The Prescribing Information is the primary source of information on the known and potential risks of emicizumab-kxwh for the prophylactic treatment of adult and pediatric patients with hemophilia A with or without factor VIII (FVIII) inhibitors. 

As of August 2018, more than 1,100 patients with hemophilia A with and without FVIII inhibitors have received emicizumab-kxwh globally through clinical trials, expanded access, compassionate use, and in the postmarketing setting.1

Global systems are in place to continuously monitor the safety of a drug.
Global safety data for emicizumab-kxwh and thrombotic microangiopathy, serious thrombotic events, and fatalities are currently available.1 Click below to learn more:

Postmarketing requirements and commitments2 are planned for emicizumab-kxwh. Click below to learn more from the FDA website:


HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.

Important Safety Information:

Cases of thrombotic microangiopathy and thrombotic events were reported when on average a cumulative amount of >100 U/kg/24 hours of activated prothrombin complex concentrate (aPCC) was administered for 24 hours or more to patients receiving HEMLIBRA prophylaxis. Monitor for the development of thrombotic microangiopathy and thrombotic events if aPCC is administered. Discontinue aPCC and suspend dosing of HEMLIBRA if symptoms occur.

Report an Adverse Event
Genentech 24 hrs/day, 7 days/week (888) 835-2555 and/or the FDA (800) FDA‑1088

Medical Communications:
Submit a question online
Phone: (800) 821‑8590
Hours: Monday–Friday, 5:00 am–5:00 pm PT

Contact a Medical Science Liaison (MSL):
Request follow-up with an MSL

*Reflects reports of thrombotic microangiopathy (TMA), serious thrombotic events, and fatal events with sufficient details to assess the case and meet the reporting requirements for health authorities. Reports contained within this site include cases that may be assessed as related or unrelated to emicizumab-kxwh.



Data on file. Genentech, Inc. August 2018


U.S. Food and Drug Administration. Postmarketing Requirements and Commitments for HEMLIBRA® (emicizumab-kxwh). Accessed August 2018


US National Library of Medicine. Glossary of Common Site Terms. Accessed August 2018


US Food and Drug Administration. Expanded Access (Compassionate Use) Accessed August 2018;


Jarow JP et al. Ther Innov Regul Sci. 2016;50(6):705-709


US Food and Drug Administration. Postmarketing Requirements and Commitments: Reports Accessed August 2018