Cathflo® Activase® (alteplase) Administration

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Allow appropriate Cathflo dwell time before assessing catheter function

Review these general guidelines for administering Cathflo8

Cathflo Administration

After WASHING hands and applying gloves8:

Three images showing reconstitution of Cathflo

1. After reconstitution using 2.2 mL sterile water for injection and aseptic technique INSPECT solution for foreign matter and discoloration.

Gloved hands instilling Cathflo into occluded catheter using a syringe

2. INSTILL the appropriate dose of Cathflo into the occluded catheter using a 10-mL syringe (see dosing chart).

Administration taking place with a graphic showing 30 minutes of dwell time

3. After 30 minutes of DWELL time, assess the catheter function by attempting to aspirate blood. If the catheter is functional, go to the last step; if not functional, go to the next step.

Gloved hand assessing catheter function with a graphic showing 120 minutes of dwell time

4. ASSESS catheter function after a total of 120 minutes of dwell time by attempting to aspirate blood. If catheter is functional, go to the next step. If catheter is still occluded, a second dose of equal amount may be instilled. Repeat reconstitution and administration steps.

Gloved hands aspirating blood to remove Cathflo and residual clot

5. If catheter function has been restored, ASPIRATE 4 to 5 mL of blood in patients ≥10 kg or 3 mL in patients <10 kg to remove Cathflo and residual clot. Then discard aspirate and flush the catheter with 0.9% Sodium Chloride, USP. Any unused solution should be discarded.

Cathflo® Instructional Video on Dosing and Administration for Partial Occlusions

Cathflo® Instructional Video on Dosing and Administration for Partial Occlusions

A short video that provides visual and audio instructions on how to properly dose and administer Cathflo for a partial occlusion (ability to infuse but not withdraw fluids, or the presence of sluggish flow).

Cathflo® Instructional Video on Dosing and Administration for Complete Occlusions

Cathflo® Instructional Video on Dosing and Administration for Complete Occlusions

A short video that provides visual and audio instructions on how to properly dose and administer Cathflo for a complete occlusion (inability to infuse or aspirate)

Bottle

The INS Infusion Therapy Standards of Practice state that the instillation of alteplase 2 mg (Cathflo Activase) is safe and effective in restoring catheter patency in patients.2

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.

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