Standard of Care

Cathflo® Activase® (alteplase) is the standard of care for treatment of thrombotically occluded catheters

Use Cathflo as approved by the FDA

Cathflo is the only FDA-approved thrombolytic agent1-8,23:

  • Used for the restoration of function to central venous access devices (CVADs) as assessed by the ability to withdraw blood2
  • Recommended by clinical practice standards, including1,3-7:
    • Infusion Nurses Society (INS)
    • Association for Vascular Access (AVA)
    • American Association of Critical Care Nurses (AACN)
    • Oncology Nursing Society (ONS)
  • That is available in a single-use 2 mg vial; it is not recommended that it be compounded, frozen or thawed8
  • With an efficacy and safety profile demonstrated in pediatric and adult patients

Key societies that support using Cathflo Activase (alteplase) to restore function to CVADs:

INS

Infusion Nurses Society
  • Instillation of alteplase (Cathflo Activase) based on manufacturers' directions for use is recommended in current guidelines1 
  • Randomized controlled trials are required to determine the efficacy of alternate dosing1

Class 1; Level of evidence A. INS Infusion Therapy Standards of Practice, 2021, page S151, standard 49, practice F

CDC Guideline for Isolation Precautions, 2007, page 83, section IV.H.5

AVA

Association for Vascular Access
  • Alteplase 2 mg (Cathflo Activase) is the only FDA-approved thrombolytic agent for the treatment of dysfunctional CVADs6

AVA Resource Guide for Vascular Access, Association for Vascular Access, Second Edition, 2021, page 78

AACN

American Association of Critical-Care Nurses

"Declotting is done with 2 mg of tPA [alteplase, Cathflo Activase]."
— AACN Critical Care Nurse, 2007

ONS

Oncology Nursing Society
  • Use 2 mg alteplase (Cathflo Activase) to restore patency and maintain catheter function3

Practice Standard B (Level 1). ONS Access Device Standards of Practice, 2017, page 10, Section VI, practice standard B

See the Resource Center for other catheter management resources and organizations.

Genentech neither is affiliated with nor endorses the above organizations.

Bottle

The only thrombolytic agent FDA-approved for adult and pediatric patients, Cathflo Activase (alteplase) has the highest level of evidence regarding the treatment of thrombotic occlusions (INS, Class 1, Level of evidence A; ONS Practice Standard, Level 1).1,3,23

Explore the full prescribing information, including the Important Safety Information >

NEXT: Review the efficacy and safety profile of Cathflo
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Important Safety Information

Indication

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

Contraindications

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

Precautions

General

Certain causes of catheter dysfunction should be considered before treatment with Cathflo Activase (e.g. 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.

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 (e.g., intracranial, gastrointestinal, retroperitoneal, pericardial) occur, treatment with Cathflo Activase should be stopped and the drug should be withdrawn from the catheter.

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.

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.

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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

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

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.

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 accompanying full Prescribing Information for additional Important Safety Information.

    • Infusion Nurses Society. Infusion therapy standards of practice. J Infus Nurs. 2021:44(suppl 1):S1-S224.

      Infusion Nurses Society. Infusion therapy standards of practice. J Infus Nurs. 2021:44(suppl 1):S1-S224.

    • Blaney M, Shen V, Kerner JA, et al; for 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(11, pt 1):1745-1751.

      Blaney M, Shen V, Kerner JA, et al; for 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(11, pt 1):1745-1751.

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    • Cathflo Prescribing Information. Genentech USA, Inc.

      Cathflo Prescribing Information. Genentech USA, Inc.

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    • 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(1):317-324.

      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(1):317-324.

    • Doellman D, Buckner JK, Garrett JH Jr, et al. Best practice guidelines in the care and maintenance of pediatric central venous catheters. 2015. http://www.ivas.online/newstyle/wp-content/uploads/2019/06/AVA-Pediatric-Guidelines-2nd-edition_web.pdf

      Doellman D, Buckner JK, Garrett JH Jr, et al. Best practice guidelines in the care and maintenance of pediatric central venous catheters. 2015. http://www.ivas.online/newstyle/wp-content/uploads/2019/06/AVA-Pediatric-Guidelines-2nd-edition_web.pdf

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    • 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 Inter Radiol. 2001;12(8):951-955.

      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 Inter Radiol. 2001;12(8):951-955.

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