Ipilimumab (Yervoy, Bristol-Myers Squibb) is an anti–CTLA-4 monoclonal antibody approved for the treatment of unresectable or metastatic melanoma, or cutaneous melanoma with lymph node involvement. The drug is administered via IV infusion. The common adverse reactions, warnings and precautions, drug interactions and other contraindications associated with ipilimumab therapy are outlined in this section.
Topics Covered:
Common adverse reactions
Warnings and precautions
Drug interactions and other contraindications
Ipilimumab common adverse reactions
Adverse reactions occurring in at least 5% of patients in ipilimumab clinical trials included fatigue, diarrhea, pruritus, rash and colitis. Patients who received a higher dose of ipilimumab reported nausea, vomiting, headache, weight loss, fever, loss of appetite and insomnia.
Ipilimumab warnings and precautions
Severe and sometimes fatal cases of immune-mediated enterocolitis have been reported in patients receiving ipilimumab. Signs and symptoms include diarrhea, abdominal pain, blood and/or mucus in the stool and fever. Bowel perforation may occur in serious cases of enterocolitis. Patients suspected of having noninfectious enterocolitis should be evaluated endoscopically, and ipilimumab therapy should be discontinued; supportive treatment should include corticosteroids.
Other immune-mediated adverse events reported in association with ipilimumab therapy include:
- hepatitis;
- dermatologic reactions, including rash, pruritus and severe mucocutaneous reactions such as SJS and TEN;
- neuropathies, including unilateral or bilateral weakness, paresthesia and progressive weakness (Guillain-Barré-like syndrome); and
- endocrinopathies, including hypophysitis (inflammation of the pituitary gland), hyperthyroidism, hypothyroidism and adrenal insufficiency.
Ipilimumab drug interactions and other contraindications
Liver function should be assessed before each dose of ipilimumab is administered. Additionally, female patients of childbearing age should be counseled to use contraception during and for 3 months after treatment.
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