Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

Women of childbearing potential / Contraception
Nintedanib may cause foetal harm in humans (see section 5.3). Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with Vargatef and to use highly effective contraceptive methods at initiation of, during and at least 3 months after the last dose of Vargatef. Nintedanib does not relevantly affect the plasma exposure of ethinylestradiol and levonorgestrel (see section 5.2). 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 Vargatef in pregnant women, but pre-clinical studies in animals have shown reproductive toxicity of this active substance (see section 5.3). As nintedanib may cause foetal harm also in humans, it should not be used during pregnancy unless the clinical condition requires treatment. Pregnancy testing should be conducted at least prior to treatment with Vargatef.
Female patients should be advised to notify their doctor or pharmacist if they become pregnant during therapy with Vargatef.

If the patient becomes pregnant while receiving Vargatef, she should be apprised of the potential hazard to the foetus. Termination of the treatment with Vargatef should be considered.

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 new-borns/infants cannot be excluded. Breast-feeding should be discontinued during treatment with Vargatef.

Fertility
Based on preclinical investigations there is no evidence for impairment of male fertility (see section 5.3). There are no human or animal data on potential effects of nintedanib on female fertility available.