Ofev Use In Pregnancy & Lactation

Fertility: Based on preclinical investigations, there is no evidence for impairment of male fertility (see Pharmacology: Toxicology under Actions). 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 (see Pharmacology: Toxicology under Actions).
Contraception: Women of childbearing potential being treated with Ofev should be advised to use adequate contraception during and at least 3 months after the last dose of Ofev. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with Ofev.
Pregnancy: There is no information on the use of Ofev in pregnant women, but pre-clinical studies in animals have shown reproductive toxicity of this drug (see Pharmacology: Toxicology under Actions). As nintedanib may cause foetal harm also in humans, it must not be applied during pregnancy and pregnancy testing should be conducted at least prior to treatment with Ofev.
Female patients should be advised to notify their doctor or pharmacist if becoming pregnant during therapy with Ofev.
If the patient becomes pregnant while receiving Ofev the patient should be apprised of the potential hazard to the foetus. Termination of the treatment should be considered.
Breastfeeding/lactation: 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 (≤0.5 % of the administered dose) were secreted into milk of lactating rats.
A risk to the newborns/infants cannot be excluded. Breastfeeding should be discontinued during treatment with Ofev.