Cathflo® Activase® (alteplase) Administration

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

Speaker 1:

00:05 Indication

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

00:18 Select Important Safety Information; Contraindications

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

00:32 Precaution; 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. Please stay tuned for additional important safety information immediately following this presentation. 

1:16 Welcome to the Cathflo reconstitution and dosing video. This video will review the reconstitution and administration of Cathflo for partial occlusions. The safety and efficacy of Cathflo were studied using the 2-milligram dose, and Cathflo was FDA approved based on a 2 milligram dosage. For pediatric 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 and 2 milliliters. When Cathflo Activase is administered for restoration of function to central venous access devices, according to the instructions in dosage and administration, circulating plasma levels of alteplase are not expected to reach pharmacologic concentration.

02:05 Each time you administer Cathflo, use a single use 2 milligram vial per lumen and consult the dosing chart. If catheter function is not restored at 120 minutes after 1 dose of Cathflo, a second dose may be instilled. Studies only evaluated up to 2, 2 milligram doses. The 2016 INS Infusion Therapy Standards of Practice state “CVAD occlusions should not be left untreated because another lumen is patent.” Before administering Cathflo, consult your institution's policy and procedures since administration techniques may vary.

02:44 To prepare Cathflo, you will need the vial of lyophilized Cathflo, a 10-milliliter syringe or a syringe specifically designed to generate lower injection pressure, sterile water for injection USP, and a septic cleanser and gloves. Store lyophilized Cathflo at a refrigerated temperature of 2 to 8 degrees Celsius or 36 to 46 degrees Fahrenheit. To prepare Cathflo, use aseptic technique.

03:27 Then withdraw 2.2 milliliters of sterile water for injection USP. Diluent is not provided and if necessary, should be ordered from the pharmacy. Do not use bacteriostatic water for injection. Reconstitute to 2 milligrams in 2 milliliters. Next, inject the 2.2 milliliters of sterile water for injection USP into the Cathflo vial, directing the diluent stream into the powder. Slight foaming is not unusual. Let the vial stand undisturbed to allow large bubbles to dissipate.

04:04 Then mix by gently swirling until the contents are completely dissolved. Complete dissolution should occur within 3 minutes. Do not shake. The reconstituted preparation results in a colorless to pale yellow transparent solution at a pH of approximately 7.3. Cathflo contains no antibacterial preservatives and should be reconstituted immediately before use. However, the solution is recommended to be used for intracatheter instillation within 8 hours following reconstitution when stored at 2 to 30 degrees Celsius, 36 to 86 degrees Fahrenheit. The unreconstituted vial with lyophilized powder should also be stored under refrigeration. 

04:53 Now, let's review the standard instillation of Cathflo for a partial occlusion. Immediately before use, inspect the reconstituted Cathflo for foreign matter and discoloration. To instill Cathflo for a partial occlusion, aseptically withdraw 2 milliliters, 2 milligrams of reconstituted solution from the vial.

05:23 Before attaching the syringe, scrub the hub, apply vigorous friction to the catheter hub for 10 to 15 seconds. Then allow the hub to dry. Make sure to prevent it from touching anything while drying. Instill the appropriate dose of Cathflo into the occluded catheter using a 10-milliliter syringe or a syringe specifically designed to generate lower injection pressure.

05:52 After 30 minutes of dwell time, assess the catheter function by attempting to aspirate blood. If function has not been restored, allow Cathflo to dwell for a total of 120 minutes. Then reassess function by once again attempting to aspirate blood.

06:14 If the catheter is still occluded, a second dose of equal amount may be instilled with 30 and 120 minute assessments done. If catheter function is not restored after 2 serial doses of Cathflo, the physician should be notified, and further catheter management strategies should be discussed. There is no efficacy or safety information on dosing in excess of 2 milligrams per dose for this indication. If catheter function is restored at any assessment, aspirate 4 milliliters to 5 milliliters of blood in patients greater than or equal to 10 kilograms in weight or 3 milliliters in patients less than 10 kilograms in weight to remove Cathflo and residual clot.

