Frequently Asked Questions About HEMLIBRA

How is HEMLIBRA different from factor VIII?

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 22 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. They are not inhibitors and do not impact factor VIII replacement therapy or other medicines. Neutralizing ADAs are anti-drug antibodies that have the potential to make a medicine ineffective. The incidence of ADAs in clinical trials was 3.5%, with <1% ADAs with neutralizing potential. There was no apparent impact of the presence of ADAs on safety. The number of patients with HEMLIBRA-related ADAs may be underreported due to the sensitivity of the test used to detect them. Be sure to speak with your healthcare provider if you have any questions about ADAs.

How is HEMLIBRA taken?

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.

Are there any patient financial assistance resources for HEMLIBRA?

>95% of people nationally have insurance coverage for HEMLIBRA.*

*Coverage defined as a payer with a published policy for HEMLIBRA. Coverage may vary for individual and plan. Data as of May 2021.

HEMLIBRA Access Solutions® can help you understand your health insurance coverage for your HEMLIBRA.

The HEMLIBRA Co-pay Program can help you with the out-of-pocket costs for your HEMLIBRA, if you’re eligible.*

If you don’t have insurance coverage or have financial concerns and meet eligibility criteria, you may be able to get free medicine from the Genentech Patient Foundation.

Learn about our different financial assistance options and services here.

*Eligibility criteria apply. Not valid for patients using federal or state government programs to pay for their medications and or administration of their Genentech medication. Patients must be taking the Genentech medication for an FDA- approved indication. See full Terms and Conditions at HEMLIBRAcopay.com/.

Under the program, the patient will pay a co-pay. After reaching the maximum program benefit, the patient will be responsible for all remaining out-of-pocket expenses. The amount of the program benefit cannot exceed the patients’ out-of-pocket expenses for the cost associated with HEMLIBRA.

All participants are responsible for reporting the receipt of all program benefits as required by any insurer or by law. No party may seek reimbursement for all or any part of the benefit received through this Program. The program is only valid in the United States and U.S. Territories. This program is void where prohibited by law and shall follow state restrictions in relation to AB-rated generic equivalents (e.g., MA, CA) where applicable. The patient, guardian, prescriber, hospital and any other person using the program agree not to seek reimbursement for all or any part of the benefit received by the patient through the offer of this program. Genentech reserves the right to rescind, revoke or amend the program without notice at any time. Additional terms and conditions apply. Please visit https://hemlibracopay.com/patients for the full list of Terms and Conditions.

If you have health insurance, you must have already tried other types of financial assistance. You also need to meet income requirements. If you do not have insurance, or if your insurance does not cover your Genentech medicine, you must meet different income requirements.

What should I know about HEMLIBRA safety and side effects?

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.

When was HEMLIBRA approved in the US/How many people are currently on it?

As of October 2021, more than 12,500 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 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.