Tasigna Use In Pregnancy & Lactation

Women of childbearing potential/Contraception: Women of childbearing potential have to use highly effective contraception during treatment with nilotinib and for up to two weeks after ending treatment.
Pregnancy: There are no or limited amount of data from the use of nilotinib in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). Tasigna should not be used during pregnancy unless the clinical condition of the woman requires treatment with nilotinib. If it is used during pregnancy, the patient must be informed of the potential risk to the foetus.
If a woman who is being treated with nilotinib is considering pregnancy, treatment discontinuation may be considered based on the eligibility criteria for discontinuing treatment as described in Dosage & Administration and Precautions. There is a limited amount of data on pregnancies in patients while attempting treatment-free remission (TFR). If pregnancy is planned during the TFR phase, the patient must be informed of a potential need to re-initiate nilotinib treatment during pregnancy (see Dosage & Administration and Precautions).
Breast-feeding: It is unknown whether nilotinib is excreted in human milk. Available toxicological data in animals have shown excretion of nilotinib in milk (see Pharmacology: Toxicology: Preclinical safety data under Actions). A risk to the newborns/infants cannot be excluded. Tasigna should not be used during breast-feeding.
Fertility: Animal studies did not show an effect on fertility in male and female rats (see Pharmacology: Toxicology: Preclinical safety data under Actions).