Hemlibra

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. You will most likely need to stop using it 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.

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

Tell your doctor if you use a bypassing agent such as FEIBA (or "aPCC"; activated prothrombin complex concentrate). Hemlibra 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. You may need to limit your dose to more than 100 units/kilogram per 24 hours if your doctor tells you to keep using a bypassing agent during treatment with this medicine. 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 Hemlibra passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

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, once per week. You may be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and syringes.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

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 this medicine.

Your care provider will show you the best places on your body to inject Hemlibra. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

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 this medicine.

Store this medicine in the original carton in a refrigerator, 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 it away after one use, even if there is still medicine left inside.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

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.

Data not available

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. US FDA pregnancy category: Not assigned. Risk Summary: No data exist to inform a drug-associated risk of major birth defects and miscarriage. Comments: Women of childbearing potential should use contraception while receiving this drug.

Animal studies have not been reported. There are no controlled data in human pregnancy. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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

Tell your doctor if you use 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. You may need to limit your dose to more than 100 units/kilogram per 24 hours if your doctor tells you to keep using a bypassing agent during treatment with Hemlibra. 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.

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

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

Copyright 1996-2018 Cerner Multum, Inc. Version: 1.01.

Medical Disclaimer

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

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.