Emicizumab

Emicizumab is used to help stop bleeding episodes or reduce how often they happen in people with hemophilia A, whether or not they have factor VIII inhibitors.

Emicizumab may also be used for reasons not mentioned in this medication guide.

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Emicizumab can change the results of some blood-clotting tests. Inform any doctor treating you that you are using emicizumab.

Emicizumab is injected under the skin, typically once every 1 to 4 weeks. A healthcare provider will give you this injection.

Doses are based on weight. Your dose may change if you gain or lose weight.

You may be able to give this injection to yourself. Ask your doctor or pharmacist if you do not understand how to administer an injection.

Your healthcare provider will show you where to inject emicizumab. Do not inject in the same spot two times in a row or into a mole, or into skin that is scarred, hard, broken, red, bruised, swollen, or tender.

Prepare an injection only when you are ready to give it. Contact your pharmacist if the medicine looks cloudy, has changed colors, or has particles in it.

Do not shake the medication bottle or you may damage the medicine. Prepare an injection only when you are ready to give it. Contact your pharmacist if the medicine looks cloudy, has changed colors, or has particles in it.

Once you open and puncture the vial (bottle), use the medicine immediately. Do not save it for later use. Dispose of a vial (bottle) after one use, even if there is still medicine left inside.

Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it according to state or local laws. Keep out of the reach of children and pets.

Store this medicine in the original carton in an upright position in the refrigerator. Protect it from light and do not freeze.

You may store an unopened vial (bottle) at room temperature for a short time. If not used within 7 days, return the vial (bottle) to the refrigerator.

Emicizumab can lead to unwanted blood clots, especially if you are also using activated prothrombin complex concentrate (aPCC), like FEIBA.

If you are using emicizumab along with a bypassing agent or factor VIII, contact your doctor immediately if you experience any of the following symptoms: weakness, confusion, stomach or back pain, vomiting, decreased urination, chest pain, difficulty breathing, coughing up blood, rapid heart rate, swelling or redness in your arms or legs, eye pain, or vision issues.

Tell your doctor if you use factor VIII or a bypassing agent. Emicizumab can cause unwanted blood clots, especially if you also use activated prothrombin complex concentrate (aPCC), such as FEIBA.

You will most likely need to stop using bypassing agents the day before you start treatment with emicizumab. However, you may continue to use factor VIII for the first week of treatment with emicizumab.

If your doctor tells you to keep using a bypassing agent, you may need to limit your dose to no more than 100 units/kilogram per 24 hours. Use only the prescribed dose and follow all instructions for safe use.

It is not known if emicizumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Both men and women using emicizumab should use effective birth control to prevent pregnancy.

Ask a doctor if it is safe to breastfeed while using this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

If you also use a bypassing agent, call your doctor right away if you have any of these side effects:

• headache, weakness, confusion;
• feeling light-headed or unusually sick;
• back pain, little or no urination;
• stomach pain, nausea, vomiting;
• chest pain, feeling short of breath, coughing up blood;
• swelling or redness in your arms or legs;
• bleeding problems;
• eye pain or swelling, vision problems;
• numbness in your face; or
• yellowing of your skin or eyes.

Common side effects of emicizumab may include:

• headache;
• joint pain; or
• pain, swelling, burning, or irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Hemophilia A with Inhibitors:

Loading dose: 3 mg/kg subcutaneously once a week for the first 4 weeksMaintenance dose: 1.5 mg/kg subcutaneously once a week, or 3 mg/kg subcutaneously once every two weeks, or 6 mg/kg subcutaneously once every four weeksComments:-Discontinue prophylactic use of bypassing agents the day before starting this drug; prophylactic use of factor VIII (FVIII) products may be continued during the first week of prophylaxis with this drug.-Maintenance dose selection should be based on provider preference with consideration given to patient adherence.Use: Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors.

Usual Pediatric Dose for Hemophilia A with Inhibitors:

Newborn or Older:Loading dose: 3 mg/kg subcutaneously once a week for the first 4 weeksMaintenance dose: 1.5 mg/kg subcutaneously once a week, or 3 mg/kg subcutaneously once every two weeks, or 6 mg/kg subcutaneously once every four weeksComments:-Discontinue prophylactic use of bypassing agents the day before starting this drug; prophylactic use of factor VIII (FVIII) products may be continued during the first week of prophylaxis with this drug.-Maintenance dose selection should be based on provider preference with consideration given to patient adherence.Use: Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in newborn or older pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors.

Use the medicine as soon as you remember, and then return to your regular schedule. Do not use two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may impact emicizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are taking.