Speaker 1:

00:01 Welcome to the Cathflo Proposed Mechanism of Action video. This video will demonstrate how Cathflo works and how it plays a key role in helping to restore function to catheters with thrombotic occlusions.

Speaker 2:

00:15 Indication

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

00:26 Important Safety Information; Contraindications

Cathflo Activase should not be administered to patients with known hypersensitivity to alteplase or any component of the formulation. 

00:37 Precautions; General

Certain causes of catheter dysfunction should be considered before treatment with Cathflo Activase. For example, catheter malposition, mechanical failure, constriction by a suture, and lipid deposits or drug precipitates within the catheter lumen. These types of conditions should be considered before treatment with Cathflo Activase. 

Please stay tuned for additional important safety information.

Speaker 1:

01:03 Central venous access devices, or CVADs, are essential in the management of patients undergoing complex and intensive therapies in both inpatient and outpatient settings. 

01:17 Catheters can be used either short or long term for the infusion of parenteral nutrition, chemotherapy or other vesicant or irritating solutions, blood and blood products, antibiotics, medication or solutions in patients with limited peripheral access, or therapy that is ongoing or continued at home.

01:46 When a CVAD is inserted into a blood vessel, the catheter surface becomes coded with fibrin and other circulating plasma proteins. Over time, fibrin along with platelets and red blood cells can form an occlusion within the catheter lumen, at the insertion site, on the external surface, or most commonly at its tip. 

02:10 One in 4 catheters may become occluded. Of these occlusions, about 58% of them are thrombotic. There are 4 common types of catheter occlusions. An intraluminal thrombus can form within the catheter lumen. 

02:32 A fibrin tail forms when fibrin adheres to the catheter tip. This tail can act as a one-way valve permitting infusion, but not withdrawal of fluid or blood. A mural thrombus forms when the fibrin from a vessel wall injury binds to the fibrin, covering the catheter surface.

A fibrin sheath forms when fibrin adheres to the external surface of the catheter, covering it like a sock. Any of these occlusions can interrupt administration of medications and solutions. Catheter occlusions can be partial or complete. In a partial occlusion, infusion is possible, but aspiration is not. With a complete occlusion, neither infusion nor aspiration is possible through the catheter. Flushing the line is not enough. You must be able to withdraw blood to rule out a partial occlusion before administering critical therapies. 

Cathflo 2 milligrams in 2 milliliters is the only FDA-approved thrombolytic agent for the restoration of function to CVADs as assessed by the ability to withdraw blood.

3:52 Please note for patients weighing less than 30 kilograms, the FDA-approved dose is 110% of the internal lumen volume of the CVAD, not to exceed 2 milligrams in 2 milliliters. 

Cathflo, supplied as a single use, 2 milligram vial, helps to dissolve thrombotic occlusions within CVADs and restore catheter function as assessed by the ability to withdraw blood. Cathflo, 2 milligrams in 2 milliliters, is instilled into the catheter lumen and allowed to dwell for up to 120 minutes. It is critical to use the dose of Cathflo as approved by the FDA. An assessment of function may be made after 30 minutes.

4:43 If catheter function is not restored at 120 minutes after one dose of Cathflo Activase, a second dose may be instilled. 

There is no efficacy or safety information on dosing in excess of 2 milligrams per dose for this indication. Randomized controlled clinical studies have not been performed with administration of total doses greater than 4 milligrams; 2, 2 milligram doses; or less than 2 milligrams in 2 milliliters. Cathflo is a thrombolytic specifically developed to target and help dissolve the fibrin within the clot. 

5:28 Cathflo binds to fibrin in a thrombus, converting entrapped plasminogen to active enzyme plasmin, thereby initiating local fibrinolysis. The clot is then dissolved, and any residual debris can be aspirated from the catheter, restoring central venous access. The proposed fibrin-specific mechanism of action of Cathflo addresses the root cause of thrombotic occlusions. The 2 milligram dose of Cathflo is not expected to reach pharmacologic levels in systemic circulation. The clinical significance of fibrin specificity is unknown.

Speaker 2:

06:10 Indication

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

06:21 Important Safety Information; Contraindications  

Cathflo Activase should not be administered to patients with known hypersensitivity to alteplase or any component of the formulation.

06:33 Precautions; General

Certain causes of catheter dysfunction should be considered before treatment with Cathflo Activase. For example, catheter malposition, mechanical failure, constriction by a suture, and lipid deposits or drug precipitates within the catheter lumen. These types of conditions should be considered before treatment with Cathflo Activase. Excessive pressure should be avoided when Cathflo Activase is instilled into the catheter. Such force could cause rupture of the catheter or expulsion of the clot into the circulation. 

07:05 Bleeding

The most frequent adverse reaction associated with all thrombolytics in all approved indications is bleeding. Cathflo Activase has not been studied in patients known to be at risk for bleeding events that may be associated with the use of thrombolytics. Caution should be exercised with patients who have any condition for which bleeding constitutes a significant hazard. Should serious bleeding in a critical location—for example, intracranial, gastrointestinal, retroperitoneal, pericardial—occur, treatment with Cathflo Activase should be stopped, and the drug should be withdrawn from the catheter. 

07:44 Infections

Cathflo Activase should be used with caution in the presence of known or suspected infection in the catheter. Using Cathflo Activase in patients with infected catheters may release a localized infection into the systemic circulation. As with all catheterization procedures, care should be used to maintain aseptic technique.

08:05 Hypersensitivity

Hypersensitivity, including urticaria, angioedema, and anaphylaxis has been reported in association with use of Cathflo Activase. Monitor patients treated with Cathflo Activase for signs of hypersensitivity and treat appropriately if necessary.

08:23 Drug Interactions and Drug Laboratory Test Interactions

The interaction of Cathflo Activase with other drugs has not been formally studied. Concomitant use of drugs affecting coagulation and/or platelet function has not been studied. Potential interactions between Cathflo Activase and laboratory tests have not been studied. 

08:44 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate the carcinogenic potential or the effect on fertility.

08:54 Pregnancy

There are no adequate and well-controlled studies in pregnant women. Cathflo Activase should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

09:07 Adverse Reactions

In clinical trials, the most serious adverse events reported after treatment were sepsis, gastrointestinal bleeding, and venous thrombosis. 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. Please see full prescribing information for additional important safety information.

Speaker 1:

09:40 Cathflo 2 milligrams in 2 milliliters is the standard of care for treatment of thrombotically occluded catheters. Cathflo 2 milligrams is the only FDA approved thrombolytic agent for the restoration of function to CVADs as assessed by the ability to withdraw blood. Cathflo is the only thrombolytic supported by clinical practice standards, including the Infusion Nurses Society, Association for Vascular Access, American Association of Critical Care Nurses, and Oncology Nursing Society. For more information, please visit www.cathflo.com.