Yondelis Use In Pregnancy & Lactation

Pregnancy: No sufficient clinical data on exposed pregnancies are available. However, based on its known mechanism of action, trabectedin may cause serious birth defects when administered during pregnancy. Trabectedin crossed the placenta when administered to pregnant rats. Trabectedin should not be used during pregnancy. If pregnancy occurs during treatment, the patient must be informed of the potential risk to the foetus (see Pharmacology: Toxicology: Preclinical safety data under Actions) and be monitored carefully. If trabectedin is used at the end of pregnancy, potential adverse reactions should be monitored carefully in the newborns.
Women of childbearing potential: Women of childbearing potential must use effective contraception during treatment and 3 months thereafter, and immediately inform the treating physician if a pregnancy occurs (see Pharmacology: Toxicology: Preclinical safety data under Actions).
If pregnancy occurs during treatment, the possibility of genetic counselling should be considered.
Breast-feeding: It is not known whether trabectedin is excreted in human milk. The excretion of trabectedin in milk has not been studied in animals. Breast-feeding is contraindicated during treatment and 3 months thereafter (see Contraindications).
Fertility: Men in fertile age must use effective contraception during treatment and 5 months after treatment (see Precautions).
Trabectedin can have genotoxic effects. Advice on conservation of ovules or sperm should be sought prior to treatment because of the possibility of irreversible infertility due to therapy with Yondelis.
Genetic counselling is also recommended for patients wishing to have children after therapy.