Our Commitment to Safety Communication
Our commitment is to provide verified
safety reports* for thrombotic microangiopathy, serious thrombotic
events, and fatalities from ongoing emicizumab-kxwh clinical trials,
expanded access, compassionate use, and postmarketing experience
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 March 2019, more than 2,500 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
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:
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.
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
verify the case and meet the reporting requirements for health
authorities. Reports contained within this site include cases from
emicizumab-kxwh clinical trials, expanded access, and compassionate
use that may be assessed as related or unrelated to emicizumab-kxwh.
This site also contains cases from postmarketing spontaneous adverse
event reports. As of March 31, 2019 Genentech/Roche will not provide
additional details or assessments of relatedness for adverse events
reported in the postmarketing setting due to limitations in
reporting of postmarketing spontaneous events.
Data on file. Genentech, Inc. December 2018
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 December 2018
US National Library of Medicine. ClinicalTrials.gov. Glossary of Common Site Terms. https://clinicaltrials.gov/ct2/about-studies/glossary. Accessed December 2018
US Food and Drug Administration. Expanded Access (Compassionate Use)
https://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/default.htm. Accessed December 2018;
Jarow JP et al. Ther Innov Regul Sci. 2016;50(6):705-709
US Food and Drug Administration. Postmarketing Requirements and Commitments: Reports
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/ucm064436.htm. Accessed December 2018