Tasigna Use In Pregnancy & Lactation

Pregnancy: Risk Summary: Tasigna can cause fetal harm when administered to a pregnant woman. There are no adequate data on the use of Tasigna in pregnant women. Reproductive studies in rats and rabbits have demonstrated that nilotinib induced embryo-toxicity and/or feto-toxicity (following prenatal exposure to nilotinib) at exposures equal to the one achieved in humans at the maximum recommended human dose of 400 mg twice daily. Tasigna should not be used during pregnancy unless necessary. If it is used during pregnancy or if the patient becomes pregnant while taking Tasigna, the patient must be informed of the potential risk to the fetus.
If a woman who is being treated with Tasigna is considering pregnancy, treatment discontinuation may be considered based on the eligibility criteria for discontinuing treatment. There is a limited amount of data on pregnancies in patients while attempting TFR. If pregnancy is planned during the TFR phase, the patient must be informed of a potential need to re-initiate Tasigna treatment during pregnancy (see Dosage & Administration and Precautions).
Animal Data: Nilotinib did not induce teratogenicity, but did show embryo- and feto-toxicity at doses which also showed maternal toxicity. Increased post implantation loss was observed in both the fertility study, with treatment of both males and females, and in the embryo-toxicity study with the treatment of females. Embryo-lethality and fetal effects (mainly decreased fetal weights, visceral and skeletal variations) in rats and increased resorption of fetuses and skeletal variations in rabbits were present in the embryo-toxicity studies. Exposure to nilotinib in females at No-Observed-Adverse-Effect-Levels (NOAEL) was generally less or equal to that in humans at 800 mg/day.
In a pre- and postnatal study, the oral administration of nilotinib to female rats from day 6 of gestation to day 21 or 22 postpartum resulted in maternal effects (reduced food consumption and lower body weight gains) and longer gestation period at 60 mg/kg. The maternal dose of 60 mg/kg was associated with decreased pup body weight and changes in some physical development parameters (the mean day for pinna unfolding, tooth eruption and eye opening was earlier). The NOAEL in maternal animals and offspring was a maternal dose of 20 mg/kg.
Lactation: Risk Summary: It is not known whether nilotinib is excreted in human milk. Studies in animals demonstrate that nilotinib is excreted into breast milk. Lactating women should not breast-feed while taking Tasigna and for 2 weeks after the last dose, as a risk to the infant cannot be excluded.
Females and males of reproductive potential: Contraception: Females: Females of reproductive potential must be advised to use effective method of contraception (methods that result in less than 1% pregnancy rates) while receiving Tasigna and for up to 2 weeks after ending treatment with Tasigna.
Infertility: 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.