Hemlibra Side Effects
Generic name: emicizumab
Medically reviewed by Drugs.com. Last updated on May 11, 2024.
Note: This document provides detailed information about Hemlibra Side Effects associated with emicizumab. Some dosage forms listed on this page may not apply specifically to the brand name Hemlibra.
Applies to emicizumab: subcutaneous solution.
Important warnings
This medicine can cause some serious health issues
Subcutaneous route (solution)
Warning: Thrombotic Microangiopathy and Thromboembolism. Cases of thrombotic microangiopathy and thrombotic events were reported when on average a cumulative amount of greater than 100 units/kg/24 hours of activated prothrombin complex concentrate was administered for 24 hours or more to patients receiving emicizumab-kxwh prophylaxis.
Monitor for the development of thrombotic microangiopathy and thrombotic events if aPCC is administered.
Discontinue aPCC and suspend dosing of emicizumab-kxwh if symptoms occur.
Precautions
It is very important that your doctor check your progress closely at regular visits while you or your child are receiving this medicine to make sure it is working properly. Blood tests will be needed to check for unwanted effects.
Thrombotic microangiopathy (damage in the smallest blood vessels) may occur while you are using this medicine. Tell your doctor right away if you have the following symptoms: a fever, tiredness, confusion, loss of vision, or seizures.
This medicine may increase your chance of having blood clotting problems. Tell your doctor right away if you have a sudden or severe headache, problems with vision or speech, chest pain, shortness of breath, or numbness or weakness while you are receiving this medicine.
Using this medicine while you are pregnant can harm your unborn baby. Women should use an effective form of birth control to keep from getting pregnant during treatment with this medicine. If you think you have become pregnant while using this medicine, tell your doctor right away.
Tell your doctor if this medicine does not prevent or stop bleeding as expected.
Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days or months before you have surgery or medical tests.
Common side effects of Hemlibra
Some side effects of emicizumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common side effects
- bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- headache
- diarrhea
- difficulty in moving
- fever
- joint pain or swelling
- muscle aches, cramps, pain, or stiffness
- muscle pain or stiffness
Serious side effects of Hemlibra
Along with its needed effects, emicizumab (the active ingredient contained in Hemlibra) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking emicizumab:
Incidence not known
- blue-green to black skin discoloration
- changes in skin color, pain, tenderness, or swelling of the foot or leg
- pain, redness, or sloughing of the skin at the injection site
- sudden weakness in the arms or legs
- sudden, severe chest pain
For healthcare professionals
Applies to emicizumab: subcutaneous solution.
General adverse events
The most common adverse reactions were injection site reactions, antibody formation, headache, injection site erythema, and arthralgia.[Ref]
Cardiovascular
- Common (1% to 10%): Thrombotic microangiopathy, thrombotic events
- Frequency not reported: Superficial thrombophlebitis[Ref]
Local
- Very common (10% or more): Injection site reactions (22%), injection site erythema (11%)
- Common (1% to 10%): Injection site pain, injection site pruritus[Ref]
Nervous system
- Very common (10% or more): Headache (15%)[Ref]
Musculoskeletal
- Very common (10% or more): Arthralgia (10%)
- Common (1% to 10%): Myalgia
- Uncommon (0.1% to 1%): Rhabdomyolysis, serum creatine kinase elevated[Ref]
Gastrointestinal
- Common (1% to 10%): Diarrhea[Ref]
Immunologic
- Very common (10% or more): Antibody formation (up to 22%)[Ref]
Other
- Common (1% to 10%): Pyrexia[Ref]
Dermatologic
- Frequency not reported: Skin necrosis[Ref]
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References
1. (2017) "Product Information. Hemlibra (emicizumab)." Genentech
More about Hemlibra (emicizumab)
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Further information
Hemlibra side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.