Activase

2 DOSAGE AND ADMINISTRATION Acute Ischemic Stroke : The recommended dose is 0.9 mg/kg (not to exceed 90 mg total dose) infused intravenously over 60 minutes with 10% of the total dose administered as an initial bolus over 1 minute. ( 2.1 ) Acute Myocardial Infarction : The recommended total dose is based on patient weight, not to exceed 100 mg. ( 2.2 ) Acute Massive Pulmonary Embolism : The recommended dose is 100 mg administered by IV infusion over 2 hours. ( 2.3 ) Do not add other medications to infusions containing Activase. ( 2.5 ) 2.1 Acute Ischemic Stroke Administer Activase as soon as possible but within 3 hours after onset of symptoms. The recommended dose is 0.9 mg/kg (not to exceed 90 mg total dose), with 10% of the total dose administered as an initial intravenous bolus over 1 minute and the remainder infused over 60 minutes. During and following Activase administration for the treatment of acute ischemic stroke, frequently monitor and control blood pressure. In patients without recent use of oral anticoagulants or heparin, Activase treatment can be initiated prior to the availability of coagulation study results. Discontinue Activase if the pretreatment International Normalized Ratio (INR) is greater than 1.7 or the activated partial thromboplastin time (aPTT) is elevated [see Contraindications (4.1) ] . 2.2 Acute Myocardial Infarction Administer Activase as soon as possible after the onset of symptoms. The recommended total doses for acute myocardial infarction (AMI) is based on patient weight, not to exceed 100 mg, regardless of the selected administration regimen (accelerated or 3 hour, described below). There are two Activase dose regimens (accelerated and 3-hour) for use in the management of AMI; there are no controlled studies to compare clinical outcomes with these regimens [see Clinical Studies (14.2) ]. Accelerated Infusion The recommended accelerated infusion dose consists of an IV bolus [see Dosage and Administration (2.4 , 2.5) ] followed by an IV infusion as set forth in Table 1 . Table 1 Accelerated Infusion Weight-Based Doses for Patients with AMI Patient weight Intravenous Bolus First 30 min Next 60 min > 67 kg 15 mg 50 mg 35 mg ≤ 67 kg 15 mg 0.75 mg/kg 0.50 mg/kg The safety and efficacy of accelerated infusion of Activase have only been investigated with concomitant administration of heparin and aspirin [see Clinical Studies (14.2) ] . 3-Hour Infusion For patients weighing ≥ 65 kg, the recommended dose is 100 mg administered as 60 mg in the first hour (6-10 mg administered as a bolus), 20 mg over the second hour, and 20 mg over the third hour. For smaller patients (< 65 kg), a dose of 1.25 mg/kg administered over 3 hours may be used. Weight-based doses are shown in Table 2 . Table 2 3-hour Infusion Weight-Based Doses for Patients with AMI Patient weight Bolus Rest of 1st hour 2nd hour 3rd hour ≥ 65 kg 6-10 mg 50-54 mg 20 mg 20 mg < 65 kg 0.075 mg/kg 0.675 mg/kg 0.25 mg/kg 0.25 mg/kg 2.3 Pulmonary Embolism (PE) The recommended dose is 100 mg administered by IV infusion over 2 hours. Institute parenteral anticoagulation near the end of or immediately following the Activase infusion when the partial thromboplastin time or thrombin time returns to twice normal or less. 2.4 Activase 50 mg Reconstitution and Administration Instructions Activase is for intravenous administration only. Do not add any other medication to infusion solutions containing Activase. Extravasation of Activase infusion can cause ecchymosis or inflammation. If extravasation occurs, terminate the infusion at that intravenous site and apply local therapy. Use within 8 hours following reconstitution (when stored at 2–30°C). Activase contains no antibacterial preservatives. Activase 50 mg Reconstitution Notes Use only the accompanying Sterile Water for Injection (SWFI), USP without preservatives. Do not use Bacteriostatic Water for Injection, USP. Reconstitute using aseptic technique. Slight foaming is not unusual; let stand undisturbed for several minutes to allow large bubbles to dissipate. Inspect parenteral drug products for particulate matter and discoloration prior to administration whenever solution and container permit. Activase may be administered as reconstituted at 1 mg/mL or further diluted immediately before administration in an equal volume of 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP, to yield a concentration of 0.5 mg/mL, using either polyvinyl chloride bags or glass vials. Avoid excessive agitation during dilution; mix by gently swirling and/or slow inversion. Activase 50 mg Reconstitution Instructions DO NOT USE IF VACUUM IS NOT PRESENT. Using a large bore needle (e.g., 18 gauge) and a syringe, reconstitute by adding the contents of the accompanying 50 mL vial of SWFI to the 50 mg vial of Activase, directing the SWFI stream into the lyophilized cake. Activase 50 mg Preparation of Bolus Dose Prepare the bolus dose in one of the following ways: Remove the appropriate volume from the vial of reconstituted (1 mg/mL) Activase using a syringe and needle. The syringe should not be primed with air and the needle should be inserted into the Activase vial stopper. Remove the appropriate volume from a port (second injection site) on the infusion line after the infusion set is primed. Program an infusion pump to deliver the appropriate volume as a bolus at the initiation of the infusion. Activase 50 mg Administration Following bolus dose, if indicated [see Dosage and Administration (2.1 , 2.2) ]: Administer using either a polyvinyl chloride bag or glass vial and infusion set. 2.5 Activase 100 mg Instructions for Use See the enclosed Instructions for Use for Activase 100 mg enclosed in the carton for reconstitution and administration instructions. Alternative Dilution Instructions Activase may be administered as reconstituted at 1 mg/mL or further diluted immediately before administration in an equal volume of 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP, to yield a concentration of 0.5 mg/mL, using either polyvinyl chloride bags or glass vials.

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1 INDICATIONS AND USAGE Activase is a tissue plasminogen activator (tPA) indicated for the treatment of: Acute Ischemic Stroke (AIS).