Idelalisib

DEA Class; Rx

Common Brand Names; Zydelig

• Antineoplastics, PI3K Inhibitors

Indicated, in combination with rituximab, for relapsed chronic lymphocytic leukemia (CLL) in patients for whom rituximab alone would be considered appropriate therapy due to other comorbidities

Also indicated for

• Follicular B-cell Non-Hodgkin Lymphoma
• Small Lymphocytic Lymphoma

History of serious allergic reactions including anaphylaxis and history of toxic epidermal necrolysis

• Decreased ANC, Grade 3-4 (37%)
• Pyrexia (3-35%)
• Neutropenia, Grade 3 or 4 (31%)
• Nausea (27%)
• Pneumonia (16-23%)
• Chills (2-21%)
• Diarrhea, any grade (32%)
• Diarrhea or colitis, >Grade 3 (14-19%)
• Increased lymphocyte count, Grade 3-4 (18%)
• Rash (4-18%)
• Hepatotoxicity, fatal/serious (14%)
• Vomiting (13%)
• Hypoglycemia, any grade (11%)
• Pneumonia, Grade ≥3 (16%)
• Diarrhea, Grade ≥3 (14%)
• ANC decreased, Grade 3-4 (11-14%)
• ALT increased, Grade 3-4 (5-14%)

Fatal and serious pneumonitis reported; evaluate patients with pulmonary symptoms (eg, cough, dyspnea, hypoxia, interstitial infiltrates on a radiologic examination, or oxygen saturation decline of >5%); if symptomatic pneumonitis or organizing pneumonia is diagnosed, initiate appropriate treatment with corticosteroids and permanently discontinue therapy

There are no available data in pregnant women to inform the drug-associated risk In animal reproduction studies, administration of idelalisib to pregnant rats during organogenesis resulted in decreased fetal weight and congenital malformations in rats at maternal exposures (AUC) 12 times those reported in patients at the recommended dose of 150 mg twice daily

No data are available regarding the presence of idelalisib or its metabolites in human milk or its effects on the breastfed child or on milk production

Idelalisib 

tablet

• 100mg
• 150mg