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Information you should know about HEMLIBRA

Together, you can create a plan that works for you. Here are some important topics to review with your healthcare provider.

Your healthcare provider will teach you how to inject HEMLIBRA. They can also let you know what supplies you will need. Ask your healthcare provider for suggestions or tips on how to stick with your new treatment schedule.

  • HEMLIBRA is not a cure for hemophilia
  • HEMLIBRA is for routine prophylactic use only. It should not be used in emergencies to treat a bleed (on-demand therapy)
  • You can get a bleed while taking HEMLIBRA. You and your healthcare provider should create a plan on when and how to treat or manage a bleed
  • 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 (FVIII) and the recommended 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
  • If you have hemophilia A without FVIII inhibitors, you can use your factor VIII as recommended by your doctor

Being ready for an emergency situation is important. Consider updating your emergency medical information. It helps to know what to do if a trip to the emergency room (ER) is necessary.

  • Medical alert bracelets and wallet or phone cards are common ways to keep information handy during an emergency. Download our ER card here
  • Many smartphones have a “health” or “medical ID” function that allows important information to be accessed in an emergency without a password
  • You may also want to talk to your healthcare provider about a travel letter. This provides information about your condition, medications taken, and supplies you need to carry

HEMLIBRA may cause serious side effects when used with activated prothrombin complex concentrate (aPCC; Feiba®), including thrombotic microangiopathy (TMA), and blood clots (thrombotic events). 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.

Some lab tests that measure how well your blood is clotting may be impacted by HEMLIBRA. This could cause incorrect test results. Ask what information you should share with a healthcare provider prior to a medical procedure (eg, surgery, dental cleaning).

  • ADAs are our body’s natural reaction to medicines that seem foreign
  • ADAs are not FVIII inhibitors and do not impact factor VIII replacement therapy or other medicines
  • Some ADAs have the potential to neutralize HEMLIBRA, making it less effective. Be sure to speak with your healthcare provider if you have questions about ADAs

Treatment with HEMLIBRA may induce anti-drug antibodies. Anti-drug antibodies were reported in 5.1% of patients (34/668) treated with HEMLIBRA in clinical trials. Most patients with anti-drug antibodies did not experience a change in HEMLIBRA plasma concentrations or an increase in bleeding events. However, in uncommon cases (incidence <1%), the presence of neutralizing antibodies may make HEMLIBRA less effective.

Use HEMLIBRA exactly as it’s prescribed

While medicines are sometimes prescribed for some reasons not listed in the Medication Guide, do not use HEMLIBRA for a condition for which it was not prescribed. Do not give HEMLIBRA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for more information about HEMLIBRA.

Learn more about what you need to know before starting HEMLIBRA.

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Whether you are considering HEMLIBRA or are already on treatment, ACMs are here to help answer all your HEMLIBRA questions—everything from how HEMLIBRA works to understanding insurance coverage options. ACMs are Genentech employees and do not provide medical advice. Always talk to your doctor about treatment options.

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NEXT: Important Safety Information

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. 

Your body may make antibodies against HEMLIBRA, which may stop HEMLIBRA from working properly. Contact your healthcare provider immediately if you notice that HEMLIBRA has stopped working for you (eg, increase in bleeds).

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.