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Pregnancy: There is a limited amount of data from the use of ACTILYSE in pregnant women.
Non-clinical studies performed with alteplase in doses higher than human doses exhibited fetal immaturity and/or embryotoxicity, secondary to the known pharmacological activity of the drug. Alteplase is not considered to be teratogenic.
In cases of an acute life-threatening disease the benefit has to be evaluated against the potential risk.
Lactation: It is not known if alteplase is excreted into human milk.
Caution should be exercised when ACTILYSE is administered to a nursing woman and a decision must be made whether breast-feeding should be discontinued for the first 24 hours after administration of ACTILYSE.
Fertility: Clinical data on fertility are not available for ACTILYSE. Non-clinical studies performed with alteplase showed no adverse effect on fertility.
