Information for Patients / Medical Professionals

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 treatment of acute ischemic stroke. Exclude intracranial hemorrhage as the primary cause of stroke signs and symptoms prior to initiation of treatment. Initiate treatment as soon as possible but within 3 hours after symptom onset.

Important Safety Information

Contraindications

Do not administer Activase to treat acute ischemic stroke in the following situations in which the risk of bleeding is greater than the potential benefit: current intracranial hemorrhage (ICH); subarachnoid hemorrhage; active internal bleeding; recent (within 3 months) intracranial or intraspinal surgery or serious head trauma; presence of intracranial conditions that may increase the risk of bleeding; bleeding diathesis; and current severe uncontrolled hypertension.

Warnings and Precautions

Bleeding

Activase can cause internal or external bleeding. Avoid intramuscular injections and trauma to the patient. Fatal cases of hemorrhage associated with traumatic intubation in patients administered Activase have been reported. Heparin, aspirin, or Activase may cause bleeding complications; therefore carefully monitor for bleeding. If serious bleeding occurs, terminate the Activase infusion.

Orolingual Angioedema

Monitor patients during and for several hours after infusion for orolingual angioedema. If angioedema develops, discontinue the Activase infusion and promptly institute appropriate therapy.

Cholesterol Embolization

Cholesterol embolism, sometimes fatal, has been reported rarely in patients treated with thrombolytic agents.

Coagulation Tests May be Unreliable during Activase Therapy

Coagulation tests and/or measures of fibrinolytic activity may be unreliable during Activase therapy.

Adverse Reactions

The most frequent adverse reaction associated with Activase AIS therapy is bleeding.

Allergic type reactions, e.g., anaphylactoid reaction, laryngeal edema, orolingual angioedema, rash, and urticaria have been reported.

ACTIVASE (AMI)

Indication: Acute Myocardial Infarction

Activase® is indicated for use in acute myocardial infarction (AMI) for the reduction of mortality and reduction of the incidence of heart failure.

Limitation of Use: The risk of stroke may outweigh the benefit produced by thrombolytic therapy in patients whose AMI puts them at low risk for death or heart failure.

Important Safety Information

Contraindications

Do not administer Activase to treat AMI in the following situations in which the risk of bleeding is greater than the potential benefit: active internal bleeding; history of recent stroke; recent (within 3 months) intracranial or intraspinal surgery or serious head trauma; presence of intracranial conditions that may increase the risk of bleeding; bleeding diathesis; and current severe uncontrolled hypertension.

Warnings and Precautions

Bleeding

Activase can cause internal or external bleeding. Avoid intramuscular injections and trauma to the patient. Fatal cases of hemorrhage associated with traumatic intubation in patients administered Activase have been reported. Heparin, aspirin, or Activase may cause bleeding complications; therefore carefully monitor for bleeding. If serious bleeding occurs, terminate the Activase infusion.

Orolingual Angioedema

Monitor patients during and for several hours after infusion for orolingual angioedema. If angioedema develops, discontinue the Activase infusion and promptly institute appropriate therapy.

Cholesterol Embolization

Cholesterol embolism, sometimes fatal, has been reported rarely in patients treated with thrombolytic agents.

Coagulation Tests May be Unreliable during Activase Therapy

Coagulation tests and/or measures of fibrinolytic activity may be unreliable during Activase therapy.

Adverse Reactions

The most frequent adverse reaction associated with Activase AMI therapy is bleeding.

Allergic type reactions, e.g., anaphylactoid reaction, laryngeal edema, orolingual angioedema, rash, and urticaria have been reported.

ACTIVASE (PE)

Indication: Pulmonary Embolism

Activase® is indicated for the lysis of acute massive pulmonary embolism (PE), defined as:

— Acute pulmonary emboli obstructing blood flow to a lobe or multiple lung segments

— Acute pulmonary emboli accompanied by unstable hemodynamics, e.g., failure to maintain blood pressure without supportive measures

Important Safety Information

Contraindications

Do not administer Activase to treat pulmonary embolism in the following situations in which the risk of bleeding is greater than the potential benefit: active internal bleeding; history of recent stroke; recent (within 3 months) intracranial or intraspinal surgery or serious head trauma; presence of intracranial conditions that may increase the risk of bleeding; bleeding diathesis; and current severe uncontrolled hypertension.

Warnings and Precautions

Bleeding

Activase can cause internal or external bleeding. Avoid intramuscular injections and trauma to the patient. Fatal cases of hemorrhage associated with traumatic intubation in patients administered Activase have been reported. Heparin, aspirin, or Activase may cause bleeding complications; therefore carefully monitor for bleeding. If serious bleeding occurs, terminate the Activase infusion.

Orolingual Angioedema

Monitor patients during and for several hours after infusion for orolingual angioedema. If angioedema develops, discontinue the Activase infusion and promptly institute appropriate therapy.

Cholesterol Embolization

Cholesterol embolism, sometimes fatal, has been reported rarely in patients treated with thrombolytic agents.

Reembolization of Deep Venous Thrombi during Treatment for Acute Massive Pulmonary Embolism

Consider the possible risk of reembolization due to the lysis of underlying deep venous thrombi patients with acute massive PE.

Coagulation Tests May be Unreliable during Activase Therapy

Coagulation tests and/or measures of fibrinolytic activity may be unreliable during Activase therapy.

Adverse Reactions

The most frequent adverse reaction associated with Activase PE therapy is bleeding.

Allergic type reactions, e.g., anaphylactoid reaction, laryngeal edema, orolingual angioedema, rash, and urticaria have been reported.

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