"The U.S. Food and Drug Administration today approved Zydelig (idelalisib) to treat patients with three types of blood cancers.
Zydelig is being granted traditional approval to treat patients whose chronic lymphocytic leukemia (CLL) has retu"...
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
Report Problems to the Food and Drug Administration
Find out what women really need.