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

Indication and Important Safety Information

Activase is indicated for the lysis of acute massive PE, defined as5

  • Acute pulmonary emboli obstructing blood flow to a lobe or multiple lung segments.
  • Acute pulmonary emboli accompanied by unstable hemodynamics, that is, 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; bleeding diathesis; and current severe uncontrolled hypertension.
 

Warnings and Precautions
 

Bleeding
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.

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 in this setting.

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.

Review Activase for acute massive PE Clinical Overview >