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FATAL AND SERIOUS TOXICITIES: HEPATIC, SEVERE DIARRHEA, COLITIS, PNEUMONITIS, and INTESTINAL PERFORATION
- Fatal and/or serious hepatotoxicity occurred in 14% of Zydelig-treated patients. Monitor hepatic function prior to and during treatment. Interrupt and then reduce or discontinue Zydelig as recommended [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS].
- Fatal and/or serious and severe diarrhea or colitis occurred in 14% of Zydelig-treated patients. Monitor for the development of severe diarrhea or colitis. Interrupt and then reduce or discontinue Zydelig as recommended [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS].
- Fatal and serious pneumonitis can occur in Zydelig-treated patients. Monitor for pulmonary symptoms and bilateral interstitial infiltrates. Interrupt or discontinue Zydelig as recommended [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS].
- Fatal and serious intestinal perforation can occur in Zydelig-treated patients across clinical trials. Discontinue Zydelig for intestinal perforation [see WARNINGS AND PRECAUTIONS].
Idelalisib is an inhibitor of phosphatidylinositol 3-kinase, PI3Kδ.
The chemical name for idelalisib is 5-fluoro-3-phenyl-2-[(1S)-1-(9H-purin-6-ylamino)propyl]quinazolin-4(3H)-one. It has a molecular formula of C22H18FN7O and a molecular weight of 415.42 g/mol. Idelalisib has the following structural formula:
Idelalisib is a white to off-white solid with a pH-dependent aqueous solubility ranging from < 0.1 mg/mL at pH 5-7 to over 1 mg/mL at pH 2 under ambient conditions.
Zydelig (idelalisib) tablets are for oral administration. Each tablet contains either 100 mg or 150 mg of idelalisib with the following inactive ingredients: microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, sodium starch glycolate, magnesium stearate and a tablet coating. The tablet coating consists of polyethylene glycol, talc, polyvinyl alcohol, and titanium dioxide and of FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake (for the 100 mg tablet) and red iron oxide (for the 150 mg tablet).
Last reviewed on RxList: 8/1/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Zydelig Information
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