Koselugo Use In Pregnancy & Lactation

Contraception in males and females: Women of childbearing potential should be advised to avoid becoming pregnant while receiving KOSELUGO. Both male and female patients (of reproductive potential) should be advised to use effective contraception during and for at least 1 week after completion of treatment with KOSELUGO.
KOSELUGO is not recommended in women of childbearing potential not using contraception.
Pregnancy: There are no data on the use of KOSELUGO in pregnant women. Studies in animals have shown reproductive toxicity including embryofoetal death, structural defects and reduced foetal weights (see Pharmacology: Toxicology: Preclinical safety data under Actions). KOSELUGO is not recommended during pregnancy.
It is recommended that a pregnancy test should be performed on women of childbearing potential prior to initiating treatment.
Advise women of childbearing potential to avoid becoming pregnant while receiving KOSELUGO. If a female patient or a female partner of a male patient receiving KOSELUGO becomes pregnant, she should be apprised of the potential hazard to the foetus.
Lactation/Breast Feeding: KOSELUGO and its active metabolite are excreted in the milk of lactating mice (see Pharmacology: Toxicology: Preclinical safety data under Actions). It is not known whether KOSELUGO, or its metabolites, are excreted in human milk. A risk to the breast-fed infant cannot be excluded, therefore breast-feeding mothers are advised not to breast-feed during treatment with KOSELUGO.
Fertility: There are no data on the effect of KOSELUGO on human fertility.
KOSELUGO had no impact on fertility and mating performance in male and female mice, although a reduction in embryonic survival was observed in female mice (see Pharmacology: Toxicology: Preclinical safety data under Actions).