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There are no adequate and well controlled or pharmacokinetic studies with Edurant in pregnant women. Studies in animals have shown no reproductive toxicity (see Pharmacology: Toxicology: Preclinical Safety Data: under Actions) and limited placenta passage. It is not known whether placental transfer of Edurant occurs in pregnant women. There was no teratogenicity with rilpivirine in rats and rabbits. Edurant should not be used during pregnancy unless clearly needed.
It is not known whether rilpivirine is excreted in human milk. Edurant is excreted in the milk of rats. Because of both the potential for HIV transmission and the potential for adverse reactions in breastfed infants, mothers should be instructed not to breastfeed if they are receiving Edurant.
