Immune-related adverse reactions

YERVOY™ is associated with inflammatory adverse reactions resulting from increased or excessive immune activity (immune-related Adverse Reactions, irARs), likely to be related to its mechanism of action. IrARs, which can be severe or life-threatening, may involve the gastrointestinal, liver, skin, nervous, endocrine, or other organ systems.1

  • While most irARs occurred during the induction period, onset months after the last dose of YERVOY™ has also been reported.1
  • Unless an alternate aetiology has been identified, signs and symptoms suggestive of irARs (diarrhoea, increased stool frequency, bloody stools, LFT elevations, rash and endocrinopathy) must be considered infl ammatory and YERVOY™-related.1
  • Early diagnosis and appropriate management are essential to minimise life-threatening complications.1
  • Systemic high-dose corticosteroid with or without additional immunosuppressive therapy may be required for management of severe irARs.1

This YERVOY™-specific Management Guide for irARs intends to aid early diagnosis and appropriate management of life-threatening complications.

Immune-related Adverse Reactions Management

  • Depending on their nature, irARs, including grade 3/4, can generally be managed with the following 3-step approach:

irar - 3-step approach

*Until administration of all 4 doses or 16 weeks from first dose, which ever occurs earlier.1
**Discontinue YERVOY™ in: severe Grade 3/4 diarrhoea or colitis (investigate for gastrointestinal perforation /peritonitis); YERVOY™-related AST/ALT >8 x ULN, bilirubin>5 x ULN; severe Grade 4 rash or severe Grade 3 pruritus; severe YERVOY™-related Grade 3/4 sensory neuropathy; severe Grade 3/4 immune-related reactions. (NCI-CTCAE v3)1


irar - do:s

Immune-related Adverse Reactions Management Guide

Although any organ system can be affected the picture below contains a schematic of the body and the organ systems from which the most common irARs can originate (e.g. gastrointestinal, skin). Corresponding pages are presented by organ system and provide guidance on how to appropriately manage the associated adverse reactions. Click on “See guidance” to enter the corresponding page for each organ.

See guidance
Signs and symptoms such as
  • Diarrhoea
  • Abdominal pain
  • Blood or mucus in stool
  • Bowel perforation
  • Peritoneal signs
  • Ileus
See guidance
Signs such as
  • Abnormal liver function tests (e.g. AST, ALTor total bilirubin)
SKIN (1)
See guidance
Symptoms such as
  • Pruritus
  • Rash

irar - overview

See guidance
Symptoms such as
  • Unilateral or bilateral weakness
  • Sensory alterations
  • Paresthesia
See guidance
Signs and symptoms such as
  • Fatigue
  • Headache
  • Mental status changes
  • Abdominal pain
  • Unusual bowel habits
  • Hypotension
  • Abnormal thyroid function tests and/or serum chemistries
OTHER ADVERSE REACTIONS (1) including ocular manifestations
See guidance

Please refer to the YERVOY™ Summary of Product Characteristics for a comprehensive description of these risks and others.  

1. YERVOY™ Summary of Product Characteristics.

Senast uppdaterad:  2015-07-02Ansvarig:  Anna Labecker