7 mins read

Overview: Hemlibra is given as an injection under your skin to help reduce or prevent bleeding episodes in people with hemophilia A. Common side effects include pain or itching where the medicine is given, headache, and joint pain. Serious side effects are less common, but they may include allergic reactions and blood clots. Get emergency help if you have trouble breathing, chest pain, vision changes, or sudden weakness on one side of your body.

Uses

What is Hemlibra used for?

Hemlibra (emicizumab-kxwh) is commonly used in certain people with hemophilia A, which is a condition that causes your blood to not clot properly, to prevent or reduce the frequency of bleeding episodes.

Hemlibra may also be used for other conditions as determined by your health care provider.

How does Hemlibra work (mechanism of action)?

Hemophilia A is a condition where your body does not make enough of a protein called factor VIII, which normally helps your body form blood clots to stop bleeding. It can take longer for your body to form blood clots if you do not have enough factor VIII. Hemlibra acts to connect two other proteins (factor IX and X) that help your body form blood clots to help prevent or reduce bleeding problems.

How is Hemlibra supplied (dosage forms)?

Brands and other names

  • Hemlibra

Dosage forms and strengths

  • 30 mg/mL, 60 mg/0.4 mL, 105 mg/0.7 mL, 150 mg/mL, 12 mg/0.4 mL solution for injection

How should I store Hemlibra?

Hemlibra should be stored in a refrigerator between 36 F and 46 F (2 C and 8 C). Do not freeze it. Keep it in the original carton to protect it from light. Do not shake Hemlibra.

Do not store any leftover Hemlibra for future use. Each vial is for single use. Any Hemlibra that is left in the vial after preparing your dose should be thrown away.

If needed, unopened vials of Hemlibra may be stored temporarily at room temperature up to 86 F (30 C) for a total of seven days. If stored at room temperature for less than seven days, it can be returned to the refrigerator. The maximum amount of time it can be stored at room temperature is a total of seven days.

Side Effects

What are the most common side effects of Hemlibra?

The most common side effects of Hemlibra are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Pain, itching, swelling, or redness near the injection site
  • Headache
  • Joint pain

There may be other side effects of Hemlibra that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Hemlibra?

While less common, the most serious side effects of Hemlibra are described below, along with what to do if they happen.

Severe Allergic Reactions. Hemlibra may cause allergic reactions, which can be serious. Stop using Hemlibra and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Damage to Small Blood Vessels. Hemlibra may cause a condition called thrombotic microangiopathy (TMA), where blood clots form in your small blood vessels. TMA can cause damage to other organs in your body, including your kidneys and brain. This seems much more likely to happen if you have to use other treatments to stop bleeding while you are using Hemlibra. See the Interactions section for more details. This can even happen up to six months after your last dose of Hemlibra because it stays in your body for a long time. Stop using Hemlibra and get emergency help if you have any of the following symptoms.

  • Confusion
  • Weakness
  • Swelling of your arms and legs
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
  • Stomach pain, nausea, or vomiting
  • Back pain
  • Feeling sick
  • Peeing less than than usual

Blood Clots. Hemlibra may cause blood clots in your arteries or veins. This could lead to serious conditions like a stroke, heart attack, or venous thromboembolism, such as a blood clot in the lungs (pulmonary embolism), deep veins (deep venous thrombosis or DVT), or eyes (retinal vein occlusion). This seems much more likely to happen if you have to use other treatments to stop bleeding while you are using Hemlibra. See the Interactions section for more details. This can even happen up to six months after your last dose of Hemlibra because it stays in your body for a long time. Stop using Hemlibra and get emergency help if you have any of the following signs of blood clots. 

  • Chest pain or pressure
  • Fast or abnormal heartbeat
  • Trouble breathing
  • Pain in your back, jaw, throat, or arm
  • Sweating, upset stomach, vomiting, or dizziness
  • Sudden weakness on one side of your body
  • Sudden and severe headache
  • Slurred speech or trouble understanding speech
  • Pain, swelling, or tenderness in your arm or leg
  • Vision loss
  • Bulging eyes 
  • Double vision

Antibodies. Rarely, your body may make antibodies (proteins made by your immune system to attack a foreign substance) against Hemlibra while you are using it. These antibodies can keep Hemlibra from working the way it should. Your health care provider may do blood tests to look for these antibodies. Keep all of your appointments, including those for lab work, while you are using Hemlibra. Tell your health care provider if you are bleeding more often or Hemlibra does not seem to be working as well as it used to. 

Warnings & Precautions

Who should not use Hemlibra?

Allergies to Ingredients. People who are allergic to any of the following should not use Hemlibra.

  • Emicizumab-kxwh
  • Hemlibra
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in the specific Hemlibra products they stock.

What should I know about Hemlibra before using it?

Do not use Hemlibra unless it has been prescribed to you by a health care provider. Use it as prescribed.

This medicine is injected under the skin. If you use Hemlibra at home, make sure that you or a caregiver understands how to properly prepare and use it. Read and follow the “Instructions for Use” that come with your medicine. If you have any questions, talk to your health care provider.

Do not share Hemlibra with other people, even if they have the same condition as you. It may harm them.

Keep Hemlibra out of the reach of children. As this medicine should be kept in a refrigerator, take special precautions to keep it away from children who also use the refrigerator.

Your health care provider will prescribe your dose of Hemlibra based on your weight. If your weight changes, tell your health care provider. They may need to adjust your dose.

Your health care provider will likely monitor your blood tests while you are using Hemlibra. Keep all appointments to have your blood checked.

Hemlibra may interfere with the results of certain blood tests, even up to six months after your last dose. Tell any health care providers who are doing blood tests that you use (or have used it within the last six months) Hemlibra. This may help them to better understand the results of your blood tests.

What should I tell my health care provider before using Hemlibra?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Hemlibra is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • History of blood clots, including a deep vein thrombosis (DVT), heart attack, or stroke
  • History of thrombotic microangiopathy (TMA) (see the Side Effects section for details)
  • Have antibodies against Hemlibra

Other Medicines and Supplements. Hemlibra may interact with other medicines and supplements. Before using Hemlibra, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if or how Hemlibra could affect pregnancy or harm a fetus. You should use effective birth control while you are using Hemlibra. Tell your health care provider if you are pregnant or plan to become pregnant. Your health care provider will let you know if you should use Hemlibra while you are pregnant or trying to get pregnant.

Breastfeeding. It is not known if Hemlibra passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should use Hemlibra while breastfeeding.

How can I get more information about Hemlibra?

For more information about Hemlibra, you can visit the drugmaker’s website at www.hemlibra.com or call them at 866-HEMLIBRA (866-436-5427).

Interactions

Does Hemlibra interact with foods or drinks?

There are no known interactions between Hemlibra and foods or drinks.

It is unknown if drinking alcohol will affect Hemlibra. However, alcohol can increase your risk of bleeding. It is best to limit the amount of alcohol that you drink.

Does Hemlibra interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using activated prothrombin complex concentrate (Feiba), which is a medicine used to treat and prevent bleeding in certain people before using Hemlibra.

This may not be a complete list of medicines that can interact with Hemlibra. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Hemlibra?

If you or someone else has used too much Hemlibra, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Hemlibra?

If you miss a dose, use it as soon as you remember. Then, continue with your normal dosing schedule. Do not use double or extra doses. Do not use two doses on the same day.