Information for Healthcare Providers / Patients

Activase® (alteplase)

• Full Prescribing Information

What it Treats

Activase® (Alteplase) is approved for treating heart attacks and acute massive pulmonary embolism. Activase is also called tissue plasminogen activator, or t-PA, and can be used to treat patients with acute ischemic stroke. For certain patients, Activase may improve the chances of recovery from stroke with little or no disability. Patients can receive Activase only if they begin treatment within 3 hours after their stroke symptoms start and only after they have had a scan to rule out bleeding in the brain.

Important Safety Information

• All thrombolytic agents increase the risk of bleeding, including bleeding in the brain, and should be used only in eligible patients. In addition, drug therapy that dissolves blood clots increases the risk of stroke, including stroke caused by bleeding into the brain, particularly in elderly patients.
• Not all patients will be eligible for Activase therapy, including those patients in the following situations, because of an increased risk of bleeding which could result in significant disability or death: active internal bleeding; history of stroke; recent brain or spinal surgery or trauma; brain tumor, an abnormal connection between veins and arteries, or an abnormal bulge in the wall of an artery; problems with blood clotting; or severe uncontrolled high blood pressure.
• A plug of cholesterol that blocks an artery (cholesterol embolism) has been reported rarely in patients treated with all types of clot dissolving agents. This is a serious condition which can be lethal, and is also associated with invasive medical procedures involving the arteries and veins.
• Swelling of the mouth and throat (orolingual angioedema) has been observed in patients treated for acute myocardial infarction. This occurred during and up to 2 hours after infusion of Activase. Patients treated with Activase should be monitored during and for several hours after infusion for signs of orolingual angioedema.

Important Safety Information (stroke)

• There are risks involved with Activase treatment. Because Activase is a medication that causes clots of be dissolved, the most common side effect is bleeding, including bleeding in the brain; this is called intracranial hemorrhage (ICH).
• Not all patients will be eligible for Activase therapy, including those patients in the following situations because of an increased risk of bleeding which could result in significant disability or death: evidence of ICH at time of hospital evaluation or a history of ICH, possibility of bleeding in the lower part of the brain at time of hospital evaluation, recent (within 3 months) surgery or trauma, a serious head injury or previous stroke; having a seizure when the stroke began, severe uncontrolled high blood pressure; active internal bleeding, brain tumor, an abnormal connection between veins and arteries, or an abnormal bulge in the wall of an artery, or problems with blood clotting due to a low platelet count or current use of blood thinning drugs.
• Swelling of the mouth and throat (orolingual angioedema) has been observed in patients treated for acute ischemic stroke. This occurred during and up to 2 hours after infusion of Activase. Patients treated with Activase should be monitored during and for several hours after infusion for signs of orolingual angioedema. View full prescribing information for additional safety information.