Hemlibra (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.
uses
What is Hemlibra (Emicizumab) used for?
- Hemophilia A with Inhibitors
warnings
What is the most important information I should know about Hemlibra (Emicizumab)?
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 this medicine should use effective birth control to prevent pregnancy.
Ask a doctor if it is safe to breastfeed while using this medicine.
Side Effects
What are the side effects of Hemlibra (Emicizumab)?
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 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.
Pregnancy & Breastfeeding
Can I take Hemlibra (Emicizumab) if I’m pregnant or breastfeeding?
It is not known if emicizumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Ask a doctor if it is safe to breastfeed while using this medicine.
Interactions
What drugs and food should I avoid while taking Hemlibra (Emicizumab)?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Dosage Guidelines & Tips
How to take Hemlibra (Emicizumab)?
Use Hemlibra (Emicizumab) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
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.
Use the medicine as soon as you remember, and then go back to your regular schedule. Do not use two doses at one time.