<p><strong>Elderly patients (&ge;65 years)</strong>: No overall differences in safety and efficacy were observed for elderly patients. No a-priori dose adjustment is required on the basis of a patient&rsquo;s age. Patients &ge;75 years may be more likely to require dose reduction to manage adverse effects.<br />
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<strong>Renal impairment</strong>: Less than 1% of a single dose of Nintedanib is excreted via the kidney. Adjustment of the starting dose in patients with mild to moderate renal impairment is not required. The safety, efficacy, and pharmacokinetics of Nintedanib have not been studied in patients with severe renal impairment (&lt;30 ml/min creatinine clearance).<br />
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<strong>Hepatic impairment</strong>: Nintedanib is predominantly eliminated via biliary/faecal excretion (&gt; 90%). Exposure increased in patients with hepatic impairment (Child Pugh A, Child Pugh B). In patients with mild hepatic impairment (Child Pugh A), the recommended dose of Nintedanib is 100 mg twice daily approximately 12 hours apart. In patients with mild hepatic impairment (Child Pugh A), treatment interruption or discontinuation for management of adverse reactions should be considered. The safety and efficacy of Nintedanib have not been investigated in patients with hepatic impairment classified as Child Pugh B and C. Treatment of patients with moderate (Child Pugh B) and severe (Child Pugh C) hepatic impairment with Nintedanib is not recommended.<br />
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<strong>Paediatric population</strong>:&nbsp;The safety and efficacy of Nintedanib in children aged 0-18 years have not been established. No data are available.</p>