Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

Pregnancy
There are no data on the use of belumosudil in pregnant women.

Belumosudil can cause foetal harm based on findings from animal studies (see section 5.3) and its mechanism of action. In pregnant rats and rabbits, oral administration of belumosudil resulted in maternal and/or foetal toxicity at doses below the recommended human dose. As a precautionary measure, belumosudil is contraindicated in pregnancy (see section 4.3).

Women of childbearing potential/Contraception in males and females

Women of childbearing potential should be informed that animal studies show belumosudil to be harmful to the developing foetus. Women of childbearing potential must have their pregnancy status verified prior to initiating treatment with belumosudil, and must use a reliable and highly effective method of contraception during treatment with belumosudil and for at least one week after the last dose of belumosudil. In case pregnancy should occur during treatment with belumosudil, a risk/benefit evaluation must be carried out on an individual basis with careful counselling regarding potential risks to the foetus (see sections 4.4 and 5.3).

Male patients with female partners of childbearing potential should be advised that their female partners should avoid becoming pregnant while taking belumosudil and of the potential risks to a foetus.

Male patients with female partners of childbearing potential must use a highly effective method of contraception during treatment and for at least one week after the last dose of belumosudil (see section 4.4).

Breast-feeding

It is unknown whether belumosudil or its metabolites are excreted in human milk. No data are available regarding the presence of belumosudil or its metabolites in animal or human milk or its effects on the breast-fed child, or on milk production. A risk to the infant cannot be excluded. Because of the potential for serious adverse reactions in a breast-fed child, breast-feeding should be 
discontinued during treatment with belumosudil and for at least one week after the last dose (see section 4.4).

Fertility

There are no human data on the effect of belumosudil on fertility. Based on findings from animal studies, belumosudil may impair male and female fertility at dose levels above the recommended clinical dose. The effects on fertility are reversible (see section 5.3).