Applies to caplacizumab: injectable kit.

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]