Lumirix Use In Pregnancy & Lactation

Contraception in women of childbearing potential: Women of childbearing potential have to use effective contraception during treatment and for 4 weeks after discontinuation of treatment.
Pregnancy: There are no or limited amount of data from the use of ruxolitinib in pregnant women. Data on systemic absorption of topical ruxolitinib during pregnancy are lacking. There could also be individual factors (e.g. damaged skin barrier, excessive use) that contribute to an increased systemic exposure.
Animal studies have shown that ruxolitinib is embryotoxic and foetotoxic following oral administration. Teratogenicity was not observed in rats or rabbits (see Pharmacology: Toxicology: Preclinical safety data under Actions). Lumirix is contraindicated during pregnancy (see Contraindications).
Breast-feeding: No data are available regarding the presence of ruxolitinib in human milk, the effects on the breastfed child, or the effects on milk production after topical application of Lumirix. Following oral administration of ruxolitinib to lactating rats, ruxolitinib and/or its metabolites were present in the milk with a concentration 13-fold higher than the maternal plasma concentration. In juvenile rat studies, oral administration of ruxolitinib resulted in effects on growth and bone measures (see Pharmacology: Toxicology: Preclinical safety data under Actions). Lumirix is contraindicated during breast-feeding (see Contraindications) and treatment must be discontinued approximately 4 weeks before the beginning of breastfeeding.
Fertility: There are no human data on the effect of ruxolitinib on fertility. In animal studies, no effect of oral ruxolitinib on fertility was observed.