CATHFLO 2 MG — DIN 02245859

What is CATHFLO?

CATHFLO 2 MG contains ALTEPLASE : 2 MG. It is listed in the Health Canada Drug Product Database under DIN 02245859, held by HOFFMANN-LA ROCHE LIMITED, supplied as POWDER FOR SOLUTION for INSTILLATION administration. Health Canada currently lists it as marketed, status dated 26-Sep-2002. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is CATHFLO used for?

Cathflo® (alteplase, recombinant) is indicated for the restoration of function to central venous access devices.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

Cathflo® (alteplase, recombinant) is for intracatheter administration (instillation into the dysfunctional catheter). Recommended Dose and Dosage Adjustment: For patients weighing 30 kg and over, the dose of Cathflo® is 2 mg, with a dose volume of 2 mL. The recommended dose for patients weighing less than 30 kg is 110% of the internal lumen volume of their CVAD, not to exceed 2 mL. There is no efficacy and safety information on dosing in excess of 2 mg per dose. Studies have not been performed with total doses greater than 4 mg (two 2-mg doses). Preparation of Solution: 1. Reconstitute Cathflo® to a final concentration of 1 mg/mL. 2. Aseptically withdraw 2.2 mL of Sterile Water for Injection, USP (diluent is not provided). Do not use Bacteriostatic Water for Injection, USP, for reconstitution as it has not been studied clinically. 3. Inject the 2.2 mL 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. Mix by gently swirling until the contents are completely dissolved. DO NOT SHAKE. The reconstituted preparation results in a colourless to pale yellow transparent solution containing 1 mg/mL Cathflo® at a pH of approximately 7.3. 5. Cathflo® contains no antibacterial preservatives and should be reconstituted immediately before use. The solution may be used within 8 hours following reconstitution when stored at 2°C-30°C. 6. Withdraw 2.0 mL (2.0 mg) of solution from the reconstituted vial. No other medication should be added to solutions containing Cathflo®. Administration: 1. Inspect the product prior to administration for foreign matter and discolouration. 2. Instill the appropriate dose of Cathflo® (see Usual Dose) into the occluded catheter. 3. After 30 minutes of dwell time, assess catheter function by attempting to aspirate blood. If the catheter is functional, go to Step 6. If the catheter is not functional, go to Step 4. 4. After 120 minutes of dwell time, assess catheter function by attempting to aspirate blood and catheter contents. If the catheter is functional, go to Step 6. If the catheter is not functional, go to Step 5. 5. If catheter function is not restored after one dose of Cathflo®, a second dose may be instilled. Repeat the procedure beginning with Step 2. 6. If catheter function has been restored, aspirate 4-5 mL of blood to remove Cathflo® and residual clot, discard aspirate and gently irrigate the catheter with 0.9% Sodium Chloride, USP.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

Patients who are hypersensitive to Cathflo® (alteplase, recombinant), to any ingredient in the formulation (i.e. L-arginine, phosphoric acid and polysorbate 80) or component of the container.

Warnings and precautions

Catheter dysfunction may be caused by a variety of conditions other than thrombus formation, such as catheter malposition, mechanical failure, constriction caused by a suture, and lipid deposits or drug precipitates within the lumen of the catheter. During attempts to determine catheter occlusion, vigorous suction should not be applied because of the risk of damage to the vascular wall or collapse of soft-walled catheters. Excessive pressure should be avoided when any medication including Cathflo™ (alteplase, recombinant) 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. Known conditions have been associated with an increased risk of bleeding with the use of thrombolytics. Patients with known conditions associated with bleeding events were excluded from the pivotal trials; thus Cathflo® has not been studied in this patient population. Caution should be exercised with patients who have active internal bleeding or who have had any of the following within 48 hours: coronary artery bypass graft surgery, obstetrical delivery, organ biopsy, or puncture of non-compressible vessels. In addition, caution should be exercised with patients who have hemostatic defects (including those secondary to severe hepatic or renal disease) or any condition in which bleeding constitutes a significant hazard or would be particularly difficult to manage because of its location, or who are at high risk for embolic complications (e.g., recent pulmonary embolism, deep vein thrombosis, endarterectomy). Death and permanent disability have been reported in patients who have experienced stroke and other serious bleeding episodes when receiving pharmacologic doses of a thrombolytic. Should serious bleeding in a critical location (e.g., intracranial, gastrointestinal, retroperitoneal, pericardial) occur, treatment with Cathflo® should be stopped and the drug should be withdrawn from the catheter. When treating infected catheters, risks for systemic infection include surgical replacement of the catheter and successful thrombolysis; both may release localized infection into systemic circulation. In the pivotal safety trial, four patients developed sepsis from 16 minutes to 3 days following alteplase treatment. All four patients responded to antibiotic therapy (see PHARMACOLOGY: Safety Trial). Cathflo® should be used with caution in the presence of known or suspected infection in the catheter. As with all catheterization procedures, care should be used to maintain aseptic technique. Hypersensitivity: Hypersensitivity might occur during treatment of occluded catheters in cases where Cathflo reaches the systemic circulation. In the event that an anaphylactoid reaction were to occur upon the administration of Cathflo®, appropriate therapy should be initiated.