Giotrif Use In Pregnancy & Lactation

Pregnancy: Non-clinical studies with afatinib have shown no signs of teratogenicity up to and including maternally lethal dose levels. Adverse changes were restricted to overtly toxic dose levels (see Pharmacology: Toxicology: Preclinical safety data under Actions). There are no studies in pregnant women using GIOTRIF. The potential risk for humans is thus unknown. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with GIOTRIF. Adequate contraceptive methods should be used during therapy and for at least 2 weeks after the last dose. If GIOTRIF is used during pregnancy or if the patient becomes pregnant while receiving GIOTRIF, the patient should be apprised of the potential hazard to the foetus.
Breast-feeding: Based on non-clinical data (see Pharmacology: Toxicology: Preclinical safety data under Actions), it is likely that afatinib is excreted in human milk. A risk to the nursing child cannot be excluded. Mothers should be advised against breast-feeding while receiving GIOTRIF.
Fertility: Fertility studies in humans have not been performed with GIOTRIF. Available non-clinical toxicology data have shown effects on reproductive organs at higher doses (see Pharmacology: Toxicology: Preclinical safety data under Actions). Therefore, an adverse effect of GIOTRIF therapy on human fertility cannot be excluded.