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Emicizumab Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 4, 2020.

For the Consumer

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.

Side effects requiring immediate medical attention

Along with its needed effects, emicizumab 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

Side effects not requiring immediate medical attention

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]

References

1. "Product Information. Hemlibra (emicizumab)." Genentech, South San Francisco, CA.

Further information

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

Some side effects may not be reported. You may report them to the FDA.