Jyseleca Use In Pregnancy & Lactation

Women of childbearing potential/Contraception: Women of childbearing potential have to use effective contraception during and for at least 1 week after cessation of filgotinib treatment.
Pregnancy: There are no or limited amount of data from the use of filgotinib in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Based on findings in animals, filgotinib may cause foetal harm and is therefore contraindicated during pregnancy (see Contraindications).
Breast-feeding: It is unknown whether filgotinib is excreted in human milk. A risk to breastfed newborns/infants cannot be excluded. Therefore, Jyseleca should not be used during breast-feeding.
Fertility: In animal studies, decreased fertility, impaired spermatogenesis, and histopathological effects on male reproductive organs including lesions in testis which consisted of germ cell depletion/degeneration and/or tubular vacuolation with corresponding changes in epididymitis, such as reduced sperm content and/or increased cell debris were observed at exposures close to the clinical dose of 200 mg hence the risk of these adverse effects occurring at clinical doses for human use could not be ruled out (see Pharmacology: Toxicology: Preclinical safety data under Actions). The data from two dedicated clinical studies (MANTA and MANTA-RAy, n=240) to evaluate the testicular safety in men with inflammatory rheumatic diseases and inflammatory bowel diseases (IBD) showed a similar proportion of patients who had a 50% or more decrease from baseline in semen parameters at week 13 (pooled primary endpoint: 8 patients in the filgotinib group [6.7%], 10 patients in the placebo group [8.3%]). All 10 patients in the placebo group who experienced a ≥50% decrease from baseline in sperm concentration achieved reversibility by the Monitoring Phase (MP) week 52 whereas 2 out of 8 patients in the filgotinib group did not achieve reversibility. Of the 2 patients, 1 discontinued the study after the MP week 13 and the other patient did not demonstrate reversibility at the end of study despite completing the MP week 52. The data did not show any relevant changes in sex hormone levels or change from baseline in semen parameters across treatment groups. However, given that there are filgotinib-treated patients in whom reversibility of decreased sperm concentration has not been confirmed, it is recommended for clinicians to assess the appropriateness of use of the drug while taking into consideration individual patient's factors.
Animal studies did not indicate effects with respect to fertility in females.