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Generic Name: emicizumab-kxwh
Dosage Form: Injection, for Subcutaneous Use
Date of Approval: November 16, 2017
Company: Genentech, Inc.

Treatment for: Hemophilia A with Inhibitors

FDA Approves Hemlibra

The U.S. Food and Drug Administration (FDA) has approved Hemlibra (emicizumab-kxwh), a bispecific factor IXa- and factor X-directed antibody indicated to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A with factor VIII inhibitors.

Medication Guide

Read this Medication Guide before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

Important information

Hemlibra increases the potential for your blood to clot. Discontinue prophylactic use of bypassing agents the day before starting treatment. Carefully follow your healthcare provider’s instructions regarding when to use an on-demand bypassing agent, and the dose and schedule you should use.

Hemlibra may cause the following serious side effects when used with 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:
    • confusion
    • weakness
    • swelling of arms and legs
    • yellowing of skin and eyes
    • stomach (abdomen) or back pain
    • nausea or vomiting
    • feeling sick
    • decreased urination
  • 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:
    • 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
    • feel faint
    • headache
    • numbness in your face
    • eye pain or swelling
    • trouble seeing

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.

See Hemlibra side effects for more information about side effects.

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 with hemophilia A with factor VIII inhibitors.

  • Hemophilia A is a bleeding condition people can be born with where a missing or faulty blood clotting factor (factor VIII) prevents blood from clotting normally.
  • Hemlibra is a therapeutic antibody that bridges clotting factors to help your blood clot.

Before using Hemlibra

Before using Hemlibra, tell your healthcare provider about all of your medical conditions, including if you:

  • are pregnant or plan to become pregnant. It is not known if this medicine may harm your unborn baby. Females who are able to become pregnant should use birth control (contraception) during treatment.
  • are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk.

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 when you get a new medicine.

How should I use Hemlibra?

See the detailed Instructions for Use that comes with your prescription for information on how to prepare and inject a dose of Hemlibra, and how to properly throw away (dispose of) used needles and syringes.

  • Use this medicine exactly as prescribed by your healthcare provider.
  • Hemlibra is given as an injection under your skin (subcutaneous injection) by you or a caregiver.
  • Your healthcare provider should show you or your caregiver how to prepare, measure, and inject your dose before you inject yourself for the first time.
  • Do not attempt to inject yourself or another person unless you have been taught how to do so by a healthcare provider.
  • Your healthcare provider will prescribe your dose based on your weight. If your weight changes, tell your healthcare provider.
  • If you miss a dose on your scheduled day, you should give the dose as soon as you remember. You must give the missed dose before the next scheduled dosing day and then continue with your normal weekly dosing schedule. Do not double your dose to make up for a missed dose.
  • Hemlibra may interfere with laboratory tests that measure how well your blood is clotting and may cause a false reading. Talk to your healthcare provider about how this may affect your care.

Hemlibra side effects

  • See Important information.

The most common side effects include:

  • redness, tenderness, warmth, or itching at the site of injection
  • headache
  • joint pain

These are not all of the possible side effects.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

How should I store Hemlibra?

  • Store the vials in the refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze.
  • Store the vials in the original carton to protect the vials from light.
  • Do not shake the vials.
  • If needed, unopened vials can be stored out of the refrigerator and then returned to the refrigerator. Hemlibra should not be stored out of the refrigerator for more than 7 days at 86°F (30°C) or below.
  • After Hemlibra is transferred from the vial to the syringe, the injection should be used right away.
  • Throw away (dispose of) any unused Hemlibra left in the vial.

Keep all medicines out of the reach of children and pets.

General information about the safe and effective use of Hemlibra.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it 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 information that is written for health professionals.

What are the ingredients in Hemlibra?

Active ingredient: emicizumab

Inactive ingredients: L-arginine, L-histidine, poloxamer 188, and L-aspartic acid.