Adverse Reactions and Warnings

The most serious adverse event reported subsequent to Activase administration is bleeding. If serious intracranial, gastrointestinal, retroperitoneal, or pericardial bleeding occurs, treatment must be immediately discontinued. Allergic reactions, including anaphylactoid reactions, laryngeal edema, and urticaria have also been reported. The product should be used with extreme caution in pregnant women, for whom there are no well-controlled studies. Activase has an embryocidal effect in rabbits when administered in doses of twice the level used to treat AMI in humans. Caution should also be exercised with nursing mothers as it is not known if Activase is excreted into human milk. Negative results were recorded when the product was subjected to a mutagenicity test (the Ames test), chromosomal aberration assays in human lymphocytes, and short-term tumorigenicity studies. Long-term studies in animals to evaluate carcinogenic potential or effect on fertility have not been undertaken.

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