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	Subject: Risk Evaluation and Mitigation Strategy (REMS) for  YERVOY (ipilimumab) on the Risks of and Recommended  Management for Severe Immune-mediated Adverse Reactions Dear Healthcare Provider: This letter is intended to inform you about the risk evaluation and  mitigation strategy (REMS), developed by Bristol-Myers Squibb  in collaboration with FDA, that is required to ensure that the  benefits of YERVOY outweigh the risks of severe and fatal  immune-mediated adverse reactions. The YERVOY full Prescribing Information includes the following  Boxed Warning: WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS YERVOY can result in severe and fatal immune-mediated  adverse reactions due to T-cell activation and proliferation.  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. Permanently discontinue YERVOY and initiate systemic  high dose corticosteroid therapy for severe immune-mediated  reactions. [See Dosage and Administration (2.2)] 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. [See Warnings  and Precautions (5.1, 5.2, 5.3, 5.4, 5.5)] This letter is not a comprehensive description of the risks associated with  the use of YERVOY. The Boxed Warning summarizes the most common  and severe immune-mediated adverse reactions. Healthcare providers  must read the boxed warning and accompanying full Prescribing Information   for a complete description of these risks and their management.   You are advised to discuss the risks that may be associated with  YERVOY therapy with patients and their caregivers. The YERVOY  patient Medication Guide contains information about the known and  potential risks of YERVOY. REMS OVERVIEW The YERVOY REMS consists of a Communication Plan to inform  Healthcare Providers of the serious risks of YERVOY, to facilitate  early identification of these risks, and an overview of recommended  management of patients with moderate or more severe immune-mediated  adverse reactions. Bristol-Myers Squibb will make available this  Dear Healthcare Provider Letter and the following communication  plan materials in print, electronic and web-based formats: Immune-mediated Adverse Reaction Management Guide A booklet designed to inform healthcare providers of the  signs, symptoms and management of YERVOY  immune-mediated adverse reactions Nursing Immune-mediated Adverse Reaction Checklist A checklist with key questions to ask patients and actions  to take when assessing patients for YERVOY immune-mediated  adverse reactions Patient Wallet Card A foldable patient resource containing a list of symptoms   associated with YERVOY adverse reactions and contact  information for the patient's prescribing healthcare provider For additional information regarding YERVOY or additional copies of  the YERVOY REMS materials you may: •  Call the Bristol-Myers Squibb toll-free medical information line at 1-800-321-1335 •  Visit the YERVOY web site at www.YERVOY.com/hcp/rems REPORTING ADVERSE REACTIONS Healthcare providers should report all suspected adverse reactions associated with the use of YERVOY. Please contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Sincerely, John Tsai, MD Vice President, Head of US Pharmaceuticals Medical Bristol-Myers Squibb This letter is required and approved by FDA as part of the YERVOY REMS. References: YERVOY Full Prescribing Information, 03/11 731US11REMS00101 03/11