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Women of childbearing potential: Contraceptive measures should be used by women of childbearing potential during treatment with tafamidis, and for one month after stopping treatment, due to the prolonged half-life.
Pregnancy: There are no data on the use of tafamidis in pregnant women. Studies in animals have shown developmental toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). Tafamidis is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breast-feeding: Available data in animals have shown excretion of tafamidis in milk. A risk to the newborns/infants cannot be excluded. Tafamidis should not be used during breast-feeding.
Fertility: No impairment of fertility has been observed in nonclinical studies (see Pharmacology: Toxicology: Preclinical safety data under Actions).
