Emicizumab-kxwh (em-i-SIZ-ue-mab - kxwh)

Prevents and decreases the frequency of bleeding in patients with hemophilia A.

Brand Name(s):

Hemlibra

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. It is usually injected into the upper outer arms, thighs, or stomach.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• Check the liquid in the vial. It should be colorless or slightly yellow. Do not use if it is cloudy, hazy, discolored, or has particles in it. Do not shake.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are tender, red, bruised, hard, or not intact, or into areas with moles or scars.
• Use a new needle and syringe each time you inject your medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. Store it in its original carton. You may store the unopened vial at room temperature if needed, and then return to the refrigerator. It should not be stored out of the refrigerator for more than 7 days. Throw away any unused medicine left in the vial.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or plan to become pregnant. Women should use an effective form of birth control to keep from getting pregnant during treatment with this medicine. If you think you have become pregnant while using this medicine, tell your doctor right away.
• Tell your doctor if you are breastfeeding, or if you have kidney disease or blood vessel problems.
• This medicine may cause the following problems:
  • Thrombotic microangiopathy (blood vessel damage)
  • Increased risk for blood clots
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, coughing up blood
• Numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg
• Sudden or severe headache, problems with vision, speech, or walking

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Joint or muscle pain
• Pain, itching, burning, redness, swelling, or a lump under your skin where the shot is given

If you notice other side effects that you think are caused by this medicine, tell your doctor

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