S:9.5”
ZYDELIG® (idelalisib) tablets, for oral use
Brief Summary of full Prescribing Information. See full Prescribing
Information. Rx Only.
WARNING: 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 ZYDELIGtreated patients. Discontinue ZYDELIG for intestinal perforation
[See Warnings and Precautions].
INDICATIONS AND USAGE:
• ZYDELIG is indicated in combination with rituximab for the treatment
of adults with relapsed chronic lymphocytic leukemia (CLL) for
whom rituximab alone would be considered appropriate therapy due
to other comorbidities.
• ZYDELIG is indicated for the treatment of adults with relapsed
follicular B-cell non-Hodgkin lymphoma (FL) who have received ≥2
prior systemic therapies.
• ZYDELIG is indicated for the treatment of adults with relapsed
small lymphocytic lymphoma (SLL) who have received ≥2 prior
systemic therapies.
• Accelerated approval was granted for FL and SLL based on overall
response rate. An 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.
See Warnings and Precautions, Adverse Reactions, and Use in Specific
Populations for additional information.
Adult Starting Dose: One 150 mg tablet taken orally twice daily (BID),
swallowed whole with or without food. Continue treatment until disease
progression or unacceptable toxicity. The optimal and safe dosing regimen
for patients who required treatment longer than several months is unknown.
Severe diarrhea or colitis (≥Grade 3) occurred in 14% of ZYDELIG-treated
patients across clinical trials. ZYDELIG-induced diarrhea can occur at any
time and responds poorly to antimotility agents. Median time to resolution
ranged between 1 week and 1 month following ZYDELIG interruption with
or without enteric or systemic corticosteroids. Avoid concurrent use of
ZYDELIG with drugs that cause diarrhea. [See Dosage and Administration].
Fatal and serious pneumonitis occurred in ZYDELIG-treated patients.
Patients taking ZYDELIG who present with pulmonary symptoms
(e.g., cough, dyspnea, hypoxia, interstitial infiltrates, >5% decrease in
oxygen saturation) should be evaluated for pneumonitis. If pneumonitis is
suspected, withhold ZYDELIG until etiology of pulmonary symptoms has
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