Format

Send to

Choose Destination
Leuk Lymphoma. 2015;56(10):2779-86. doi: 10.3109/10428194.2015.1022770. Epub 2015 May 19.

Management of adverse events associated with idelalisib treatment: expert panel opinion.

Author information

1
a Stanford Cancer Institute, Stanford University School of Medicine , Stanford , CA , USA.
2
b Hofstra North Shore-LIJ School of Medicine , New Hyde Park , NY , USA.
3
c CLL Center, Dana Farber Cancer Institute, Harvard School of Medicine , Boston , MA , USA.
4
d Department of Medicine Hematology/Oncology , David Geffen School of Medicine at UCLA , Santa Monica , CA , USA.
5
e Weill Cornell Medical College , New York , NY , USA.
6
f UC Irvine Medical Center , Orange , CA , USA.
7
g Gilead Sciences, Inc. , Seattle , WA , USA.
8
h Swedish Cancer Institute Hematologic Malignancies Program, Swedish Medical Group , Seattle , WA , USA.
9
i Division of Gastroenterology, Duke University Medical Center , Durham , NC , USA.
10
j Willamette Valley Cancer Institute, The US Oncology Network , Eugene , OR , USA.
11
k Gilead Sciences, Inc. , Foster City , CA , USA.
12
l Medical Informatics, Department of Medicine , Memorial Sloan-Kettering Cancer Center , New York , NY , USA.

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.

KEYWORDS:

Idelalisib; colitis; diarrhea; phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor; pneumonitis; transaminitis

PMID:
25726955
PMCID:
PMC4732460
DOI:
10.3109/10428194.2015.1022770
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Taylor & Francis Icon for PubMed Central
Loading ...
Support Center