<p><strong>Pediatric Use</strong>: The safety and effectiveness of Ibrutinib in pediatric patients has not been established.<br />
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<strong>Geriatric Use</strong>: Of the 905 patients in clinical studies of Ibrutinib, 62% were &ge; 65 years of age, while 21% were &ge;75 years of age. No overall differences in effectiveness were observed between younger and older patients. Anemia (all grades) and Grade 3 or higher pneumonia occurred more frequently among older patients treated with Ibrutinib.<br />
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<strong>Hepatic Impairment</strong>: Ibrutinib is metabolized in the liver. In a hepatic impairment study, data showed an increase in Ibrutinib exposure. The safety of Ibrutinib has not been evaluated in cancer patients with mild to severe hepatic impairment by Child-Pugh criteria. Monitor patients for signs of Ibrutinib toxicity and follow dose modification guidance as needed. It is not recommended to administer Ibrutinib to patients with moderate or severe hepatic impairment.</p>