07:00 With a new 10-milliliter syringe or a syringe specifically designed to generate lower injection pressure, use a pulsatile flush or push-pause technique to irrigate the catheter with 0.9% sodium chloride USP. Any unused solution should be discarded. You may then proceed with administering therapy as planned. 

07:34 Indication

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

07:47 Important Safety Information; Contraindications

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

08:00 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.

08:36 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.

09:15 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.

09:40 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.

09:59 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.

10:23 Carcinogenesis, Mutagenesis, Impairment of Fertility

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

10:35 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.

10:49 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 Cathflo full prescribing information for important safety information. For more information about Cathflo visit Cathflo.com.

Cathflo® Instructional Video on Dosing and Administration for Complete Occlusions

Speaker 1:

00:05 Indication

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

00:18 Select Important Safety Information; Contraindications 

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

00:32 Precaution; 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. Please stay tuned for additional important safety information immediately following this presentation.

01:16 Welcome to the Cathflo Reconstitution and Dosing video. This video will review the reconstitution and administration of Cathflo for complete occlusions. The safety and efficacy of Cathflo were studied using the 2 milligram dose and Cathflo was FDA-approved based on a 2 milligram dosage. For pediatric 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. When Cathflo Activase is administered for restoration of function to central venous access devices, according to the instructions in dosage and administration, circulating plasma levels of alteplase are not expected to reach pharmacologic concentrations. Each time you administer Cathflo, use a single-use 2 milligram vial per lumen, and consult the dosing chart. If catheter function is not restored at 120 minutes after 1 dose of Cathflo, a second dose may be instilled. Studies only evaluated up to 2, 2 milligram doses. The 2016 INS Infusion Therapy Standards of Practice state, "CVAD occlusions should not be left untreated because another lumen is patent." Before administering Cathflo, consult your institution's policy and procedures, since administration techniques may vary.

02:43 To prepare Cathflo, you will need the vial of Lyophilized Cathflo, a 10-milliliter syringe, or a syringe specifically designed to generate lower injection pressure, sterile water for injection USP and a septic cleanser and gloves. Store Lyophilized Cathflo at a refrigerated temperature of 2 to 8 degrees Celsius, or 36 to 46 degrees Fahrenheit. To prepare Cathflo, use aseptic technique.

03:26 Then withdraw 2.2 milliliters of sterile water for injection USP. Diluent is not provided and if necessary, should be ordered from the pharmacy. Do not use Bacteriostatic Water for injection. Reconstitute to 2 milligrams in 2 milliliters. Next, inject the 2.2 milliliters of sterile water for injection USP, into the Cathflo vial, directing the diluent stream into the powder. Slight foaming is not unusual. Let the vial stand undisturbed to allow large bubbles to dissipate.

4:04 Then mix, by gently swirling until the contents are completely dissolved. Complete dissolution should occur within 3 minutes. Do not shake. The reconstituted preparation results in a colorless to pale yellow transparent solution, at a pH of approximately 7.3. Cathflo contains no antibacterial preservatives and should be reconstituted immediately before use. However, the solution is recommended to be used for intracatheter instillation within 8 hours following reconstitution, when stored at 2 to 30 degrees Celsius, 36 to 86 degrees Fahrenheit. The unreconstituted vial with lyophilized powder, should also be stored under refrigeration. Now, let's review the instillation of Cathflo using negative pressure with 1 syringe and the 3-way stopcock method for complete occlusions. Immediately before use, inspect the reconstituted Cathflo for foreign matter and discoloration. To instill Cathflo using the 3-way stopcock method, first aseptically remove the cap and attach the Luer lock end of the 3-way stopcock to the catheter, making sure the stopcock is in the off position.

