It is not known whether denileukin can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Animal reproduction studies have not been conducted with denileukin. Denileukin should be given to a pregnant woman only if clearly needed.
It is not known whether denileukin 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 denileukin, a decision should be made whether to discontinue nursing or to discontinue denileukin, taking into account the importance of the drug to the mother.
There have been no studies to assess the carcinogenic potential of denileukin. Denileukin showed no evidence of mutagenicity in the Ames test and the chromosomal aberration assay. There have been no studies to assess the effect of denileukin on fertility.
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