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Dosing and administration for acute ischemic stroke

The recommended dose of Activase (Alteplase) is 0.9 mg/kg (not to exceed 90 mg total dose) infused over 60 minutes, with 10% of the total dose administered as an initial intravenous bolus over 1 minute.

Reconstitution of 100-mg vials

  • Use aseptic technique throughout
  • Remove the protective flip-caps from 1 vial of Activase (t-PA) and 1 vial of Sterile Water for Injection, USP (SWFI)
  • Open the package containing the transfer device by peeling the paper label off the package
  • Remove the protective cap from 1 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
  • Holding the vial of Activase (t-PA) upside down, position it so that the center of the stopper is directly over the exposed piercing pin of the transfer device
  • Push the vial of Activase (t-PA) down so that the piercing pin is inserted through the center of the Activase (t-PA) vial stopper
  • Invert the 2 vials so that the vial of Activase (t-PA) is on the bottom (upright) and the vial of SWFI is upside down, allowing the SWFI to flow down. Allow the entire contents of the vial of SWFI to flow into the Activase (t-PA) vial (approximately 0.5 mL of SWFI will remain in the diluent vial)
  • Remove the transfer device and the empty SWFI vial from the Activase (t-PA) vial. Safely discard both the transfer device and the empty diluent vial according to institutional procedures
  • Swirl gently to dissolve the Activase (t-PA) powder. DO NOT SHAKE

No other medication should be added to infusion solutions containing Activase (t-PA). Any unused infusion solution should be discarded.

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Reconstitution of 50-mg vials

  • Reconstitution should be carried out using a large-bore needle (eg, 18 gauge) and syringe, directing the stream of Sterile Water for Injection, USP into the lyophilized cake. DO NOT USE IF VACUUM IS NOT PRESENT
  • Slight foaming upon reconstitution is not unusual; standing undisturbed for several minutes is usually sufficient for dissipation of large bubbles
  • The remainder of the 50-mg dose may be administered using a polyvinyl chloride bag or glass vial and infusion set
  • No medication should be added to infusion solutions that contain Activase (t-PA). For specifics regarding dosing and administration, please see the Activase (t-PA) full prescribing information

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Administration of bolus

  • Step 1: Inspect solution
    After reconstitution to 1 mg/mL, inspect solution for particulate matter and discoloration prior to administration.
  • Step 2: Discard excess
    To ensure proper dosing, remove from vial any quantity of drug in excess of that specified for patient treatment.
  • Step 3: Prepare bolus
    The syringe should not be primed with air during preparation and should be inserted into the Activase (t-PA) vial stopper. If the 100-mg vial is used, the needle should be inserted away from the puncture mark made by the transfer device.

    Withdraw 10% of 0.9-mg/kg dose in one of the following ways:
    • – Remove from vial using a syringe and needle
    • – Remove from port (second injection site) on infusion line after infusion set is primed
    • – Program infusion pump to deliver bolus at infusion initiation
  • Step 4: Administer bolus
    Administer initial intravenous bolus over 1 minute.

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Administration of remainder of dose

  • Step 5: Administer remainder
    Infuse the remaining 90% of 0.9-mg/kg dose over 60 minutes.
    • – Administer 50-mg vial using a polyvinyl chloride bag or glass infusion set
    • – Administer 100-mg vial by inserting spike end of infusion set through the same puncture site created by the transfer device in stopper of vial and hang from plastic molded capping on vial bottom

Please see full prescribing information.

View the Activase (t-PA) Dosing and Administration video.

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Activase (t-PA)

Indication
Activase (Alteplase) is indicated for the management of acute ischemic stroke in adults for improving neurological recovery and reducing the incidence of disability. Treatment should only be initiated within 3 hours after the onset of stroke symptoms, and after exclusion of intracranial hemorrhage by a cranial computerized tomography (CT) scan or other diagnostic imaging method sensitive for the presence of hemorrhage (see CONTRAINDICATIONS).

Safety Information
Activase therapy in patients with AIS is contraindicated in certain situations (eg, suspicion of subarachnoid hemorrhage on pretreatment evaluation, recent (within 3 months) intracranial or intraspinal surgery, history of intracranial hemorrhage, uncontrolled hypertension at time of treatment, active internal bleeding, known bleeding diathesis (eg, current use of oral anticoagulants, administration of heparin within 48 hours of onset of stroke, platelet count <100,000) (see CONTRAINDICATIONS for full list).

The most common complication during Activase therapy is bleeding. Should serious bleeding in a critical location (intracranial, gastrointestinal, retroperitoneal, pericardial) occur, Activase therapy should be discontinued immediately. Death and permanent disability are not uncommonly reported in patients who have experienced stroke (including intracranial bleeding) and other serious bleeding episodes.

The risks of Activase therapy may be increased and should be weighed against the anticipated benefits in certain conditions. [See WARNINGS in full prescribing information].

  • Patients with severe neurological deficit (eg, NIHSS >22) at presentation. There is an increased risk of intracranial hemorrhage in these patients.
  • Patients with major early infarct signs on a computerized cranial tomography (CT) scan (eg, substantial edema, mass effect, or midline shift).

Treatment of patients with minor neurological deficit or with rapidly improving symptoms is not recommended.

Orolingual angioedema has been observed in postmarketing experience in patients treated with Activase for AIS. Patients should be monitored during and for several hours after infusion for signs of orolingual angioedema.

Please click here for full prescribing information.