Information for Healthcare Providers / Patients

Activase® (alteplase)

Side Effect Reporting

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.

You may also report side effects to Genentech at (888) 835-2555.

What it Treats

Activase® (alteplase) is indicated for treating patients with acute ischemic 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.

Activase is approved for treating an acute myocardial infarction, also known as a 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 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 for AIS

Activase can cause bleeding and 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.

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; high likelihood of developing a blood clot in the left chamber of the heart; 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.

Swelling of the mouth and throat (orolingual angioedema) has been observed in patients treated for acute ischemic stroke and 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. Patients treated with Activase should be monitored during and for several hours after infusion for signs of orolingual angioedema. If orolingual angioedema develops, stop the infusion and immediately give appropriate therapy.

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.

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 visit www.activase.com for the Activase full prescribing information for additional important safety information.

Important Safety Information for AMI and PE

Activase can cause bleeding and 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.

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; blood clot in the left chamber of the heart; 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.

Swelling of the mouth and throat (orolingual angioedema) has been observed in patients treated for acute ischemic stroke and 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. Patients treated with Activase should be monitored during and for several hours after infusion for signs of orolingual angioedema. If orolingual angioedema develops, stop the infusion and immediately give appropriate therapy.

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.

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.

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 visit www.activase.com for the Activase full prescribing information for additional important safety information.

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