Pregnancy & Lactation : הריון/הנקה

4.6 Pregnancy and 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 fetus (see section 5.3) 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 section 5.3).
If pregnancy occurs during treatment the possibility of genetic counselling should be considered.


Page 7 of 17
Fertility

Men in fertile age must use effective contraception during treatment and 5 months after treatment (see section 4.4).
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 trabectedin.

Genetic counseling is also recommended for patients wishing to have children after therapy.

Lactation
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 section 4.3).