following completion of treatment.
No pediatric patients in Trial 3 experienced an intracranial hemorrhage, major hemorrhage, thrombosis, or an embolic event.
Three cases of sepsis occurred 2 to 44 hours after treatment with Cathflo Activase. All of these patients had evidence of infection prior to administration of Cathflo Activase. An additional patient developed fever and lethargy within one day of Cathflo Activase administration, which required outpatient intravenous antibiotics. In one subject, the lumen of the catheter, placed 2 years previously, ruptured with infusion of the study drug.
There were no gender-related differences observed in the rates of adverse reactions. Adverse reactions profiles were similar across all age groups.
Allergic Reactions
No allergic-type reactions were observed in the trials in patients treated with Alteplase. If an anaphylactic reaction occurs, appropriate therapy should be administered.
DOSAGE AND ADMINISTRATION
Cathflo® Activase® (Alteplase) is for instillation into the dysfunctional catheter at a concentration of 1 mg/mL.
• Patients weighing ≥30 kg: 2 mg in 2 mL
• Patients weighing <30 kg:110% of the internal lumen volume of the catheter, not to exceed 2 mg in 2 mL
If catheter function is not restored at 120 minutes after 1 dose of Cathflo Activase, a second dose may be instilled (see Instructions for Administration). There is no efficacy or safety information on dosing in excess of 2 mg per dose for this indication. Studies have not been performed with administration of total doses greater than 4 mg (two 2‑mg doses).
Instructions for Administration
Preparation of Solution
Reconstitute Cathflo Activase to a final concentration of 1 mg/mL:
1.Aseptically withdraw 2.2 mL of Sterile Water for Injection, USP (diluent is not provided). Do not use Bacteriostatic Water for Injection.
2.Inject the 2.2 mL of Sterile Water for Injection, USP, into the Cathflo Activase vial, directing the diluent stream into the powder. Slight foaming is not unusual; let the vial stand undisturbed to allow large bubbles to dissipate.
3.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 containing 1 mg/mL Cathflo Activase at a pH of approximately 7.3.
4.Cathflo Activase contains no antibacterial preservatives and should be reconstituted immediately before use. The solution may be used for intracatheter instillation within 8 hours following reconstitution when stored at 2–30°C (36–86°F).
No other medication should be added to solutions containing Cathflo Activase.
Instillation of Solution into the Catheter
1.Inspect the product prior to administration for foreign matter and discoloration.
2.Withdraw 2 mL (2 mg) of solution from the reconstituted vial.
3.Instill the appropriate dose of Cathflo Activase (see DOSAGE AND ADMINISTRATION) into the occluded catheter.
4.After 30 minutes of dwell time, assess catheter function by attempting to aspirate blood. If the catheter is functional, go to Step 7. If the catheter is not functional, go to Step 5.
5.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 7. If the catheter is not functional, go to Step 6.
6.If catheter function is not res |
