Activase® is considered the standard treatment for eligible patients with acute massive Pulmonary Embolism (PE) 33,34

Indication and Important Safety Information

Activase is indicated for the lysis of acute massive PE, defined as6

  • 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.
     

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 (e.g., some neoplasms, arteriovenous malformations, or aneurysms); bleeding diathesis; and current severe uncontrolled hypertension.
 

Warnings and Precautions
 

Bleeding

Activase can cause significant, sometimes fatal internal or external bleeding. Avoid intramuscular injections and trauma to the patient. Perform venipunctures carefully and only as required. 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, and treat properly.

Hypersensitivity

Hypersensitivity, including urticarial / anaphylactic reactions, have been reported. Rare fatal outcome for hypersensitivity was reported. Monitor patients treated during and for several hours after infusion for hypersensitivity. If signs of hypersensitivity occur, e.g. anaphylactoid reaction or angioedema develops, discontinue Activase and promptly institute appropriate therapy (e.g., antihistamines, intravenous corticosteroids, epinephrine).

Thromboembolism

The use of thrombolytics can increase the risk of thrombo-embolic events in patients with high likelihood of left heart thrombus, such as patients with mitral stenosis or atrial fibrillation. Activase has not been shown to treat adequately underlying deep vein thrombosis in patients with PE. Consider the possible risk of re-embolization due to the lysis of underlying deep venous thrombi in this setting.

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.


Please see full Prescribing Information for additional Important Safety Information.

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