<p>Women of childbearing potential/Contraception: Nintedanib may cause foetalharm in humans. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with Nintedanib. They should be advised to use adequate contraception during and at least 3 months after the last dose of Nintedanib. Since the effect of Nintedanib on the metabolism and efficacy of hormonal contraceptives has not been investigated, barrier methods should be applied as a second form of contraception, to avoid pregnancy.<br />
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<strong>Pregnancy</strong>: There is no information on the use of Nintedanib in pregnant women, but pre-clinical studies in animals have shown reproductive toxicity of this active substance. As Nintedanib may cause foetal harm also in humans, it must not be used during pregnancy. Female patients should be advised to notify their doctor or pharmacist if they become pregnant during therapy with Nintedanib. If the patient becomes pregnant while receiving Nintedanib, she should be apprised of the potential hazard to the foetus. Termination of the treatment with Nintedanib should be considered.<br />
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<strong>Lactation</strong>: There is no information on the excretion of Nintedanib and its metabolites in human milk. Pre-clinical studies showed that small amounts of Nintedanib and its metabolites (&le; 0.5% of the administered dose) were secreted into milk of lactating rats. A risk to the newborns/infants cannot be excluded. Breast-feeding should be discontinued during treatment with Nintedanib.<br />
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<strong>Fertility</strong>: Based on preclinical investigations there is no evidence for impairment of male fertility. From subchronic and chronic toxicity studies, there is no evidence that female fertility in rats is impaired at a systemic exposure level comparable with that at the maximum recommended human dose (MRHD) of 150 mg twice daily.</p>