Treatment with CABLIVI is commonly associated with bleeding-related events such as nosebleeds and gingival bleeding, as well as headache, with a potential for more serious hemorrhage and hypersensitivity reactions.

Adverse Reaction Profile of CABLIVI

The most frequently observed adverse reactions (incidence >15%) during clinical trials with CABLIVI were epistaxis (nosebleeds), headache, and gingival bleeding. Serious bleeding adverse reactions reported included epistaxis and subarachnoid hemorrhage. Other notable adverse reactions occurring more frequently than with placebo included various forms of hemorrhage (rectal, injection site, catheter site, vaginal, hematuria), fatigue, pyrexia, urticaria, and gastrointestinal or musculoskeletal discomforts. Postmarketing experience has identified injection site reactions like pain, bruising, and erythema, and has also confirmed reports of life-threatening and fatal bleeding. While immunogenicity, including the development of treatment-emergent anti-drug antibodies with neutralizing potential, was observed in a small percentage of patients, it did not have a clinically apparent impact on efficacy or safety. Patients should be counseled on these potential side effects and monitored accordingly.