<p><strong>Pediatric Use</strong>: The safety and effectiveness of Regorafenib in pediatric patients less than 18 years have not been established.<br />
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<strong>Geriatric Use</strong>: No overall differences in safety or effectiveness were observed between adult subjects and younger subjects.<br />
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<strong>Hepatic Impairment</strong>: No clinically important differences in the mean exposure of regorafenib or the active metabolites M-2 and M-5 were observed in patients with hepatocellular carcinoma and mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment compared to patients with normal hepatic function. No dose adjustment is recommended in patients with mild or moderate hepatic impairment. Closely monitor patients with hepatic impairment for adverse reactions. Regorafenib is not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C) as it has not been studied in this population.<br />
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<strong>Renal Impairment</strong>: No dose adjustment is recommended for patients with mild renal impairment. Limited pharmacokinetic data are available from patients with moderate renal impairment (CLcr 30-59 mL/min/1.73m2). Regorafenib has not been studied in patients with severe renal impairment or end-stage renal disease.<br />
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<strong>Females and Males of Reproductive Potential</strong>: Contraception: Use effective contraception during treatment and up to 2 months after completion of therapy.<br />
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<strong>Infertility</strong>: There are no data on the effect of regorafenib on human fertility. Results from animal studies indicate that regorafenib can impair male and female fertility</p>