Pregnancy & Lactation : הריון/הנקה

4.6     Fertility, pregnancy and lactation

Women of childbearing potential/Contraception in males and females
Due to the unknown risk related to potential exposure during early pregnancy, women of childbearing potential must be advised not to become pregnant while using Torisel.

Men with partners of childbearing potential should use medically acceptable contraception while receiving Torisel (see section 5.3).

Pregnancy

There are no adequate data from the use of temsirolimus in pregnant women. Studies in animals have shown reproductive toxicity. In reproduction studies in animals, temsirolimus caused embryo/foetotoxicity that was manifested as mortality and reduced foetal weights (with associated delays in skeletal ossification) in rats and rabbits. Teratogenic effects (omphalocele) were seen in rabbits (see section 5.3).

The potential risk for humans is unknown. Torisel must not be used during pregnancy, unless the risk for the embryo is justified by the expected benefit for the mother. The ethanol content of this product should also be taken into account for pregnant women (see section 4.4).

Torisel contains propylene glycol (see section 4.4). Propylene glycol has not been shown to cause reproductive or developmental toxicity in animals or humans, however, it may reach the foetus.
Administration of ≥50 mg/kg/day propylene glycol to pregnant women should only be considered on a case by case basis.


Breast-feeding
It is unknown whether temsirolimus is excreted in human breast milk. The excretion of temsirolimus in milk has not been studied in animals. However, sirolimus, the main metabolite of temsirolimus, is excreted in milk of lactating rats. Because of the potential for adverse reactions in breast-fed infants from temsirolimus, breast-feeding should be discontinued during therapy. The ethanol content of this product should be taken into account in women who are breast-feeding (see section 4.4).

Torisel contains propylene glycol (see section 4.4). Propylene glycol has not been shown to cause reproductive or developmental toxicity in animals or humans, however, it has been found in milk and may be orally absorbed by a nursing infant. Administration of ≥50 mg/kg/day propylene glycol to lactating women should only be considered on a case by case basis.

Fertility

In male rats, decreased fertility and partly reversible reductions in sperm counts were reported (see section 5.3).