This website is intended to provide community members with balanced clinical and scientific information on the safety and effectiveness of emicizumab-kxwh for educational purposes, and to support informed and meaningful treatment discussions with healthcare providers.
Our Commitment to Providing Updated and Timely Scientific and Clinical Information About Emicizumab-kxwh
This website is intended to provide community members with balanced clinical and scientific information on the safety and effectiveness of emicizumab-kxwh for educational purposes, and to support informed and meaningful treatment discussions with healthcare providers.
Welcome
The US Package Insert (Prescribing Information (Pl) or label) provides FDA-approved information about prescription medications and is the primary source of information about emicizumab.
The information on this site is not meant to take the place of important conversations with your healthcare provider. 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.
Available Resources
Emicizumab Data
Search Medical Information for Patients
Patient Medical Resources
Contact Information
Report a Side Effect
Genentech:
(888) 835-2555
(24 hrs/day, 7 days/week)
FDA:
(800) FDA-1088
(24 hrs/day, 7 days/week)
Report a Product Complaint (product quality issue or product abnormality)
Genentech:
(800) 334-0290
Monday – Friday
5:00am – 5:00pm PT
Important Safety Information & Indication
What is HEMLIBRA?
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. People who use activated prothrombin complex concentrate (aPCC; Feiba®) to treat breakthrough bleeds while taking HEMLIBRA may be at risk of serious side effects related to blood clots.
These serious side effects include:
Thrombotic microangiopathy (TMA), a condition involving blood clots and injury to small blood vessels that may cause harm to your kidneys, brain, and other organs
Blood clots (thrombotic events), which may form in blood vessels in your arm, leg, lung, or head
Talk to your doctor about the signs and symptoms of these serious side effects, which can include:
- Confusion
- Stomach, chest, or back pain
- Weakness
- Nausea or vomiting
- Swelling, pain, or redness
- Feeling sick or faint
- Decreased urination
- Swelling of arms and legs
- Yellowing of skin and eyes
- Eye pain, swelling, or trouble seeing
- Fast heart rate
- Numbness in your face
- Headache
- Shortness of breath
- Coughing up blood
If you experience any of these symptoms during or after treatment with HEMLIBRA, get medical help right away.
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. 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.
The most common side effects of HEMLIBRA include: injection site reactions (redness, tenderness, warmth, or itching at the site of injection), headache, and joint pain. These are not all of the possible side effects of HEMLIBRA. You can speak with your healthcare provider for more information.
What else should I know about HEMLIBRA?
See the detailed “Instructions for Use” that comes with your HEMLIBRA for information on how to prepare and inject a dose of HEMLIBRA, and how to properly throw away (dispose of) used needles and syringes.
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. 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.
The most common side effects of HEMLIBRA include: injection site reactions (redness, tenderness, warmth, or itching at the site of injection), headache, and joint pain. These are not all of the possible side effects of HEMLIBRA. You can speak with your healthcare provider for more information.
What else should I know about HEMLIBRA?
See the detailed “Instructions for Use” that comes with your HEMLIBRA for information on how to prepare and inject a dose of HEMLIBRA, and how to properly throw away (dispose of) used needles and syringes.
- Stop taking your prophylactic bypassing therapy the day before you start HEMLIBRA
- You may continue taking your prophylactic factor VIII for the first week of HEMLIBRA
HEMLIBRA may interfere with laboratory tests that measure how well your blood is clotting and create an inaccurate result. Speak with your healthcare provider about how this may affect your care.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Only use HEMLIBRA for the condition it was prescribed. Do not give HEMLIBRA to other people, even if they have the same symptoms that you have. It may harm them.
Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, or herbal supplements. Keep a list of them to show your healthcare provider and pharmacist.
Before using HEMLIBRA, tell your healthcare provider about all of your medical conditions, including if you are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed.
Since HEMLIBRA was tested in males, there is no information on whether HEMLIBRA may impact your unborn baby or breast milk. Females who are able to become pregnant should use birth control during treatment.
Side effects may be reported to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.
You may also report side effects to Genentech at (888) 835-2555.
Please see Important Safety Information, including Serious Side Effects, as well as the HEMLIBRA full Prescribing Information and Medication Guide.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Only use HEMLIBRA for the condition it was prescribed. Do not give HEMLIBRA to other people, even if they have the same symptoms that you have. It may harm them.
Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, or herbal supplements. Keep a list of them to show your healthcare provider and pharmacist.
Before using HEMLIBRA, tell your healthcare provider about all of your medical conditions, including if you are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed.
Since HEMLIBRA was tested in males, there is no information on whether HEMLIBRA may impact your unborn baby or breast milk. Females who are able to become pregnant should use birth control during treatment.
Side effects may be reported to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.
You may also report side effects to Genentech at (888) 835-2555.
Please see Important Safety Information, including Serious Side Effects, as well as the HEMLIBRA full Prescribing Information and Medication Guide.