Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

Women of childbearing potential

Women of childbearing potential are recommended to use contraception when treated with tirzepatide.
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 section 5.3). Tirzepatide is not recommended during pregnancy and in women of childbearing potential not using contraception. If a patient wishes to become pregnant, or pregnancy occurs, tirzepatide should be discontinued. Tirzepatide should be discontinued at least 1 month before a planned pregnancy due to the long half-life (see section 5.2).

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 section 5.3).