Wednesday, September 25, 2013

just in now!

Developed under the direction and sponsorship of Bristol-Myers Squibb.


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:


  • 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

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