Activase®
alteplase
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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.
Important Safety Information
Who should not be given 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 major head trauma; some 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 digestive or urinary tract 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; abnormal liver function; pregnancy; bleeding problems 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): The use of drugs to help dissolve blood clots can increase the risk of a clot breaking up and migrating in patients with high risk of clots in the left side of the heart, such as those with narrowed heart valves or some abnormal heart rhythms. Activase has not been shown to adequately treat deep vein blood clot in patients with pulmonary embolism. Blood clots that migrate can cause decreased blood flow to the area that they migrated to. A healthcare provider should evaluate this risk in these patients.
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.
What It Treats
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
Who should not be given 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 major head trauma; some 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 digestive and urinary 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; abnormal liver function; pregnancy; bleeding problems 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): The use of drugs to help dissolve blood clots can increase the risk of a clot breaking up and migrating in patients with high risk of clots in the left side of the heart, such as those with narrowed heart valves or some abnormal heart rhythms. Activase has not been shown to adequately treat deep vein blood clot in patients with pulmonary embolism. Blood clots that migrate can cause decreased blood flow to the area that they migrated to. A healthcare provider should evaluate this risk in these patients.
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.