Note: This document contains side effect information about caplacizumab. Some dosage forms listed on this page may not apply to the brand name Cablivi.
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:
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easy bruising or bleeding (nosebleeds, bleeding gums);
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unusual vaginal bleeding;
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any bleeding that will not stop; or
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signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.
Common side effects may include:
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nosebleeds, bleeding gums; or
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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]
