Important Safety Information for Activase (t-PA)

Acute Ischemic Stroke

Activase therapy in patients with pulmonary embolism is contraindicated in the following situations because of an increased risk of bleeding, which could result in significant disability or death:

  • Evidence of intracranial hemorrhage on pretreatment evaluation
  • Suspicion of subarachnoid hemorrhage on pretreatment evaluation
  • Recent (within 3 months) intracranial or intraspinal surgery, serious head trauma, or previous stroke
  • History of intracranial hemorrhage
  • Uncontrolled hypertension at time of treatment (e.g., > 185 mm Hg systolic or > 110 mm Hg diastolic)
  • Seizure at the onset of stroke
  • Active internal bleeding
  • Intracranial neoplasm, arteriovenous malformation, or aneurysm
  • Known bleeding diathesis including but not limited to:
    • – Current use of oral anticoagulants (e.g., warfarin sodium) or an International Normalized Ratio (INR) > 1.7 or a prothrombin time (PT) > 15 seconds
    • – Administration of heparin within 48 hours preceding the onset of stroke and have an elevated activated partial thromboplastin time (aPTT) at presentation
    • – Platelet count < 100,000/mm3


View the full prescribing information.

Indication: Activase is indicated for the management of acute ischemic stroke in adults for improving neurological recovery and reducing the incidence of disability. Treatment should only be initiated within 3 hours after the onset of stroke symptoms, and after exclusion of intracranial hemorrhage by a cranial computerized tomography (CT) scan or other diagnostic imaging method sensitive for the presence of hemorrhage (see CONTRAINDICATIONS in the full prescribing information).

Safety Information: All thrombolytic agents increase the risk of bleeding, including intracranial bleeding, and should be used only in appropriate patients. Not all patients with acute ischemic stroke will be eligible for Activase therapy, including patients with evidence of recent or active bleeding; recent (within 3 months) intracranial or intraspinal surgery, serious head trauma, or previous stroke; uncontrolled high blood pressure; or impaired blood clotting.


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