May 23 2022

Classification of the active ingredient alteplase


Risk level in pregnancy: This medicine is classified as Category C.

Limited data on the use of this medicine during pregnancy is not indicative of fetal or maternal risk, because it probably does not cross the placenta because of their size. However, treatment with alteplase entails a risk of maternal hemorrhage when administered during labor.

There have been several observations about the use of this drug in women, whose babies were normal. In the case of a 29 year old patient treated with alteplase for pulmonary embolism, the baby died at 14 days of life from intracranial hemorrhage, which the authors of the communication attributed to prematurity and not the use of the drug.

According to experts opinion , it seems that there are no weighty objections against the use of medicine during pregnancy if the patient's disease requires it .

In addition, at doses somewhat lower than those used in human clinical, no fetal abnormalities were observed in experimental animals during organ formation, even when there has been a deadly effect on the embryo in rabbits at higher doses.

Update 18.07.2009

Meaning of category C

Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.