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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. Please report to Pfizer all cases of patients becoming pregnancy while receiving tafamidis.
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).
