Koselugo Use In Pregnancy & Lactation

Women of childbearing potential/Contraception in males and females: Women of childbearing potential should be advised to avoid becoming pregnant while receiving Koselugo. It is recommended that a pregnancy test should be performed on women of childbearing potential prior to initiating treatment.
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. It cannot be excluded that selumetinib may reduce the effectiveness of oral contraceptives, therefore women using hormonal contraceptives should be recommended to add a barrier method (see Interactions).
Pregnancy: There are no data on the use of selumetinib 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 and in women of childbearing potential not using contraception (see Precautions).
If a female patient or a female partner of a male patient receiving Koselugo becomes pregnant, the female patient should be apprised of the potential risk to the foetus.
Breastfeeding: It is not known whether selumetinib, or its metabolites, are excreted in human milk. Selumetinib and its active metabolite are excreted in the milk of lactating mice (see Pharmacology: Toxicology: Preclinical safety data under Actions). A risk to the breastfed child cannot be excluded, therefore breastfeeding should be discontinued during treatment with Koselugo.
Fertility: There are no data on the effect of Koselugo on human fertility. Selumetinib 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).