May 22, 2017
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Zydelig

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Zydelig

ZYDELIG®
(idelalisib) Tablets

WARNING

FATAL AND SERIOUS TOXICITIES: HEPATIC, SEVERE DIARRHEA, COLITIS, PNEUMONITIS, INFECTIONS, and INTESTINAL PERFORATION

  • Fatal and/or serious hepatotoxicity occurred in 11 to 18% 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% to 19% 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/or serious pneumonitis occurred in 4% of 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/or serious infections occurred in 21% to 36% of Zydelig-treated patients. Monitor for signs and symptoms of infection. Interrupt Zydelig if infection is suspected [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].

DRUG DESCRIPTION

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:

ZYDELIG® (idelalisib) Structural Formula Illustration

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: 11/28/2016
This monograph has been modified to include the generic and brand name in many instances.

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