YERVOY TM (Ipilimumab) Safety Management

The YERVOY Risk Evaluation and Mitigation Strategy (REMS) is designed to inform healthcare providers about the risk of serious immune-mediated adverse reactions caused by YERVOY. In order for Bristol-Myers Squibb to communicate certain risks about YERVOY, Bristol-Myers Squibb has worked with the FDA to develop materials to communicate the risks of severe and fatal:

  • Immune-mediated enterocolitis (including gastrointestinal perforation)
  • Immune-mediated hepatitis (including hepatic failure)
  • Immune-mediated dermatitis (including toxic epidermal necrolysis)
  • Immune-mediated neuropathies
  • Immune-mediated endocrinopathies

To learn more about the serious immune-mediated adverse reactions caused by YERVOY, read the Important Safety Information provided in this link, including the Medication Guide, and discuss it with your patients.

 

Downloadable REMS Materials

Dear healthcare provider Letter

Dear healthcare provider Letter A communication to healthcare providers conveying Important Safety Information for YERVOY, including the risks of serious immune-mediated adverse reactions.
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YERVOY Immune-mediated Adverse Reaction Management Guide

YERVOY 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.
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Nursing Immune-mediated Adverse Reaction Checklist

Nursing Immune-mediated Symptom Checklist Checklist with key questions to ask patients and actions to take when assessing patients for YERVOY immune-mediated adverse reactions.

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Patient Wallet Card

Patient Wallet Card A foldable patient resource containing a list of symptoms associated with YERVOY immune-mediated adverse reactions and contact information for the patient's treating healthcare provider.
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