Frequently Asked Questions About HEMLIBRA

HEMLIBRA is not an infusion.

HEMLIBRA is a medicine that is given as a shot that goes directly under the skin (a subcutaneous injection), so you don’t need to find a vein to take your dose of HEMLIBRA.

To learn more about how HEMLIBRA is taken, watch the injection video.

The term “half-life” in medicine means how long it takes for half the amount of a drug to leave the body. A long half-life means the medicine stays in your body longer.  The half-life of HEMLIBRA is 646 hours—or about 4 weeks. The half-life of factor VIII treatment can be up to 48 hours. Visit About HEMLIBRA to learn more.

HEMLIBRA can be taken once a week, once every 2 weeks, or once every 4 weeks. For the first 4 weeks of treatment only, you must use HEMLIBRA once a week. This will build up levels of HEMLIBRA in your blood. Your maintenance dose starts at Week 5. Your doctor will help you choose a dosing schedule that’s right for you.

Visit Dosing to learn more.

HEMLIBRA acts like a bridge, bringing factor IXa and factor X together to allow the blood coagulation process to continue without needing to replace factor VIII. Because HEMLIBRA is different from factor VIII, it works even in the presence of factor VIII inhibitors.

Mechanism of Action (MOA) of HEMLIBRA® (emicizumab-kxwh)

To learn more, download the How HEMLIBRA Works brochure.

HEMLIBRA is a therapeutic antibody, not a factor VIII replacement therapy. Because it is not factor VIII, it does not create factor VIII inhibitors. HEMLIBRA is also not impacted by existing factor VIII inhibitors. Visit About HEMLIBRA to learn more.

ADAs can occur when using HEMLIBRA. ADAs are our body’s natural reaction to molecules it detects as foreign—in this case, HEMLIBRA. It is important to know that ADAs differ from FVIII inhibitors and don't impact FVIII replacement therapy. Neutralizing ADAs are anti-drug antibodies that have the potential to make a medicine ineffective. Anti-emicizumab-kxwh antibodies were reported in 5.1% of patients treated with HEMLIBRA in clinical trials. Most patients with anti-emicizumab-kxwh 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 with decreasing plasma concentration may be associated with loss of efficacy. Be sure to speak with your healthcare provider if you have any questions about ADAs.

HEMLIBRA is a shot that goes directly under the skin (a subcutaneous injection), similar to the way someone with diabetes injects insulin. You don’t need to find a vein to take your dose of HEMLIBRA. It can take less than a minute to inject HEMLIBRA after it’s prepared.

Your healthcare provider will teach you how to prepare and inject HEMLIBRA. Note that self-injection is not recommended for children under the age of 7.

To learn more about how HEMLIBRA is injected, watch the injection video.

You may continue taking your prophylactic factor VIII for the first week of HEMLIBRA. Stop taking your prophylactic bypassing therapy the day before you start HEMLIBRA.

You can get a bleed while using HEMLIBRA. You and your healthcare provider should discuss a plan on when and how to treat and/or manage a bleed. It is important that you stick with the dosing and treatment plan you discussed with your healthcare provider.

If you miss a dose of HEMLIBRA on your scheduled day, you should take the dose as soon as you remember, then continue with your normal dosing schedule. Do not take 2 doses on the same day to make up for a missed dose.

More than 95% of insured people nationally have coverage for HEMLIBRA.*

*Coverage specific to Commercial and Medicaid and is defined as a payer with a published policy for HEMLIBRA. Data sourced from MMIT and DRG as of November 2022. Coverage may vary for individuals and plans. Not a representation or guarantee concerning coverage or reimbursement for HEMLIBRA.

No matter what type of health insurance you have, and even if you have none at all, there may be options available to help you afford 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.

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

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.

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

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.

You can also learn more about side effects of HEMLIBRA.

HEMLIBRA may interfere with laboratory tests that measure how well your blood is clotting and may cause a false reading. Before beginning treatment with HEMLIBRA, speak to your healthcare provider to discuss how this may affect your care. You may need to share this information with other healthcare providers, such as dentists, surgeons, or emergency room (ER) staff, prior to a blood test, medical procedure, or surgery.

Talk to your healthcare provider for specific guidance on recreational activities customized to your fitness goals. For additional information, please see the National Hemophilia Foundation’s Guidelines. (Genentech has no control over the content of this site and is not responsible for the information therein.) Note that these guidelines are for informational use only and based on statistics from a general population. Always talk to your doctor before taking on new recreational activities.

Talk to your healthcare provider about any upcoming medical procedure. Your healthcare provider can answer any questions if you have a surgical need coming up.

As of April 2023, more than 20,000 patients with hemophilia A with or without factor VIII inhibitors have been treated with HEMLIBRA globally.

The HEMLIBRA HAVEN clinical trial program began in patients with factor VIII inhibitors in 2015. HEMLIBRA was first approved in the US in November 2017 for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in people with hemophilia A with factor VIII inhibitors. In 2018, the indication for HEMLIBRA was expanded to include all hemophilia A patients with and without FVIII inhibitors, ages newborn and older, as prophylaxis.

Watch Patient Stories to hear from people like you about why they switched to HEMLIBRA.

Yes, HEMLIBRA has been studied for use in young children and is approved for children ages newborn and older with hemophilia A for routine prophylaxis to prevent or reduce the frequency of bleeding episodes. Read a summary of the HEMLIBRA clinical trial results in young children. Talk to your healthcare provider about whether HEMLIBRA may be right for your child.

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.