Welcome

Emicizumab-kxwh is an FDA approved prescription medicine used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A with or without factor 8 (factor VIII or FVIII) inhibitors. As of March 2020, more than 6,500 people with hemophilia A with and without FVIII inhibitors have received emicizumab-kxwh globally through clinical trials, expanded access, compassionate use, and following the FDA approval of emicizumab-kxwh (often referred to as postmarketing).

The US Package Insert (Prescribing Information [PI] or label) provides FDA-approved information about prescription medications and is the primary source of information about the known and potential risks of emicizumab-kxwh. The PI for emicizumab-kxwh includes a Medication Guide which contains FDA-approved information that can help people avoid serious side effects.

Click on a button below for safety data and information on thrombotic microangiopathy, serious thrombotic events (blood clots), or fatalities:

Click below for information presented at a scientific meeting (EAHAD 2020) on reported thrombotic microangiopathy (TMA) and thrombotic events (blood clots) received by Genentech as of December 2019:

Key details from the scientific presentation as well as information on thrombotic microangiopathy (TMA) and thrombotic events (blood clots) from clinical trials and can be found by clicking here.

For more details about the most frequently occurring side effects with emicizumab-kxwh, click below:

Our commitment through this website is to provide safety reports for thrombotic microangiopathy, serious thrombotic events (blood clots), and fatalities from ongoing emicizumab-kxwh clinical trials, expanded access, compassionate use, and experience after FDA approval. These safety reports contain sufficient details to verify the case and meet the reporting requirements for health authorities. After FDA approval, safety reports are reported voluntarily from patients and healthcare providers, and the amount of the information received varies. This site 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 related to serious side effects reported in the postmarketing setting because the level of detail available and Genentech/Roche's ability to confirm individual details is variable. In addition, patient privacy is very important to Genentech/Roche, therefore we are careful not to disclose specific details about a side effect that could jeopardize the privacy of either the patient or their family, or breach patient confidentiality.

The information on this site is not meant to take the place of important conversations with your healthcare provider.

Requirements after FDA approval for emicizumab-kxwh are on the US Food and Drug Administration website and can be accessed by clicking here.

Your healthcare provider should be the primary source of information about your medical condition and the safe and effective use of any medicine, including emicizumab-kxwh.

You may contact our Medical Communications department with questions specific to this site: (800) 821-8590, Monday- Friday, 5:00A – 5:00P PST.