Changes to the prescribing information for alteplase (Activase) recently flew in under the radar.
A version of this article originally appeared on the Emergency Medicine PharmD blog.
Changes to the prescribing information for alteplase (Activase rt-PA) pertaining to contraindications to the drug's use in acute ischemic stroke (AIS) recently flew in under the radar.
The contraindications now read as follows:
Do not administer Activase to treat AIS in the following situations in which the risk of bleeding is greater than the potential benefit:
Without the old contraindications for comparison purposes, the changes may not be obvious. In a 2013 package insert, the contraindications read as follows (changes italicized):
Activase therapy in patients with AIS is contraindicated in the following situations because of an increased risk of bleeding, which could result in significant disability or death:
The changes, particularly the language introducing the contraindications, are significant. The consequences that used to be "significant disability or death" are now simply "situations in which the risk of bleeding is greater than the potential benefit."
If you didn't catch the specific changes, rt-PA is no longer contraindicated in patients with:
Furthermore, the language describing specific bleeding diatheses and what constitutes as "uncontrolled hypertension" is now very vague.
At this point, it is unclear if or when practice guidlines will be updated based on the new prescribing information.