Frequently asked questions about Cathflo

	What is Cathflo?
	Cathflo is a thrombolytic agent that gives you a viable treatment option for central venous access device (CVAD) occlusions. It is a human tissue plasminogen activator (t-PA) produced by recombinant DNA technology. In the clinical trials, the most serious adverse events reported after treatment were sepsis, gastrointestinal bleeding, and venous thrombosis.
	What is Cathflo indicated for?
	Cathflo is indicated for the restoration of function to CVADs, as assessed by the ability to withdraw blood.
	What is the billing code for Cathflo?
	The billing code, or J code, for Cathflo is J2997, often listed under the generic name Alteplase. This billing code is associated with a 1-mg billing unit.
	Are there other thrombolytic agents that are FDA approved and marketed for treating an occluded catheter?
	No. Cathflo is the only marketed FDA-approved thrombolytic agent indicated for the restoration of function to central venous access devices (CVADs) as assessed by the ability to withdraw blood.
	How does Cathflo work?
	Cathflo works by converting plasminogen to plasmin, which dissolves fibrin (a substance that causes blood to clot), breaking down the thrombus and restoring function to the CVAD.
	What are the potential benefits of the high-fibrin specificity of Cathflo?
	As with native t-PA, Cathflo is highly fibrin-specific. It therefore acts specifically on fibrin-rich clots in the occluded catheter. The clinical significance of fibrin specificity is unknown.
	How efficacious is Cathflo?
	Cathflo has proven efficacy. In the COOL-1 trials, Cathflo demonstrated an 88% cumulative efficacy after up to 2 doses using a 2-hour dwell. In the COOL-2 trials, Cathflo demonstrated an 85% cumulative efficacy after up to 2 doses using a 2-hour dwell. *Study design: COOL-1, a multicenter, double-blind, placebo-controlled comparison of the rates of restoration of catheter function after treatment for 2 hours with either alteplase 2 mg in 2 mL or placebo (N=150). COOL-2, an open-label, single-arm, multicenter trial in which 995 patients received treatment with up to 2 doses of Cathflo 2 mg using a 2-hour dwell.
	What is the efficacy and safety profile for the pediatric patient?
	Cathflo's efficacy and safety profile in pediatric patients in the Cathflo Pediatric Study (CAPS) demonstrated an 83% cumulative efficacy after up to 2 doses using a 2-hour dwell. Rates of adverse events were similar in pediatric and adult patients. Cathflo was studied in patients between 2 weeks and 17 years of age.1 *Study design: CAPS, a prospective, multicenter, open-label, single-arm study where two maximum does of 2 mg of alteplase was performed in patients between the age of 2 weeks and 17 with occluded catheters (N=310).
	What is the safety profile of Cathflo?
	Adverse events seen in the largest clinical trial involving Cathflo included sepsis (0.4%), major hemorrhage (0.4%), gastrointestinal bleeding (0.3%), and venous thrombosis (0.3%).2,3 There were no instances of intracranial hemorrhage (ICH) or embolic events. Cathflo should not be administered to patients with known hypersensitivity to Alteplase or any component of the formulation. It should be used with caution in the presence of known or suspected infections in the catheter. Using Cathflo in patients with infected catheters may release a localized infection into the systemic circulation.
	Are Cathflo levels high enough in concentration to produce system pharmacological response?
	Cathflo limits systemic exposure because it works by dwelling in the cathether in direct contact with the clot. Although a small quantity may enter the bloodstream, the circulating plasma levels are not expected to reach concentrations that produce systemic pharmacological responses, and this is partly due to its short half-life. If a 2-mg dose of Cathflo was administered by bolus injection into the circulation, the concentration of circulating drug would be expected to return to endogenous levels of 5 to 10 ng/ml within 30 minutes.

N=995; patients received a 2- to 4-mg cumulative dose of Cathflo.

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.

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

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References:

Blaney M, Shen V, Kerner J, et al, 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.
Ponec D, Irwin D, Haire WD, et al. Recombinant tissue plasminogen activator (alteplase) for restoration of flow in occluded central venous access devices: a double-blind placebo-controlled trial — the cardiovascular thrombolytic to open occluded lines (COOL) efficacy trial. J Vasc Interv Radiol. 2001;12:951-955.
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.