Side Effect Reporting
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.
You may also report side effects to Genentech at (888) 835-2555.
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Indication
Cathflo® Activase® (Alteplase) is indicated for the restoration of function to central venous access devices 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 (i.e. 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.
Please see full Prescribing Information at www.cathflo.com for additional important safety information.