Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation
Contraception in men and women/women of childbearing potential
Based on findings in an animal study and its mechanism of action, pemigatinib can cause foetal harm when administered to a pregnant woman. Women of childbearing potential being treated with pemigatinib should be advised not to become pregnant and men being treated with pemigatinib should be advised not to father a child during treatment. An effective method of contraception should be used in women of childbearing potential and in men with women partners of childbearing potential during treatment with pemigatinib and for 1 week following completion of therapy. Since the effect of pemigatinib on the metabolism and efficacy of contraceptives has not been investigated, barrier methods should be applied as a second form of contraception, to avoid pregnancy.

Pregnancy
There are no available data from the use of pemigatinib in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Based on animal data and pharmacology of pemigatinib, Pemazyre should not be used during pregnancy unless the clinical condition of the women requires treatment with pemigatinib. A pregnancy test should be performed before treatment initiation to exclude pregnancy.

Breast-feeding
It is unknown whether pemigatinib or its metabolites are excreted in human milk. A risk to the breast- fed child cannot be excluded. Breast-feeding should be discontinued during treatment with Pemazyre and for 1 week following completion of therapy.

Fertility
There are no data on the impact of pemigatinib on human fertility. Animal fertility studies have not been conducted with pemigatinib (see section 5.3). Based on the pharmacology of pemigatinib, impairment of male and female fertility cannot be excluded.