Dacarbazine Pregnancy and Breastfeeding Warnings

Dacarbazine is also known as: DTIC-Dome

Dacarbazine Pregnancy Warnings

Dacarbazine has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of teratogenicity. Animal studies have also revealed a higher rate of resorption when male rats received the drug prior to mating. There are no controlled data in human pregnancy. Dacarbazine should only be given during pregnancy when benefit outweighs risk.

Dacarbazine has been shown to be teratogenic in rats when given in doses 20 times the human daily dose on day 12 of gestation. When administered at 10 times the human daily dose to male rats (twice weekly for 9 weeks), the drug did not effect the male libido. However, female rats mated to these male rats had a higher incidence of resorption than controls. In rabbits, administration of 7 times the human daily dose on days 6 through 15 of gestation, resulted in fetal skeletal anomalies.

Dacarbazine Breastfeeding Warnings

There are no data on the excretion of dacarbazine into human milk. Because many drugs are excreted into human milk and because of the potential for tumorigenicity shown in animal studies, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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