Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

Pregnancy
There are no data from the use of belzutifan in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Belzutifan is not recommended during pregnancy and in women of childbearing potential not using contraception.

Breast-feeding
It is unknown whether belzutifan or its metabolites are excreted in human milk. A risk to newborns/infants cannot be excluded. Breast-feeding should be discontinued during treatment with belzutifan and for 1 week after the last dose.

Women of child-bearing potential/ contraception in males and females
Pregnancy Testing
The pregnancy status of females of reproductive potential should be verified prior to initiating treatment with belzutifan.

Contraception
Belzutifan may cause embryo-foetal harm, including foetal loss, when administered to a pregnant woman (see sections 4.4 and 5.3).

Females
Females of reproductive potential should be advised to use highly effective contraception during treatment with belzutifan and for at least 1 week after the last dose. Use of belzutifan may reduce the efficacy of hormonal contraceptives. Patients using hormonal contraceptives should be advised to use an alternative non-hormonal contraceptive method or have their male partner use a condom during treatment with belzutifan (see section 4.4).

Males
Male patients and their female partner of reproductive potential should be advised to use highly effective contraception during male patient treatment with belzutifan and for at least 1 week after the last dose (see section 4.4). Advise male patients with female partners who are pregnant to use barrier method of contraception during treatment with belzutifan and 1 week after the last dose.

Fertility
Based on findings in animals, belzutifan may impair fertility in males and females of reproductive potential (see section 5.3). Advise patients of this potential risk. The reversibility of the effect on fertility is unknown. Family planning should be discussed with patients as appropriate.