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 factor VIII (FVIII) inhibitors.

As of March 2018, more than 600 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 HEMLIBRA is not approved for hemophilia A without FVIII inhibitors.

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:

Indication:

HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors.

Important Safety Information:
Boxed WARNING: THROMBOTIC MICROANGIOPATHY and THROMBOEMBOLISM

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:
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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.

References

1.

Data on file. Genentech, Inc. March 2018

2.

U.S. Food and Drug Administration. Postmarketing Requirements and Commitments for HEMLIBRA® (emicizumab-kxwh). https://www.accessdata.fda.gov/scripts/cder/pmc/index.cfm. Accessed March 2018