Pregnancy Category C.
Dactinomycin has been shown to cause malformations and embryotoxicity in rats, rabbits and hamsters when given in doses of 50-100 μg/kg intravenously (3-7 times the maximum recommended human dose).
There are no adequate and well-controlled studies in pregnant women. Dactinomycin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether Dactinomycin is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Dactinomycin, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
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