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:

Fatalities

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.

Prescribing Information

The Prescribing Information is the primary source of information on the known and potential risks of emicizumab-kxwh for hemophilia A with 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 the FAQ.