Alteplase has been assigned to pregnancy category C by the FDA. Alteplase has been shown to be embryocidal in rabbits at intravenous doses two times the human dose for AMI. There are no controlled data in human pregnancy. Alteplase is only recommended for use during pregnancy when benefit outweighs risk.

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There are no data on the excretion of alteplase into human milk. The manufacturer recommends that caution be used when administering alteplase to nursing women.

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