These highlights do not include all the information needed to use ZYDELIG safely and effectively. See full prescribing information for ZYDELIG.
ZYDELIG® (idelalisib) tablets, for oral use
Initial U.S. Approval: 2014
WARNING: FATAL AND SERIOUS TOXICITIES: HEPATIC, SEVERE DIARRHEA, COLITIS, PNEUMONITIS, and INTESTINAL PERFORATION
See full prescribing information for complete boxed warning.
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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. (5.1)
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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. (5.2)
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Fatal and serious pneumonitis can occur in Zydelig-treated patients. Monitor for pulmonary symptoms and bilateral interstitial infiltrates. Interrupt or discontinue Zydelig. (5.3)
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Fatal and serious intestinal perforation can occur in Zydelig-treated patients across clinical trials. Discontinue Zydelig if intestinal perforation is suspected. (5.4)
INDICATIONS AND USAGE
Zydelig is a kinase inhibitor indicated for the treatment of patients with:
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Relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities. (1.1)
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Relapsed follicular B-cell non-Hodgkin lymphoma (FL) in patients who have received at least two prior systemic therapies. (1.2)
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Relapsed small lymphocytic lymphoma (SLL) in patients who have received at least two prior systemic therapies. (1.3)
Accelerated approval was granted for FL and SLL based on overall response rate. Improvement in patient survival or disease related symptoms has not been established. Continued approval for these indications may be contingent upon verification of clinical benefit in confirmatory trials.
DOSAGE AND ADMINISTRATION
Recommended starting dose: 150 mg orally, twice daily. (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets: 150 mg, 100 mg. (3)
CONTRAINDICATIONS
History of serious allergic reactions including anaphylaxis and toxic epidermal necrolysis. (4)
WARNINGS AND PRECAUTIONS
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Severe cutaneous reactions: Monitor patients for the development of severe cutaneous reactions and discontinue Zydelig. (5.5)
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Anaphylaxis: Monitor patients for anaphylaxis and discontinue Zydelig. (5.6)
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Neutropenia: monitor blood counts. (5.7)
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Embryo-fetal toxicity: may cause fetal harm. Advise women of potential risk to a fetus and to avoid pregnancy while taking Zydelig. (5.8)
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥20%) are diarrhea, pyrexia, fatigue, nausea, cough, pneumonia, abdominal pain, chills, and rash (6.1).
The most common laboratory abnormalities (incidence ≥30%) are neutropenia, hypertriglyceridemia, hyperglycemia, ALT elevations, and AST elevations (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
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CYP3A inducers: Avoid coadministration of strong CYP3A inducers with Zydelig. (7.1)
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CYP3A substrates: Avoid coadministration of CYP3A substrates with Zydelig. (7.2)
USE IN SPECIFIC POPULATIONS
Nursing mothers: Discontinue drug or nursing. (8.3)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 7/2014
