Ofev Use In Pregnancy & Lactation

Women of childbearing potential/Contraception: Nintedanib may cause foetal harm in humans (see Pharmacology: Toxicology: Preclinical Safety Data under Actions). Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with OFEV and to use highly effective contraceptive methods at the initiation of, during and at least 3 months after the last dose of OFEV. Nintedanib does not relevantly affect the plasma exposure of ethinylestradiol and levonorgestrel (see Pharmacology: Pharmacokinetics under Actions). The efficacy of oral hormonal contraceptives may be compromised by vomiting and/or diarrhoea or other conditions where the absorption may be affected. Women taking oral hormonal contraceptives experiencing these conditions should be advised to use an alternative highly effective contraceptive measure.
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 active substance (see Pharmacology: Toxicology: Preclinical Safety Data under Actions). As nintedanib may cause foetal harm also in humans, it must not be applied during pregnancy (see Contraindications) and pregnancy testing must be conducted prior to treatment with OFEV and during treatment as appropriate.
Female patients should be advised to notify their doctor or pharmacist if they become pregnant during therapy with OFEV.
If the patient becomes pregnant while receiving OFEV, treatment must be discontinued and the patient should be apprised of the potential hazard to the foetus.
Breast-feeding: 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.
Fertility: Based on preclinical investigations, there is no evidence for impairment of male fertility (see Pharmacology: Toxicology: Preclinical Safety Data 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: Preclinical Safety Data under Actions).