Dosing and administration for acute ischemic stroke
How is Activase dosed for acute ischemic stroke?
The FDA-approved dose of Activase is 0.9 mg/kg, and the total dose should not exceed 90 mg. Treatment should be initiated with 10% of the total dose administered as a bolus injection over 1 minute and the remaining dose infused over 60 minutes.
Reconstitution of 100-mg vials
Begin by assembling the Activase vial, the vial of SWFI, and the transfer device included in the Activase package. Also, gather alcohol swabs and 2 syringes: 1 for the bolus dose and 1 for the discarded quantity of Activase.
Reconstitution should be carried out using the transfer device provided and adding the contents of the 100-mL vial of SWFI to the 100-mg vial of Activase powder.
Step 1:
Remove the protective cap from the top of the Activase vial and the vial of SWFI. Swab the top of each vial with an alcohol wipe to reduce the risk of contamination.
Step 2:
Remove the transfer device from its wrapper and remove the protective cap from one end. Insert the piercing pin vertically into the center of the stopper of the vial of SWFI, keeping the vial upright.
Step 3:
Remove the protective cap from the other end of the transfer device. Holding the vial of Activase upside down, position it so that the center of the stopper is directly over the exposed pin of the transfer device.
Step 4:
Push the vial of Activase down onto the transfer device, making sure that the piercing pin is inserted through the center of the Activase vial stopper.
Step 5:
Invert the 2 vials, so that the vial of Activase is on the bottom, right side up, and the vial of SWFI is on top. Allow the entire contents of the vial of SWFI to flow down through the transfer device into the vial containing Activase—a process that requires approximately 2 minutes. About half a milliliter of Sterile Water may remain in the upper vial.
Step 6:
Remove the transfer device and the empty SWFI vial from the Activase vial. Safely discard both the transfer device and the empty diluent vial according to institutional procedures.
Step 7:
Mix the solution with a gentle swirl or slow inversion. DO NOT SHAKE. Slight foaming of the solution is normal. Let the solution stand undisturbed for several minutes to allow any large bubbles to dissipate. Visually inspect the Activase solution for particulate matter and discoloration before administration.
Activase is stable for up to 8 hours in these solutions at room temperature. Do not freeze solutions containing Activase. No other medications should be added to infusions containing Activase. Any unused infusion solution should be discarded.
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Reconstitution of 50-mg vials
A single 50-mg vial of Activase may be used to treat patients weighing up to 122 lbs or 55.5 kilograms. Reconstitute Activase immediately before administration, using aseptic technique at all times—including thorough hand washing and the use of gloves.
Step 1:
Assemble the 50-mg vial of Activase, the vial of Sterile Water for Injection (SWFI), USP (included with the Activase package), a 50-mL syringe, a large-bore needle (eg, 18-gauge), and alcohol wipes. Also, prepare a polyvinyl chloride bag or glass vial along with an infusion set.
Step 2:
Remove the protective cap from the top of the Activase vial and the vial of SWFI. Swab the top of each vial with an alcohol wipe to reduce the risk of contamination.
Step 3:
Withdraw 50 mL of SWFI, without preservatives. Diluent is included. DO NOT USE Bacteriostatic Water for Injection, USP.
Step 4:
Inject the 50 mL into the 50-mg Activase vial using a large-bore needle and syringe, directing the stream into the lyophilized cake. DO NOT USE IF VACUUM IS NOT PRESENT. The syringe should not be primed with air during preparation and should be inserted into the Activase vial stopper. Slight foaming upon reconstitution is normal. Let the solution stand undisturbed for several minutes to allow any large bubbles to dissipate.
Step 5:
Mix with a gentle swirl or slow inversion. DO NOT SHAKE. Visually inspect the Activase solution for particulate matter and discoloration before administration.
Activase is stable for up to 8 hours in these solutions at room temperature. Do not freeze solutions containing Activase. No other medications should be added to infusions containing Activase. Any unused infusion solution should be discarded.
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Administration of bolus
Step 1:
Discard excess
To ensure proper dosing, discard excess by removing from vial any quantity of drug in excess of that specified for patient treatment. When drawing off excess solution, be sure to insert the needle into the peripheral area of the vial top, away from the puncture site caused by the transfer device.
Step 2:
Prepare Bolus
Withdraw 10% of the 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, or
– Program infusion pump to deliver bolus at infusion initiation. Remember to prime the
intravenous (IV) pump with the Activase solution so that the remainder of the infusion begins
immediately following the bolus dose
Step 3:
Administer Bolus
Administer initial IV bolus over 1 minute.
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Administration of remainder of dose
Infuse the remaining 90% of 0.9-mg/kg dose over 60 minutes.
100-mg vials — 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 can also be administered by programming an infusion pump. Remember to prime the IV pump tubing with the Activase solution so that the infusion begins immediately following the bolus dose.
Because IV pumps and tubing vary, a standardized procedure should be initiated at each hospital to ensure delivery of the full Activase dose, including the volume of Activase in the IV tubing. One possible solution is to spike a small bag (eg, 50 mL) of 0.9% Sodium Chloride Injection, USP, with the end of the Activase infusion set when the Activase vial is empty. The Infusion should continue at the same rate to ensure that all the Activase remaining in the tubing is received by the patient.
No medication should be added to the infusion solutions that contain Activase.
50-mg vials — Administer using either a polyvinyl chloride bag or glass vial and infusion set.
Please see full prescribing information.
View the Activase (t-PA) Dosing and Administration video.
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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).
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.
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