Pregnancy: There are no or a limited amount of data from the use of tirzepatide in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). Tirzepatide is not recommended during pregnancy and in women of childbearing potential not using contraception. If a patient wishes to become pregnant, tirzepatide should be discontinued at least 1 month before a planned pregnancy due to the long half-life of tirzepatide. Tirzepatide should not be used during pregnancy.
Breast-feeding: It is unknown whether tirzepatide is excreted in human milk. A risk to the newborn/infant cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from tirzepatide therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: The effect of tirzepatide on fertility in humans is unknown.
Animal studies with tirzepatide did not indicate direct harmful effects with respect to fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).