Alteplase - (ACTIVASE, TPA)

Usual Diluents

Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate]

Stability / Miscellaneous

Dosing:
Acute MI: (2 protocols)- (1) (Preferred) Accelerated infusion: for patients > 65kg: 15 mg IV bolus f/b 50mg over next 30min, and the remaining 35mg (100mg total) infused over the next 60 min. Patients <65kg: 15 mg bolus, then 0.75 mg/kg (max 50 mg) over 30 minutes, then 0.5 mg/kg (max 35 mg) over next 60 minutes. (2) 3-hour infusion (may be less effective): In 1st hour, 60 mg is administered (of which 6-10mg is administered ivpush in first 1-2 minutes), followed by 20 mg/hr x 2 hours. (100mg total). For patients <65 kg: administer 1.25 mg/kg in the same manner over 3 hours.

Pulmonary embolism: 100 mg over 2 hours.
Stroke: (Give within first 3 hours): 0.9 mg/kg (max 90mg)-10% of dose given ivpush, followed by a continuous infusion over 1 hour.

Intracatheter: Cathflo® Activase® (Alteplase) is for instillation into the dysfunctional catheter at a concentration of 1 mg/mL.

DOSAGE AND ADMINISTRATION
• 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). Package insert.

Instructions for Administration
Preparation of Solution: Reconstitute Cathflo Activase to a final concentration of 1 mg/mL: Aseptically withdraw 2.2 mL of Sterile Water for Injection, USP (diluent is not provided). Do not use Bacteriostatic Water for Injection. 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. 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. 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 Inspect the product prior to administration for foreign matter and discoloration. Withdraw 2 mL (2 mg) of solution from the reconstituted vial. Instill the appropriate dose of Cathflo Activase (see DOSAGE AND ADMINISTRATION) into the occluded catheter. 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. 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. If catheter function is not restored after one dose of Cathflo Activase, a second dose of equal amount may be instilled. Repeat the procedure beginning with Step 1 under Preparation of Solution. If catheter function has been restored, aspirate 4-5 mL of blood in patients >/=10 kg or 3 mL in patients <10 kg to remove Cathflo Activase and residual clot, and gently irrigate the catheter with 0.9% Sodium Chloride Injection, USP. Any unused solution should be discarded.

Stability and Storage Store lyophilized Cathflo Activase at refrigerated temperature (2-8°C/36-46°F). Do not use beyond the expiration date on the vial. Protect the lyophilized material during extended storage from excessive exposure to light.

HOW SUPPLIED Cathflo Activase (Alteplase) for injection is supplied as a sterile, lyophilized powder in 2 mg vials. Each Cathflo®Activase® carton contains one 2 mg vial of Cathflo® Activase® (Alteplase): NDC 50242-041-64.

Intra-arterial: Acute peripheral arterial occlusive disease (unlabeled use): 0.02-0.1 mg/kg/hour for up to 36 hours Advisory Panel to the Society for Cardiovascular and Interventional Radiology on Thrombolytic Therapy recommendation: </=2 mg/hour and subtherapeutic heparin (aPTT <1.5 times baseline) Additional info