Orserdu Use In Pregnancy & Lactation

Women of childbearing potential/Contraception in males and females: ORSERDU should not be used during pregnancy or in women of childbearing potential not using contraception. Based on the mechanism of action of elacestrant and findings from reproductive toxicity studies in animals, ORSERDU can cause foetal harm when administered to pregnant women. Females of reproductive potential should be advised to use effective contraception during treatment with ORSERDU and one week after the last dose.
Pregnancy: There are no data from the use of elacestrant in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). ORSERDU should not be used during pregnancy or in women of childbearing potential not using contraception. The pregnancy status of females of reproductive potential should be verified prior to starting treatment with ORSERDU. If pregnancy occurs while taking ORSERDU, the patient must be informed of the potential hazard to the foetus and potential risk of miscarriage.
Breast-feeding: It is unknown whether elacestrant/metabolites are excreted in human milk. Because of the potential for serious adverse reactions in the breast-fed infant, it is recommended that lactating women should not breast-feed during treatment with ORSERDU and one week after the last dose of ORSERDU.
Fertility: Based on findings from animal studies (see Pharmacology: Toxicology: Preclinical safety data under Actions) and its mechanism of action, ORSERDU may impair fertility in females and males of reproductive potential.