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Product Indications and Important Safety Information

Cathflo Activase (Alteplase) for CVADs

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

Important Safety Information
Cathflo Activase should not be administered to patients with known hypersensitivity to Alteplase or any component of the formulation.

In clinical trials, the most serious adverse events reported after treatment were sepsis, gastrointestinal bleeding, and venous thrombosis.

Certain causes of catheter dysfunction should be considered before treatment with Cathflo Activase (ie, catheter malposition, mechanical failure, constriction by a suture and lipid deposits or drug precipitates within the catheter lumen).

The most frequent adverse reaction associated with all thrombolytics in all approved indications is bleeding. Caution should be exercised with patients who have any condition for which bleeding constitutes a significant hazard.

Cathflo Activase should be used with caution in the presence of known or suspected infection in the catheter.

Activase (Alteplase) for Stroke

Indication
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).

Important Safety Information
Activase therapy in patients with AIS is contraindicated in certain situations (eg, suspicion of subarachnoid hemorrhage on pretreatment evaluation, recent (within 3 months) intracranial or intraspinal surgery, history of intracranial hemorrhage, uncontrolled hypertension at time of treatment, active internal bleeding, known bleeding diathesis (eg, current use of oral anticoagulants, administration of heparin within 48 hours of onset of stroke, platelet count <100,000) (see CONTRAINDICATIONS for full list).

The most common complication during Activase therapy is bleeding. Should serious bleeding in a critical location (intracranial, gastrointestinal, retroperitoneal, pericardial) occur, Activase therapy should be discontinued immediately. Death and permanent disability are not uncommonly reported in patients who have experienced stroke (including intracranial bleeding) and other serious bleeding episodes.

The risks of Activase therapy may be increased and should be weighed against the anticipated benefits in certain conditions. [See WARNINGS in full prescribing information].

Patients with severe neurological deficit (eg, NIHSS >22) at presentation. There is an increased risk of intracranial hemorrhage in these patients.
Patients with major early infarct signs on a computerized cranial tomography (CT) scan (eg, substantial edema, mass effect, or midline shift).

Treatment of patients with minor neurological deficit or with rapidly improving symptoms is not recommended.

Orolingual angioedema has been observed in postmarketing experience in patients treated with Activase for AIS. Patients should be monitored during and for several hours after infusion for signs of orolingual angioedema.

TNKase (Tenecteplase) for AMI

Indication
For use in mortality reduction associated with acute myocardial infarction (AMI). Treatment should be initiated as soon as possible after the onset of symptoms.

Important Safety Information
TNKase therapy in patients with acute myocardial infarction is contraindicated in the following certain situations (eg, active internal bleeding, history of cerebrovascular accident, known bleeding diathesis, severe uncontrolled hypertension) because of an increased risk of bleeding [See CONTRAINDICATIONS in full prescribing information].

The most common complication encountered during TNKase therapy is bleeding. Should serious bleeding (not controlled by local pressure) occur, any concomitant heparin or antiplatelet agents should be discontinued immediately.

In certain conditions (eg, recent major surgery, cerebrovascular disease, hypertension) the risk of TNKase therapy may be increased and should be weighed against the anticipated benefits. [See WARNINGS in full prescribing information].

Cholesterol embolism has been reported rarely in patients treated with all types of thrombolytic agents; the true incidence is unknown.

Coronary thrombolysis may result in arrhythmias associated with reperfusion. It is recommended that anti-arrhythmic therapy for bradycardia and/or ventricular irritability be available when TNKase is administered.

Activase (Alteplase) for AMPE

Indication
Activase (Alteplase) is indicated in the management of acute massive pulmonary embolism (AMPE) in adults: (1) for the lysis of acute pulmonary emboli, defined as obstruction of blood flow to a lobe or multiple segments of the lungs; (2) 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 noninvasive procedures such as lung scanning.

Important Safety Information
Activase therapy in patients with acute massive pulmonary embolism (AMPE) is contraindicated in certain situations because of an increased risk of bleeding (eg, active internal bleeding, history of cerebrovascular accident, recent intracranial or intraspinal surgery or trauma, severe uncontrolled hypertension) [See CONTRAINDICATIONS in the full prescribing information].

The risks of Activase therapy for all approved indications may be increased and should be weighed against the anticipated benefits in certain conditions [See WARNINGS in full prescribing information].

Treatment of AMPE with Activase has not been shown to constitute adequate clinical treatment of underlying deep vein thrombosis. The possible risk of reembolization due to the lysis of underlying deep venous thrombi should be considered.

View Cathflo Activase full Prescribing Information

View Activase full Prescribing Information

View TNKase full Prescribing Information

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