<p><strong>Females</strong>: Ceritinib can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should be advised to use effective contraception during treatment with Ceritinib and for 6 months following completion of therapy.<br />
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<strong>Males</strong>: Based on the potential for genotoxicity, males with female partners of reproductive potential should be advised to use condoms during treatment with Ceritinib and for 3 months following completion of therapy.<br />
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<strong>Pediatric Use</strong>: The safety and effectiveness of Ceritinib in pediatric patients have not been established.<br />
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<strong>Geriatric Use</strong>: Of the 925 patients in clinical studies of Ceritinib, 18% were 65 years or older, while 5% were 75 years or older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.<br />
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<strong>Hepatic Impairment</strong>: For patients with severe hepatic impairment (Child-Pugh C), the dose of Ceritinib should be reduced by approximately one-third, rounded to the nearest multiple of the 150 mg dosage strength. No dose adjustment is recommended in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment.</p>