Our Commitment to Provide Transparent and Timely
Safety Information About Emicizumab-kxwh
Our commitment through this website is
to provide verified 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 are ones that contain sufficient details to verify the case and meet the reporting requirements for health authorities.
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
Important Safety Information & Indication
HEMLIBRA® is a prescription medicine used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, ages newborn and older, with hemophilia A with or without factor VIII inhibitors.
What is the most important information I should know about HEMLIBRA?
HEMLIBRA increases the potential for your blood to clot. Carefully follow your healthcare provider’s instructions regarding when to use an on-demand bypassing agent or factor VIII, and the dose and schedule to use for breakthrough bleed treatment. HEMLIBRA may cause the following serious side effects when used with activated prothrombin complex concentrate (aPCC; FEIBA®), including:
Thrombotic microangiopathy (TMA). This is a condition involving blood clots and injury to small blood vessels that may cause harm to your kidneys, brain, and other organs. Get medical help right away if you have any of the following signs or symptoms during or after treatment with HEMLIBRA:
Swelling of arms and legs
Yellowing of skin and eyes
Stomach (abdomen) or back pain
Nausea or vomiting
Blood clots (thrombotic events). Blood clots may form in blood vessels in your arm, leg, lung, or head. Get medical help right away if you have any of these signs or symptoms of blood clots during or after treatment with HEMLIBRA:
Swelling in arms or legs
Pain or redness in your arms or legs
Shortness of breath
Chest pain or tightness
Fast heart rate
Cough up blood
Numbness in your face
Eye pain or swelling
If aPCC (FEIBA®) is needed, talk to your healthcare provider in case you feel you need more than 100 U/kg of aPCC (FEIBA®) total.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.
You may also report side effects to Genentech at (888) 835-2555, 24
hrs/day, 7 days/week.