Activase® is an effective treatment option for Acute Myocardial Infarction (AMI)

Indication and Important Safety Information

Activase is indicated for use in AMI for the reduction of mortality and reduction of the incidence of heart failure.5

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.5

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

Activase can cause significant, sometimes fatal, internal or external bleeding, especially at arterial and venous puncture sites. 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 therapy is bleeding.

Although exploratory analyses of the AIS clinical studies suggest that severe neurological deficit (National Institutes of Health Stroke Scale [NIHSS > 22]) at presentation was associated with an increased risk of intracranial hemorrhage, efficacy results suggest a reduced but still favorable clinical outcome for these patients.

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

Please see full Prescribing Information for additional Important Safety Information.

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