Pregnancy: Dacarbazine has been shown to be mutagenic, teratogenic and carcinogenic in animals. It must be assumed that an increased risk for teratogenic effects exists in humans. Therefore, DAKACIN is contraindicated during pregnancy (see Contraindications).
Women of child-bearing potential have to use effective contraception during treatment and for 6 months following completion of treatment.
Breast-feeding: DAKACIN is contraindicated during breast-feeding (see Contraindications).
Fertility: Due to the genotoxic potential of dacarbazine, patients are advised to seek advice on fertility preservation options before starting treatment with dacarbazine. After treatment with dacarbazine, patients planning pregnancy are advised to seek genetic counselling.
Women of childbearing potential/contraception in men and women: Due to the genotoxic potential of dacarbazine (see Pharmacology: Toxicology: Preclinical safety data under Actions), women of childbearing potential should use effective contraceptive measures while being treated with Dacarbazine and for 6 months following completion of treatment.
Men are recommended to use effective contraceptive measures and to not father a child while receiving Dacarbazine and for 3 months following completion of treatment.
Patients considering pregnancy should seek genetic counselling after the period of contraceptive use.
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