Activase

Activase Manufacturers

• Genentech, Inc.
  

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  Activase | Genentech, Inc.

  

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  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 (2.5)] 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 Preparation for Administration

  Reconstitution

  Use only the accompanying Sterile Water for Injection (SWFI), USP without preservatives. Do not use Bacteriostatic Water for Injection, USP.

  Reconstitute using aseptic technique. Do not add other medication to solutions containing Activase. Reconstitute Activase no more than 8 hours before use, as it contains no antibacterial preservatives [see How Supplied/Storage and Handling (16.2)].

  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.

  50 mg Vials

    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.

  100 mg Vials

    THE 100 mg VIALS DO NOT CONTAIN VACUUM.   Using the transfer device provided, reconstitute by adding the contents of the accompanying 100 mL vial of SWFI to the 100 mg vial of Activase. Use aseptic technique. Remove the protective flip-caps from one vial of Activase and one vial of SWFI. Open the package containing the transfer device by peeling the paper label off the package. Remove the protective cap from one end of the transfer device and keeping the vial of SWFI upright, insert the piercing pin vertically into the center of the stopper of the vial of SWFI. Remove the protective cap from the other end of the transfer device. DO NOT INVERT THE VIAL OF SWFI. Hold the vial of Activase upside down, position it so that the center of the stopper is directly over the exposed piercing pin of the transfer device, and push the vial of Activase down so that the piercing pin is inserted through the center of the Activase vial stopper. Invert the two vials so that the vial of Activase is on the bottom (upright) and the vial of SWFI is upside-down, allowing the SWFI to flow down through the transfer device. Allow the entire contents of the vial of SWFI to flow into the Activase vial (approximately 0.5 cc of SWFI will remain in the diluent vial). Remove the transfer device and the empty SWFI vial from the Activase vial and discard. Swirl gently to dissolve the Activase powder. DO NOT SHAKE.

  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. If this method is used with the 50 mg vials, the syringe should not be primed with air and the needle should be inserted into the Activase vial stopper. If the 100 mg vial is used, the needle should be inserted away from the puncture mark made by the transfer device. 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 2.5 Administration

  Following bolus dose, if indicated [see Dosage and Administration (2.1, 2.2)]:

  50 mg vials - administer using either a polyvinyl chloride bag or glass vial and infusion set. 100 mg vials - remove from the vial any quantity of drug in excess of that specified for patient treatment [see Dosage and Administration (2.1, 2.2)]. Insert the spike end of an infusion set through the same puncture site created by the transfer device in the stopper of the vial of reconstituted Activase. Peel the clear plastic hanger from the vial label. Hang the Activase vial from the resulting loop.

  Activase is for intravenous administration only. Extravasation of Activase infusion can cause ecchymosis or inflammation. If extravasation occurs, terminate the infusion at that IV site and apply local therapy.

  Do not add any other medication to infusion solutions containing Activase.

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