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Caplacizumab Side Effects

Medically reviewed by Drugs.com. Last updated on Apr 7, 2021.

For the Consumer

Applies to caplacizumab: injectable kit

Warning

Caplacizumab can increase your risk of bleeding. Call your doctor if you have unusual bruising or bleeding, or any bleeding that will not stop.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • easy bruising or bleeding (nosebleeds, bleeding gums);

  • unusual vaginal bleeding;

  • any bleeding that will not stop; or

  • signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common side effects may include:

  • nosebleeds, bleeding gums; or

  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to caplacizumab: injectable kit

General

The most frequently reported adverse reactions were epistaxis, headache, and gingival bleeding.[Ref]

Respiratory

Very common (10% or more): Epistaxis (29%)

Common (1% to 10%): Dyspnea, hemoptysis[Ref]

Nervous system

Very common (10% or more): Headache (21%), paresthesia (12%)

Common (1% to 10%): Subarachnoid hemorrhage, cerebral infarction[Ref]

Gastrointestinal

Very common (10% or more): Gingival bleeding (16%)

Common (1% to 10%): Upper GI hemorrhage, rectal hemorrhage, abdominal wall hematoma[Ref]

Immunologic

Very common (10% or more): Pre-existing antibodies binding to this drug (63%)

Common (1% to 10%): Treatment-emergent antibodies against this drug[Ref]

Cardiovascular

Very common (10% or more): Bleeding events (58%)[Ref]

Other

Very common (10% or more): Fatigue (15%), pyrexia (13%)[Ref]

Dermatologic

Very common (10% or more): Urticaria (14%)[Ref]

Genitourinary

Common (1% to 10%): Metrorrhagia, urinary tract infection, vaginal hemorrhage, hematuria, menorrhagia[Ref]

Local

Common (1% to 10%): Injection site hemorrhage, catheter site hemorrhage, injection site pruritus[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, myalgia[Ref]

Ocular

Common (1% to 10%): Eye hemorrhage[Ref]

References

1. "Product Information. Cablivi (caplacizumab)." Genzyme Corporation, Cambridge, MA.

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.