Hemlibra

Hemlibra is a prescription medication used to prevent bleeding episodes in adults and children with hemophilia A (factor VIII deficiency) with factor VIII inhibitors, or factor VIII antibodies.

Hemlibra belongs to a group of drugs called blood coagulation factors. These work to activate substances in your blood to form clots and decrease bleeding episodes.

This medication is available in an injectable form to be given directly under the skin (subcutaneously) once weekly.

Common side effects of Hemlibra include a reaction at the site of injection, headache, and joint pain.

Hemlibra is a prescription medication used to prevent bleeding episodes in adults and children with hemophilia A (factor VIII deficiency) with factor VIII inhibitors, or factor VIII antibodies.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Hemlibra. See the “Hemlibra Precautions” section.

Common side effects of Hemlibra include the following:

• reaction at the site of injection such as redness, tenderness, warmth, or itching
• headache
• joint pain
• fever
• diarrhea
• muscle pain

This is not a complete list of Hemlibra side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take or receive:

• any blood products such as activated prothrombin complex concentrate (aPCC), recombinant factor VIIa (rFVIIa), or factor VIII (FVIII) 

This is not a complete list of Hemlibra drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Hemlibra including the following:

• thrombotic microangiopathy (TMA) when used with activated prothrombin complex concentrate (aPCC). TMA is when blood clots form in small blood vessels that can affect the kidneys, brain, and other organs. Call your healthcare provider immediately if you have symptoms of TMA which include:
  •  confusion
  • weakness
  • swelling of arms and legs
  • yellowing of skin or whites of eyes
  • abdomen (stomach) or back pain
  • nausea or vomiting
  • feeling sick
  • decreased urination
• blood clots in the arms, legs, lungs, or head. Call your healthcare provider immediately if you have symptoms of blood clots during or after treatment with Hemlibra including
  • swelling in arms or legs
  • pain or redness in arms or legs
  • shortness of breath
  • chest pain or tightness
  • fast heartbeat 
  • coughing up blood
  • feeling faint
  • headache
  • numbness in the face
  • eye pain or swelling
  • trouble seeing

Do not take Hemlibra if you are allergic to Hemlibra or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Hemlibra, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Hemlibra, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Hemlibra or to any of its ingredients
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Hemlibra should be given to a pregnant woman only if clearly needed.

It is recommended that effective contraception should be used during treatment with Hemlibra for females who are able to become pregnant.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Hemlibra crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Hemlibra.

Take Hemlibra exactly as prescribed.

Hemlibra comes in an injectable form to be given just under the skin (subcutaneously) once weekly.

Bypassing agents should be stopped the day before starting Hemlibra.

Follow your healthcare provider's instructions on how to use Hemlibra. Do not use Hemlibra unless you have been instructed by a healthcare provider and understand how to use it.

Hemlibra is injected into the thigh or the stomach at least 2 inches away from the belly button. Hemlibra can also be injected into the outer area of the arm by another person. Hemlibra should be injected into a different site each time. The site of injection should be at least 1 inch away from the last spot it was injected. Do not inject into broken skin, moles, scars, or bruises.

Only use the syringes and needles that your healthcare provider prescribes. Only use the syringes and needles one time. Throw away any used syringes and needles into a sharps container or a container that the needle can not puncture such as a milk carton.

If you miss a dose of Hemlibra on your scheduled day, take the missed dose as soon as you remember. You must give the missed dose before the next scheduled dosing day and then continue your normal weekly dosing schedule. Do not take two doses of Hemlibra at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of Hemlibra for the prevention of bleeding episodes for persons with hemophilia A (factor VIII deficiency) is based on weight. Hemlibra is injected once weekly. The initial dose will be higher than the long-term dose. After 4 weeks, a lower dose will be started.

If you take too much Hemlibra, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Hemlibra in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC). Do not freeze.
• Hemlibra should be stored in the original carton to protect the vial from light.
• Do not shake Hemlibra.
• Hemlibra should not be stored in a syringe. After Hemlibra is transferred from the vial to the syringe, it should be used right away.
• Hemlibra may affect lab tests that measure how well your blood is clotting. Tell each of your healthcare providers that you are taking Hemlibra.
• If needed for traveling, an unopened vial of Hemlibra can be stored out of the refrigerator for no more than 7 days at 86ºF (30ºC) or below.

WARNING: THROMBOTIC MICROANGIOPATHY AND THROMBOEMBOLISM

Cases of thrombotic microangiopathy and thrombotic events were reported when on average a cumulative amount of >100 U/kg/24 hours of activated prothrombin complex concentrate was administered for 24 hours or more to patients receiving HEMLIBRA prophylaxis. Monitor for the development of thrombotic microangiopathy and thrombotic events if aPCC is administered. Discontinue aPCC and suspend dosing of HEMLIBRA if symptoms occur.