Emicizumab

Generic name: emicizumab [ EM-i-SIZ-ue-mab ]
Brand names: Hemlibra, Hemlibra 105 mg/0.7 mL, Hemlibra 60 mg/0.4 mL, Hemlibra 12 mg/0.4 mL
Dosage form: subcutaneous solution (kxwh 105 mg/0.7 mL; kxwh 12 mg/0.4 mL; kxwh 150 mg/mL; kxwh 30 mg/mL; kxwh 300 mg/2 mL; kxwh 60 mg/0.4 mL)
Drug class: Miscellaneous coagulation modifiers

Medically reviewed by Drugs.com on Aug 6, 2024. Written by Cerner Multum.

What is emicizumab?

Emicizumab is used to help prevent bleeding episodes or make them occur less often in people with hemophilia A, with or without factor VIII inhibitors.

Emicizumab may also be used for purposes not listed in this medication guide.

Emicizumab side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult 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.

Warnings

Emicizumab can cause unwanted blood clots, especially if you also use activated prothrombin complex concentrate (aPCC), such as FEIBA.

If you use emicizumab together with a bypassing agent or factor VIII, call your doctor at once if you have any of these symptoms: weakness, confusion, stomach or back pain, vomiting, decreased urination, chest pain, trouble breathing, coughing up blood, fast heart rate, swelling or redness in your arms or legs, eye pain, or vision problems.

Before taking this medicine

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 begin treatment with emicizumab. But you may keep using 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.

How is emicizumab given?

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

Emicizumab can affect the results of certain blood-clotting tests. Tell any doctor who treats you that you are using emicizumab.

Emicizumab is injected under the skin, usually 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 don't understand how to use an injection.

Your healthcare provider will show you where to inject emicizumab. Do not inject into the same place 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. Call your pharmacist if the medicine looks cloudy, has changed colors, or has particles in it.

Do not shake the medication bottle or you may ruin the medicine. Prepare an injection only when you are ready to give it. Call 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 right away. Do not save it for later use. Throw away 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 following 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 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 dosing information

Usual Adult Dose for Hemophilia A with Inhibitors:

Loading dose: 3 mg/kg subcutaneously once a week for the first 4 weeks

Maintenance 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 weeks

Comments:
-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 weeks

Maintenance 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 weeks

Comments:
-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.

Related/similar drugs

tranexamic acid, desmopressin, Cyklokapron, DDAVP, Humate-P, Hemlibra

What happens if I miss a dose?

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

What happens if I overdose?

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

What should I avoid while using emicizumab?

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

What other drugs will affect emicizumab?

Other drugs may affect emicizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Emicizumab Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for emicizumab.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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