05:23 Next, attach an empty syringe to 1 of the ports on the stopcock. Attach the syringe containing Cathflo to the remaining port on the stopcock, and then turn the stopcock off to the syringe containing Cathflo. Gently aspirate the catheter using the empty syringe until the plunger is pulled back to the 8 to 9 milliliter mark. Then turn the stopcock off to the empty syringe. This will allow Cathflo to be drawn into the central line. Repeat the negative pressure technique with the Cathflo syringe, until the entire dose is drawn into the catheter. Depending on the size of the occlusion, this may take some time, be patient instilling. As Cathflo interfaces with the clot, it will dissolve at the point of connection. Each time you repeat negative pressure, it will agitate the fluid, allowing for new clot surface to contact Cathflo. Never repeat aspiration on the empty syringe, as it will aspirate Cathflo out of the lumen. Once the entire dose of Cathflo has been instilled, turn the stopcock off to the patient. Cathflo should now be allowed to dwell within the catheter lumen for 30 to 120 minutes.

06:38 After 30 minutes of dwell time, assess the catheter function, by attempting to aspirate blood. Blood return should be the color and consistency of whole blood. If function has not been restored, allow Cathflo to dwell for a total of 120 minutes, then reassess function by once again, attempting to aspirate blood. Consider that the potential for contamination exists with all add-on devices. According to the 2016 INS Infusion Therapy Standards of Practice, you should limit the use of add-on devices whenever possible, to decrease the number of manipulation episodes, accidental disconnections or misconnections, and costs. Avoid the use of stopcocks due to the increased risk of infection. If you choose to use a stopcock, please take extra care to maintain an aseptic environment on all ports during the procedure.

07:34 To instill Cathflo using negative pressure with 1 syringe, first draw up to 2 milliliters of Cathflo using a 10-milliliter syringe, or a syringe specifically designed to generate lower injection pressure. Cathflo should be instilled into the dysfunctional catheter at a concentration of 2 milligrams per 2 milliliters.

07:56 Next, scrub the hub. Apply vigorous friction to the catheter hub for 10 to 15 seconds, then allow the hub to dry. Make sure to prevent it from touching anything while drying. After using aseptic technique to cleanse the catheter hubs, attach the Cathflo filled syringe. To instill Cathflo, create negative pressure, by pulling back on the plunger to the 8 or 9 milliliter mark, and holding it for a few seconds. Gently allow the syringe plunger to return to the neutral position. This will allow Cathflo to mix with the fluid in the catheter and seep to the clot interface deep in the catheter lumen. As with any medication, do not attempt to forcibly push Cathflo into the catheter. Excessive pressure, even with a 10-milliliter syringe or a syringe specifically designed to generate lower injection pressure, could cause catheter rupture if exerted against resistance. Aggressive flushing can also shear off part of the biofilm or thrombus, releasing microorganisms into the bloodstream. Repeat this technique until the full dose of Cathflo is instilled.

09:10 If catheter function is not restored after 2 serial doses of Cathflo, the physician should be notified, and further catheter management strategies should be discussed. There's no efficacy or safety information on dosing in excess of 2 milligrams per dose for this indication. If catheter function is restored at any assessment, aspirate 4 to 5 milliliters of blood in patients greater than or equal to 10 kilograms in weight, or 3 milliliters in patients less than 10 kilograms in weight, to remove Cathflo and residual clot.

09:47 With a new 10-milliliter syringe, or a syringe specifically designed to generate lower injection pressure. Use a pulsatile flush or push pause technique, to irrigate the catheter with 0.9% sodium chloride USP. Any unused solution should be discarded. You may then proceed with administering therapy as planned. If the catheter is still occluded, a second dose of equal amount may be instilled, with an assessment done at 30 and 120 minutes.

10:27 Indication

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

10:40 Important Safety Information; Contraindications  

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

10:52 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. 

11:28 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. 

12:07 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.

12:32 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.

12:51 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. 

13:15 Carcinogenesis, Mutagenesis, Impairment of Fertility

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

13:27 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.

13:41 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 Cathflo full prescribing information for important safety information. For more information about Cathflo, visit Cathflo.com.

INS=Infusion Nurses Society.

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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