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Nilotinib Pregnancy and Breastfeeding Warnings

Nilotinib is also known as: Tasigna

Nilotinib Pregnancy Warnings

Nilotinib has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of maternal toxicity (as shown by decreased gestation weight, gravid uterine weight, net weight gain, mortality, abortion, and decreased food consumption), and embryo-fetal toxicity (as shown by increased resorption, post-implantation loss, a decrease in viable fetuses, and minor skeletal anomalies). Nilotinib is not considered teratogenic. There are no controlled data in human pregnancy. Nilotinib should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

Women taking nilotinib should be advised to avoid becoming pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

See references

Nilotinib Breastfeeding Warnings

There are no data on the excretion of nilotinib into human milk. Because many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing infants from nilotinib, a decision should be made whether to discontinue nursing or to discontinue nilotinib taking into account the importance of the drug to the mother.

See references

References for pregnancy information

  1. "Product Information. Tasigna (nilotinib)." Novartis Pharmaceuticals, East Hanover, NJ.

References for breastfeeding information

  1. "Product Information. Tasigna (nilotinib)." Novartis Pharmaceuticals, East Hanover, NJ.

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