Vyndamax Use In Pregnancy & Lactation

Women of childbearing potential: Contraceptive measures should be used by women of childbearing potential during treatment with VYNDAMAX, and, due to the prolonged half-life, for one month after stopping treatment.
VYNDAMAX is not recommended in women of childbearing potential not using contraception.
Pregnancy: There are no adequate data on the use of VYNDAMAX in pregnant women. Studies in animals have shown developmental toxicity (see Pharmacology: Toxicology: Nonclinical safety data under Actions). The potential risk for humans is unknown. VYNDAMAX is not recommended during pregnancy.
To monitor outcomes of pregnant women exposed to VYNDAMAX, a Tafamidis Enhanced Surveillance for Pregnancy Outcomes (TESPO) program has been established. If a pregnancy occurs in a woman being treated with VYNDAMAX, medical or healthcare professionals are encouraged to report the pregnancy by contacting the Marketing Authorisation Holder's local office.
Breastfeeding: Nonclinical data demonstrate that tafamidis is secreted in the milk of lactating rats. While the effect of VYNDAMAX on nursing infants after administration to the mother has not been studied, a risk to infants cannot be excluded. Breastfeeding is not recommended during treatment with VYNDAMAX.
Fertility: There were no effects of tafamidis on fertility, reproductive performance or mating behaviour in the rat at any dose (see Pharmacology: Toxicology: Nonclinical safety data under Actions).