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Pregnancy: There is a limited amount of data from the use of METALYSE in pregnant women. Nonclinical studies performed with tenecteplase have shown bleeding with secondary mortality of dams due to the known pharmacological activity of the drug and in a few cases abortion and resorption of the foetus occurred (effects only have been observed with repeated dose administration). Tenecteplase is not considered to be teratogenic (see Pharmacology: Toxicology under Actions).
The benefit of treatment must be evaluated against the potential risks in case of myocardial infarction during pregnancy.
Lactation: It is not known if tenecteplase is excreted into human milk.
Caution should be exercised when METALYSE is administered to a nursing woman and a decision must be made whether breastfeeding should be discontinued for the first 24 hours after administration of METALYSE.
Fertility: Clinical data as well as nonclinical studies on fertility are not available for tenecteplase (METALYSE).
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