Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and lactation

Women of childbearing potential

Effective contraception must be used during Rapamune therapy and for 12 weeks after Rapamune has been stopped (see section 4.5).

Pregnancy

There are no or limited amount of data from the use of sirolimus in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Rapamune should not be used during pregnancy unless clearly necessary.
Effective contraception must be used during Rapamune therapy and for 12 weeks after Rapamune has been stopped.

       Breast-feeding

Following administration of radiolabelled sirolimus, radioactivity is excreted in the milk of lactating rats. It is unknown whether sirolimus is excreted in human milk. Because of the potential for adverse reactions in breast-fed infants from sirolimus, breast-feeding should be discontinued during treatment with Rapamune.

Fertility

Impairments of sperm parameters have been observed among some patients treated with Rapamune. These effects have been reversible upon discontinuation of Rapamune in most cases (see section 5.3).