Pregnancy: There are no data from the use of Jakavi in pregnant women.
Animal studies have shown that ruxolitinib is embryotoxic and foetotoxic. Teratogenicity was not observed in rats or rabbits. However, the exposure margins compared to the highest clinical dose were low and the results are therefore of limited relevance for humans (see Pharmacology: Toxicology: Preclinical safety data under Actions). The potential risk for humans is unknown. As a precautionary measure, the use of Jakavi during pregnancy is contraindicated (see Contraindications).
Women of childbearing potential/Contraception: Women of childbearing potential should use effective contraception during the treatment with Jakavi. In case pregnancy should occur during treatment with Jakavi, a risk/benefit evaluation must be carried out on an individual basis with careful counselling regarding potential risks to the foetus (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Breast-feeding: Jakavi must not be used during breast-feeding (see Contraindications) and breast-feeding should therefore be discontinued when treatment is started. It is unknown whether ruxolitinib and/or its metabolites are excreted in human milk. A risk to the breast-fed child cannot be excluded. Available pharmacodynamic/toxicological data in animals have shown excretion of ruxolitinib and its metabolites in milk (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Fertility: There are no human data on the effect of ruxolitinib on fertility. In animal studies, no effect on fertility was observed.