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Pregnancy Category C: Reteplase has been shown to have an abortifacient effect in rabbits when given in doses 3 times the human dose. Reproduction studies performed in rats at doses up to 15 times the human dose revealed no evidence of fetal anomalies; however, Reteplase administered to pregnant rabbits resulted in hemorrhage in the genital tract, leading to abortions in mid-gestation. There are no adequate and well controlled studies in pregnant women. Reteplase should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether Reteplase is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Reteplase is administered to a nursing woman.
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