Management of adverse events associated with idelalisib treatment: Expert panel opinion Review uri icon

Overview

MeSH Major

  • Antineoplastic Agents
  • Drug-Related Side Effects and Adverse Reactions
  • Enzyme Inhibitors
  • Purines
  • Quinazolinones

abstract

  • Idelalisib is a first-in-class selective, oral, phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor approved for the treatment of several types of blood cancer. Idelalisib has demonstrated significant efficacy and a tolerable safety profile in clinical trials. However, the US prescribing information contains a black box warning for fatal and/or severe diarrhea or colitis, hepatotoxicity, pneumonitis and intestinal perforation. An expert panel was convened to review the pathology of these treatment-emergent adverse events (TEAEs) to propose key management tools for patients receiving idelalisib therapy. This article provides an overview of idelalisib TEAEs reported in clinical trials, and a summary of the panel's recommendations for identification and management of idelalisib treatment-emergent diarrhea or colitis as well as a discussion of transaminitis and pneumonitis. For idelalisib-related diarrhea or colitis (including unresolved grade 2 and grade ≥ 3), after exclusion of infectious causes, the panel recommends individualized treatment with budesonide or oral or intravenous steroid therapy.

publication date

  • January 2015

Research

keywords

  • Review

Identity

Language

  • eng

PubMed Central ID

  • PMC4732460

Digital Object Identifier (DOI)

  • 10.3109/10428194.2015.1022770

PubMed ID

  • 25726955

Additional Document Info

start page

  • 2779

end page

  • 86

volume

  • 56

number

  • 10