Giotrif Use In Pregnancy & Lactation

Pregnancy: Nonclinical 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 under Actions).
There are no studies in pregnant women using Afatinib dimaleate (Giotrif). The potential risk for humans is thus unknown. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with Afatinib dimaleate (Giotrif). Adequate contraceptive methods should be used during therapy and for at least 2 weeks after the last dose. If Afatinib dimaleate (Giotrif) is used during pregnancy or if the patient becomes pregnant while receiving Afatinib dimaleate (Giotrif), the patient should be apprised of the potential hazard to the foetus.
Lactation: Based on nonclinical data (see Pharmacology: Toxicology 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 Afatinib dimaleate (Giotrif).
Fertility: Fertility studies in humans have not been performed with Afatinib dimaleate (Giotrif). Available nonclinical toxicology data have shown effects on reproductive organs at higher doses (see Pharmacology: Toxicology under Actions). Therefore, an adverse effect of Afatinib dimaleate (Giotrif) therapy on human fertility cannot be excluded.