Omjjara Use In Pregnancy & Lactation

Women of childbearing potential/Contraception: Women of childbearing potential should be advised to avoid becoming pregnant whilst receiving Omjjara. It is currently unknown whether Omjjara may reduce the effectiveness of systemically acting hormonal contraceptives, therefore women using systemically acting hormonal contraceptives should add a barrier method during treatment and for at least 1 week after the last dose of Omjjara (see Precautions and Interactions).
Pregnancy: There are no data from the use of momelotinib in pregnant women. Studies in animals have shown embryo-foetal toxicity at exposures lower than human exposure at the recommended dose (see Pharmacology: Toxicology: Preclinical safety data under Actions). Based on its mechanism of action, Omjjara may cause foetal harm. As a JAK inhibitor, Omjjara has been shown to cause embryo-foetal mortality and teratogenicity in pregnant rats and rabbits at clinically-relevant exposures. Omjjara is contraindicated during pregnancy (see Contraindications). If Omjjara is used during pregnancy, or if the patient becomes pregnant while taking this medicinal product, the patient should discontinue treatment and be advised of the potential hazard to the foetus.
Breast-feeding: It is unknown whether momelotinib/metabolites are excreted in human milk. Momelotinib was present in rat pups following nursing from treated dams with adverse events in the offspring (see Pharmacology: Toxicology: Preclinical safety data under Actions). A risk to the breast-fed child cannot be excluded. Omjjara is contraindicated during breast-feeding (see Contraindications).
Fertility: There are no data on the effects of momelotinib on human male or female fertility. In animal studies, momelotinib impaired fertility in male and female rats (see Pharmacology: Toxicology: Preclinical safety data under Actions).