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Cablivi Side Effects

Generic Name: caplacizumab

Medically reviewed by Drugs.com. Last updated on Nov 13, 2020.

Note: This document contains side effect information about caplacizumab. Some of the dosage forms listed on this page may not apply to the brand name Cablivi.

For the Consumer

Applies to caplacizumab: injection kit

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
  • Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
  • A burning, numbness, or tingling feeling that is not normal.
  • Shortness of breath.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

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.