<p><strong>Pediatric Use</strong>: Ospemifene is not indicated in children. Clinical studies have not been conducted in the pediatric population.<br />
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<strong>Geriatric Use</strong>: Of the 2209 Ospemifene-treated women enrolled in the ten phase 2/3 trials of Ospemifene, &gt;19 percent were 65 years of age or older. No clinically meaningful differences in safety or effectiveness were observed between these women and younger women less than 65 years of age.<br />
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<strong>Renal Impairment</strong>: The pharmacokinetics of ospemifene in women with severe renal impairment (CrCL &lt;30 mL/min) was similar to those in women with normal renal function. No dose adjustment of Ospemifene is required in women with renal impairment.<br />
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<strong>Hepatic Impairment</strong>: The pharmacokinetics of ospemifene has not been studied in women with severe hepatic impairment (Child-Pugh Class C); therefore, do not use Ospemifene in women with severe hepatic impairment.</p>