Tasigna Use In Pregnancy & Lactation

Pregnancy: There are no adequate data on the use of Tasigna in pregnant women. Studies in animals showed no teratogenicity, but embryo- and fetotoxicity was seen at doses which also showed maternal toxicity (see Pharmacology: Toxicology under Actions). Tasigna should not be used during pregnancy unless necessary. If it is used during pregnancy, the patient must be informed of the potential risk to the fetus.
Women of Child Bearing Potential: Women of childbearing potential must be advised to use highly effective method of contraception while receiving Tasigna and for up to 2 weeks after ending treatment.
Fertility: The effect of nilotinib on male and female fertility is not known. In animal studies no effects on sperm count/motility, and on fertility were noted in male and female rats up to the highest tested dose of approximately 5-fold greater than the recommended dosage for humans. (See Pharmacology: Toxicology under Actions).
Breast-feeding: It is not known whether nilotinib is excreted in human milk. Studies in animals demonstrate that nilotinib is excreted into breast milk. Women taking Tasigna should not breast-feed while taking Tasigna, as a risk to the infant cannot be excluded.