April 08, 2011
SAFETY ALERT: Risk Evaluation and Mitigation Strategy (REMS) for YervoyBristol-Myers Squibb informed healthcare professionals about the Risk Evaluation and Mitigation Strategy (REMS), developed in collaboration with the FDA, that is required to ensure that the benefits of Yervoy (ipilimumab) outweigh the risks of severe and fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of Yervoy.
Healthcare providers are advised to read the Boxed Warning and accompanying full Prescribing Information for a complete description of these risks and their management and are advised to discuss the risks that may be associated with therapy with patients and their caregivers. Clinicians are advised to:
- Permanently discontinue Yervoy and initiate systemic high-dose corticosteroid therapy for identified severe immune-mediated reactions
- Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy and endocrinopathy and evaluate clinical chemistries, including liver function tests and thyroid function tests, at baseline and before each dose
Yervoy is indicated for the treatment of late-stage (metastatic) melanoma.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm249770.htm.