Cathflo® Activase® (alteplase) 2–mg vial of t–PA

FDA-approved and marketed for restoration of CVAD function that is compromised by thrombotic occlusion
Available in a single-use, 2-mg vial
Efficacy and safety profile in adult and pediatric patients5,6

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.

Please see full Prescribing Information for additional important safety information.

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References:

Stephens LC, Haire WD, Kotulak GD. Are clinical signs accurate indicators of the cause of central venous catheter occlusion? JPEN Parenter Enteral Nutr. 1995;19(1):75-79.
National Institutes of Health. Management of central venous catheter occlusions. Pharm Update. 1999:1-4.
Hadaway LC. Reopen the pipeline for I.V. therapy. Nursing. 2005;35(8):54-61.
Mayo DJ, Pearson DC. Chemotherapy extravasation: a consequence of fibrin sheath formation around venous access devices. Oncol Nurs Forum. 1995;22(4):675-680.
Deitcher SR, Fesen MR, Kiproff PM, et al, for the Cardiovascular Thrombolytic to Open Occluded Lines-2 Investigators. Safety and efficacy of alteplase for restoring function in occluded central venous catheters: results of the Cardiovascular Thrombolytic to Open Occluded Lines trial. J Clin Oncol. 2002;20:317-324.
Blaney M, Shen V, Kerner JA, for the CAPS Investigators. Alteplase for the treatment of central venous catheter occlusion in children: results of a prospective, open-label, single-arm study (the Cathflo Activase Pediatric Study). J Vasc Interv Radiol. 2006;17:1745-1751.