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Product Indication Statements

Cathflo Activase (Alteplase) is indicated for restoration of function to central venous access devices as assessed by the ability to withdraw blood.

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 (see CONTRAINDICATIONS in the full prescribing information).

TNKase (Tenecteplase) is indicated for use in the reduction of mortality associated with acute myocardial infarction (AMI). Treatment should be initiated as soon as possible after the onset of AMI symptoms.

Activase is also indicated in the management of acute massive pulmonary embolism (AMPE) 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, eg, failure to maintain blood pressure without supportive measures. The diagnosis should be confirmed by objective means, such as pulmonary angiography or lung scanning.

Important Safety Information

Cathflo Activase Safety Information: Cathflo Activase should not be administered to patients with known hypersensitivity to Alteplase or any component of the formulation.
In the clinical trials, the most serious adverse events reported after treatment were sepsis, gastrointestinal bleeding, and venous thrombosis. Cathflo Activase should be used with caution in the presence of known or suspected infections in the catheter.

Activase Safety Information for Acute Ischemic Stroke: All thrombolytic agents increase the risk of bleeding, including intracranial bleeding, and should be used only in appropriate patients. Not all patients with acute ischemic stroke will be eligible for Activase therapy, including patients with evidence of recent or active bleeding; recent (within 3 months) intracranial or intraspinal surgery, serious head trauma, or previous stroke; uncontrolled high blood pressure; or impaired blood clotting.

TNKase Safety Information: TNKase therapy is contraindicated in the following conditions due to an increased risk of bleeding: active internal bleeding, history of cerebrovascular accident, intracranial or intraspinal surgery or trauma within 2 months, intracranial neoplasm, arteriovenous malformation, or aneurysm, known bleeding diathesis, and severe uncontrolled hypertension.

All thrombolytic agents increase the risk of bleeding, including intracranial bleeding, and should be used only in eligible patients. In addition, thrombolytic therapy increases the risk of stroke, including hemorrhagic stroke, particularly in elderly patients. In patients with large ST segment elevation myocardial infarction, physicians should choose either thrombolysis or percutaneous coronary intervention (PCI) as the primary treatment strategy for reperfusion.

Activase Safety Information for Acute Massive Pulmonary Embolism: All thrombolytic agents increase the risk of bleeding, including intracranial bleeding. Not all patients will be eligible for Activase therapy, including those patients in the following situations, because of an increased risk of bleeding: active internal bleeding; history of cerebrovascular accident; recent intracranial or intraspinal surgery or trauma (see WARNINGS in full prescribing information); intracranial neoplasm, arteriovenous malformation, or aneurysm; known bleeding diathesis; or severe uncontrolled hypertension.

View Cathflo Activase full Prescribing Information

View Activase full Prescribing Information

View TNKase full Prescribing Information