Information for Patients / Medical Professionals / Our Medicines

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.

Indication

Acute Ischemic Stroke:

Activase® (Alteplase) 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.

Important Safety Information

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 imagining method sensitive for the presence of hemorrhage (see CONTRAINDICATIONS)

Activase therapy in patients with AIS is contraindicated in certain situations (e.g. suspicion of subarachnoid hemorrhage on pretreatment evaluation, recent (within 3 months) intracranial or intraspinal surgery, history of intracranial hemorrhage, uncontrolled hypertension at time of treatment, active internal bleeding, known bleeding diathesis (e.g. current use of oral anticoagulants, administration of heparin within 48 hours of onset of stroke, platelet count <100,000) (see CONTRAINDICATIONS for full list)

The most common complication during Activase therapy is bleeding. Should serious bleeding in a critical location (intracranial, gastrointestinal, retroperitoneal, pericardial) occur, Activase therapy should be discontinued immediately. Death and permanent disability are not uncommonly reported in patients who have experienced stroke (including intracranial bleeding) and other serious bleeding episodes.

The risks of Activase therapy may be increased and should be weighed against the anticipated benefits in certain conditions. [See WARNINGS in full prescribing information].

  •  Patients with severe neurological deficit (e.g., NIHSS >22) at presentation.

There is an increased risk of intracranial hemorrhage in these patients.

  •  Patients with major early infarct signs on a computerized cranial tomography (CT) scan (e.g., substantial edema, mass effect, or midline shift).

Treatment of patients with minor neurological deficit or with rapidly improving symptoms is not recommended.

Orolingual angioedema has been observed in post-marketing experience in patients treated with Activase for AIS. Patients should be monitored during and for several hours after infusion for signs of orolingual angioedema.

Please see full Prescribing Information at www.activase.com for additional important safety information.

ACTIVASE (AMI)

Indication: Acute Myocardial Infarction

Activase®(Alteplase) is indicated for use in the management of acute myocardial infarction in adults for the improvement of ventricular function following AMI, the reduction of the incidence of congestive heart failure, and the reduction of mortality associated with AMI. Treatment should be initiated as soon as possible after the onset of AMI symptoms (see CLINICAL PHARMACOLOGY).

Important Safety Information

Activase therapy in patients with Acute Myocardial Infarction (AMI) is contraindicated in certain situations because of an increased risk of bleeding (e.g. active internal bleeding, history of cerebrovascular accident, recent intracranial or intraspinal surgery or trauma, severe uncontrolled hypertension) [See Contraindications in the full prescribing information].

The most common complication during Activase therapy is bleeding. Should serious bleeding in a critical location (intracranial, gastrointestinal, retroperitoneal, pericardial) occur, Activase therapy should be discontinued immediately, along with any concomitant therapy with heparin.

The risks of Activase therapy for all approved indications may be increased and should be weighed against the anticipated benefits in certain conditions [See WARNINGS in full prescribing information].

Cholesterol embolism has been reported rarely in patients treated with all types of thrombolytic agents; the true incidence is unknown.

Coronary thrombolysis may result in arrhythmias associated with reperfusion. It is recommended that antiarrhythmic therapy for bradycardia and/or ventricular irritability be available when infusions of Activase are administered.

Orolingual angioedema has been observed in post-market experience in patients treated for acute myocardial infarction. Patients should be monitored during and for several hours after infusion for signs of orolingual angioedema.

Please see full Prescribing Information at www.activase.com for additional important safety information.

ACTIVASE (PE)

Indication: Pulmonary Embolism

Activase®(Alteplase) is indicated in the management of acute massive pulmonary embolism (PE) in adults:

— For the lysis of acute pulmonary emboli, defined as obstruction of blood flow to a lobe or multiple segments of the lungs.

— For the lysis of pulmonary emboli accompanied by unstable hemodynamics, e.g., failure to maintain blood pressure without supportive measures. The diagnosis should be confirmed by objective means, such as pulmonary angiography or noninvasive procedures such as lung scanning.

Important Safety Information

Activase therapy in patients with Pulmonary Embolism (PE) is contraindicated in certain situations because of an increased risk of bleeding (e.g. active internal bleeding, history of cerebrovascular accident, recent intracranial or intraspinal surgery or trauma, severe uncontrolled hypertension) [See Contraindications in the full prescribing information].

The most common complication during Activase therapy is bleeding.Should serious bleeding in a critical location (intracranial, gastrointestinal, retroperitoneal, pericardial) occur, Activase therapy should be discontinued immediately, along with any concomitant therapy with heparin.

The risks of Activase therapy for all approved indications may be increased and should be weighed against the anticipated benefits in certain conditions [See WARNINGS in full prescribing information].

Treatment of PE with Activase has not been shown to constitute adequate clinical treatment of underlying deep vein thrombosis. The possible risk of reembolization due to the lysis of underlying deep venous thrombi should be considered.

Please see full Prescribing Information at www.activase.com for additional important safety information.