the U.S. Food and Drug Administration website for Postmarketing Requirements and Commitments for HEMLIBRA.
The Prescribing Information is the primary source of information on the known and potential risks of emicizumab-kxwh for hemophilia A with or without factor VIII (FVIII) inhibitors.
*Due to the nature of clinical trials, expanded access programs,
compassionate use, and postmarketing adverse event reports, some
investigations and assessments of these reports may be ongoing and
therefore may be subject to change. For more information, please see