Hemlibra is a monoclonal antibody that functions in place of a natural blood-clotting factor that is missing in people with hemophilia A. Emicizumab works as a "bridge" between other clotting factors to replace missing factor VIII.

Hemlibra is for adults and children with hemophilia A with or without factor VIII inhibitors. Hemlibra is used to help prevent bleeding episodes or make them occur less often.

Hemlibra will not stop a bleeding episode that has already begun.

Hemlibra can cause unwanted blood clots when used together with a bypassing agent such as FEIBA. This can damage small blood vessels in your arms and legs, brain, kidneys, lungs, or other organs.

Tell your doctor if you use a bypassing agent or factor VIII. You will most likely need to stop using them the day before you begin using Hemlibra.

If you use Hemlibra and a bypassing agent together, 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, swelling or redness in your arms or legs, eye pain, or vision problems.

Before taking this medicine

You should not use Hemlibra if you are allergic to emicizumab.

Tell your doctor if you use factor VIII or a bypassing agent such as FEIBA (or "aPCC"; activated prothrombin complex concentrate). Emicizumab can cause unwanted blood clots when used together with aPCC. These blood clots can damage small blood vessels in your arms and legs, brain, kidneys, lungs, or other organs.

You will most likely need to stop using bypassing agents the day before you begin using Hemlibra. But you may keep using factor VIII for the first week of using Hemlibra.

If your doctor tells you to keep using a bypassing agent, you may need to limit your emicizumab dose to more than 100 units/kilogram per 24 hours. Follow all instructions carefully.

Follow your doctor's instructions about using Hemlibra if you are pregnant. It is not known whether this medicine will harm an unborn baby. Control of bleeding episodes is very important during pregnancy. The benefit of preventing these episodes may outweigh any risks to the baby.

If you are not pregnant, use effective birth control to prevent pregnancy while using this medicine.

It is not known whether emicizumab passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Use Hemlibra exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Hemlibra is injected under the skin every 1 to 4 weeks. A healthcare provider may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

You will need a syringe and needle to draw Hemlibra out of the vial (bottle). You will need a separate needle to inject the medicine into your skin. Use only the type of syringe and needles recommended by your pharmacist to inject Hemlibra.

Do not shake the medication bottle. Prepare your dose only when you are ready to give an injection. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Do not allow a child younger than 7 years old to self-inject this medicine without help from an adult.

Hemlibra can interfere with certain blood-clotting tests. Tell any doctor who treats you that you are using emicizumab.

Store this medicine in the original carton in a 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 to the refrigerator.

Once you open and puncture the vial, use the medicine right away. Do not save it for later use. Throw away the vial after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Usual Adult Dose for Hemophilia A with Inhibitors:

3 mg/kg subcutaneously once a week for the first 4 weeks, followed by 1.5 mg/kg once a week.

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:

3 mg/kg subcutaneously once a week for the first 4 weeks, followed by 1.5 mg/kg once a week.

Use: Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors.

You should not use Hemlibra if you are allergic to emicizumab.

Tell your doctor if you use factor VIII or a bypassing agent such as FEIBA (or "aPCC"; activated prothrombin complex concentrate). Emicizumab can cause unwanted blood clots when used together with aPCC. These blood clots can damage small blood vessels in your arms and legs, brain, kidneys, lungs, or other organs.

You will most likely need to stop using bypassing agents the day before you begin using Hemlibra. But you may keep using factor VIII for the first week of using Hemlibra.

If your doctor tells you to keep using a bypassing agent, you may need to limit your emicizumab dose to more than 100 units/kilogram per 24 hours. Follow all instructions carefully.

Follow your doctor's instructions about using Hemlibra if you are pregnant. It is not known whether this medicine will harm an unborn baby. Control of bleeding episodes is very important during pregnancy. The benefit of preventing these episodes may outweigh any risks to the baby.

If you are not pregnant, use effective birth control to prevent pregnancy while using this medicine.

It is not known whether emicizumab passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Use the missed dose as soon as you remember. Then go back to your usual once-weekly schedule and use the next dose on your regular injection day. Do not use extra medicine to make up the missed dose.

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

Avoid injecting this medicine into a mole or into skin that is scarred, bruised, red, tender, hard, or broken.

Get emergency medical help if you have signs of an allergic reaction to Hemlibra : 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, vomiting;

• chest pain, feeling short of breath, coughing up blood;

• swelling or redness in your arms or legs;

• eye pain or swelling, vision problems;

• numbness in your face; or

• yellowing of your skin or eyes.

Common Hemlibra 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.

Other drugs may interact with emicizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.