Tykerb Use In Pregnancy & Lactation

Women of childbearing potential: Women of childbearing potential should be advised to use adequate contraception and avoid becoming pregnant while receiving treatment with Tykerb and for at least 5 days after the last dose.
Pregnancy: There are no adequate data from the use of Tykerb in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). The potential risk for humans is not known.
Tykerb should not be used during pregnancy unless clearly necessary.
Breast-feeding: The safe use of Tykerb during breast-feeding has not been established. It is not known whether lapatinib is excreted in human milk. In rats, growth retardation was observed in pups which were exposed to lapatinib via breast milk. Breast-feeding must be discontinued in women who are receiving therapy with Tykerb and for at least 5 days after the last dose.
Fertility: There are no adequate data from the use of Tykerb in women of childbearing potential.