Note: This document contains side effect information about emicizumab. Some dosage forms listed on this page may not apply to the brand name Hemlibra.
Applies to emicizumab: subcutaneous solution.
Warning
Subcutaneous route (Solution)
Warning: Thrombotic Microangiopathy and ThromboembolismCases 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.
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
Other 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
- 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
For Healthcare Professionals
Applies to emicizumab: subcutaneous solution.
General
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]
