Giotrif Use In Pregnancy & Lactation

Use in 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 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.
Use in 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 GIOTRIF.