A blog about research, awareness, prevention, treatment and survivorship of Breast Cancer and all cancers, including targeted scientific research and a grassroots approach to increase screening for cancer, especially in the low income and under-insured population of El Paso, Texas, with a view to expand this new health care model to many other 'minority' populations across the United States and beyond
Wednesday, September 25, 2013
just in now!
Developed under the direction and sponsorship of Bristol-Myers Squibb.
Risk Evaluation and Mitigation Strategy (REMS) for YERVOY (ipilimumab)
on the Risks of and Recommended Management for Severe Immune-mediated
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
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.
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:
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
John Tsai, MD
Vice President, Head of US Pharmaceuticals Medical
This letter is required and approved by FDA as part of the YERVOY REMS.
References: YERVOY Full Prescribing Information, 03/11 731US11REMS00101 03/11