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What it Treats

Acute Ischemic Stroke

Activase (alteplase) is indicated for treating patients with acute ischemic stroke (sudden stroke), which is caused by a blood clot in the brain’s blood vessels. Patients can receive Activase only if they begin treatment within 3 hours after their stroke symptoms start and only after bleeding in the brain has been ruled out.

Acute Myocardial Infarction & Pulmonary Embolism

Activase (alteplase) is approved for treating an acute myocardial infarction, also known as a sudden heart attack. In patients whose heart attack puts them at low risk for death or heart failure, the benefit that comes from the use of Activase may be outweighed by the risk of stroke that Activase presents.

Activase (alteplase) is indicated to break apart an acute massive pulmonary embolism, which is a large blood clot lodged in the blood vessels of the lung. The pulmonary embolism must be severe enough to block blood flow to the lungs and cause an unsafe drop in blood pressure.

Important Safety Information

Important Safety Information – Acute Ischemic Stroke

Who should not take Activase?

Activase should not be used in patients who have: current bleeding in the brain; bleeding in the area between the brain and the thin tissues that cover the brain; active internal bleeding; recent (within 3 months) brain or spinal surgery or trauma; brain tumor, an abnormal connection between veins and arteries in the brain, or an abnormal bulge in the wall of an artery that supplies blood to the brain; problems with blood clotting; or current severe uncontrolled high blood pressure.

What are the possible serious side effects of Activase?

Bleeding: The most common side effect with Activase is bleeding. Some patients may or may not benefit from Activase because of an increased risk of bleeding, including those with the following conditions: recent major surgery; disease of blood vessels in the brain; recent bleeding in the brain; recent internal bleeding; recent trauma; uncontrolled high blood pressure; inflammation of the sac around the heart; infection of the inner lining of the heart and the heart valves; increased bleeding risk associated with liver or kidney problems; liver problems; pregnancy; bleeding in the eyes; swelling and infection associated with blood clots; elderly patients; patients on blood thinning drugs.

Allergic reaction (hypersensitivity): Allergic reactions including hives and severe or life-threatening allergic reactions can occur very quickly. Rare reports of death from severe allergic reactions have been reported. Swelling of the mouth and throat (angioedema) has been observed in patients treated for sudden stroke (acute ischemic stroke) and sudden heart attack (acute myocardial infarction). This occurred during and up to 2 hours after infusion of Activase. In many cases, patients were also taking angiotensin-converting enzyme inhibitors (a type of medication that can make blood vessels expand).

Migrated blood clot (thromboembolism): Drugs used to dissolve blood clots may be administered to patients with a high likelihood of a blood clot in the left chamber of the heart, such as patients with narrowing of a heart valve.

Cholesterol Embolization: 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.

What is the most common side effect with Activase?

The most common side effect with Activase is bleeding.

Patients and their caregivers are encouraged to report side effects to Genentech and the FDA. They may contact Genentech by calling 1-888- 835- 2555. They may contact the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

Please see accompanying full Prescribing Information for Activase for additional important safety information.


Important Safety Information – Acute Myocardial Infarction & Pulmonary Embolism

Who should not take Activase?

Activase should not be used in patients who have: active internal bleeding; history of recent stroke; recent (within 3 months) brain or spinal surgery or trauma; brain tumor, an abnormal connection between veins and arteries in the brain, or an abnormal bulge in the wall of an artery that supplies blood to the brain; problems with blood clotting; or current severe uncontrolled high blood pressure (hypertension).

What are the possible serious side effects of Activase?

Bleeding: The most common side effect with Activase is bleeding. Some patients may or may not benefit from Activase because of an increased risk of bleeding, including those with the following conditions: recent major surgery; disease of blood vessels in the brain; recent bleeding in the brain; recent internal bleeding; recent trauma; uncontrolled high blood pressure; inflammation of the sac around the heart; infection of the inner lining of the heart and the heart valves; tightening of blood vessels associated with liver or kidney problems; liver problems; pregnancy; bleeding in the eyes; blood clots; elderly patients; patients on blood thinning drugs.

Allergic reaction (hypersensitivity): Allergic reactions including hives and severe or life-threatening allergic reactions can occur very quickly. Rare reports of death from severe allergic reactions have been reported. Swelling of the mouth and throat (angioedema) has been observed in patients treated for sudden stroke (acute ischemic stroke) and sudden heart attack (acute myocardial infarction). This occurred during and up to 2 hours after infusion of Activase. In many cases, patients were also taking angiotensin-converting enzyme inhibitors (a type of medication that can make blood vessels expand).

Migrated blood clot (thromboembolism): Drugs used to dissolve blood clots may be administered to patients with a high likelihood of a blood clot in the left chamber of the heart, such as patients with narrowing of a heart valve or types of irregular heartbeat. Activase has not been shown to treat adequately underlying blood clots that form deep inside the body (mainly in the leg) in patients with PE. There is a risk of blood clots dislodging, traveling to the lung, and stopping blood flow to the lungs.

Cholesterol Embolization: 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.

What is the most common side effect with Activase?

The most common side effect with Activase is bleeding.

Patients and their caregivers are encouraged to report side effects to Genentech and the FDA. They may contact Genentech by calling 1-888- 835- 2555. They may contact the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

Please see accompanying full Prescribing Information for Activase for additional important safety information.