YERVOY

GASTROINTESTINAL

Immune-related enterocolitis1

gastrointestinal

  • YERVOY™ is associated with serious immune-related gastrointestinal reactions. Fatalities due to gastrointestinal perforation have been reported in clinical trials
  • Advise patients to immediately report changes in bowel movements
  • Monitor patients for gastrointestinal signs and symptoms that may be indicative of immune-related colitis or gastrointestinal perforation
  • Clinical presentation may include diarrhoea, increased frequency of bowel movements, abdominal pain, or haematochezia, with or without fever
  • Withhold YERVOY™ in patients with moderate diarrhoea or colitis that either is not controlled with medical management or that persists (5-7 days) or recurs
  • Permanently discontinue YERVOY™ in patients with severe symptoms (abdominal pain, severe diarrhoea or significant change in the number of stools, blood in stool, gastrointestinal haemorrhage, gastrointestinal perforation)
  • Corticosteroid therapy may be required.

gastrointestinal

gastrointestinal

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1. YERVOY™ Summary of Product Characteristics.

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