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Monitor patients during and post Activase® administration

The recommended treatment dose of Activase is 0.9 mg/kg (not to exceed 90 mg total treatment dose) infused over 60 minutes.6

  • 10% of the total treatment dose should be administered as an initial bolus over 1 minute
  • The remaining treatment dose should be infused intravenously over 60 minutes
Administering Activase: A step-by-step guide
Step 1:

Inspect the solution for particulate matter and discoloration prior to administration.

INSPECT SOLUTION
Activase® (alteplase) 100mg Inspect
Step 2:

To ensure proper dosing, discard excess by removing any quantity of drug in excess of that specified for the patient's treatment. Be sure to insert the needle into the keyhole port of the vial top, away from the puncture site made by the transfer device, and do not prime the syringe.

DISCARD EXCESS
Activase® (alteplase) 100mg Discard Excess
Step 3:

The bolus treatment dose is 10% of the 0.9 mg/kg treatment dose. Prepare it one of the following ways, using a syringe and needle:

PREPARE BOLUS
REMOVE FROM Y-SITE
Activase® (alteplase) 100mg Prepare Bolus

Remove the treatment dose from the Y-site injection port on the infusion line after the infusion set is primed.

OR REMOVE FROM VIAL
Activase® (alteplase) 100mg Insert Needle

Remove the treatment dose before the vial is attached to the infusion set. Be sure to insert the needle away from the puncture site made by the transfer device.

Do not prime the syringe.

Step 4:
100-mg vials

Insert the spike end of an infusion set through the center of the stopper of the vial of reconstituted Activase, using the same puncture site made by the transfer device.

INSERT SET THROUGH CENTER OF STOPPER
Activase® (alteplase) 100mg Prepare Infusion

Peel the clear plastic hanger from the vial label. Hang the Activase vial from the resulting loop.

PEEL PLASTIC HANGER
Activase® (alteplase) 100mg Peel
HANG ACTIVASE VIAL
Activase® (alteplase) 100mg Hang
50-mg vials

Administer using either a polyvinyl chloride bag or a glass vial and infusion set.

Step 5:

Prime infusion set tubing with Activase solution and administer initial IV bolus over 1 minute.

PRIME INFUSION SET
Activase® (alteplase) 100mg Prime
ADMINISTER BOLUS
Activase® (alteplase) 100mg Administer Bolus
Step 6:

Administer remainder.
Infuse the remaining 90% of the 0.9 mg/kg treatment dose over 60 minutes. The infusion should begin immediately following the bolus treatment dose.
Activase (bolus and the remainder of the treatment dose) can also be administered using an infusion pump. Make sure to prime the pump tubing with Activase solution so that the infusion begins immediately following the bolus treatment dose.

ALTERNATE METHOD USING INFUSION PUMP
Activase® (alteplase) 100mg Infusion Pump
Step 7:

Clear the line.

Immediately following the bolus dose, infuse the remaining 90% of the 0.9 mg/kg dose over 60 minutes.6  To ensure the full dose is delivered, it may be necessary to clear the line, and you should follow your hospital's protocols.  One example may be to spike a small bag (for example, 100 mL of 0.9% sodium chloride USP) at the end of the Activase infusion set when the vial is empty and continue the infusion at the same rate to ensure the full dose is administered within 60 minutes.

SPIKE 0.9% SODIUM CHLORIDE BAG
Activase100mgSpikeBag

2. Program an infusion pump to flush the IV tubing following administration of treatment dose.

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 other medication to solutions containing Activase.

NEXT: Know what to look for when monitoring patients during and after administering Activase >

DID YOU KNOW?

  • The FDA stated that “tPA” is the abbreviation for the drug class that encompasses all tissue plasminogen activators. To avoid confusion and medication errors, it has directed healthcare professionals to use either the brand name, Activase, or the generic name, alteplase, in written prescriptions and verbal orders.12
  • During and following Activase administration for the treatment of acute ischemic stroke (AIS), frequently monitor and control blood pressure.6
Video

Find more information on reconstitution, dosing, and administration of 100-mg Activase.

Indications

Activase® (alteplase) is indicated for the treatment of acute ischemic stroke. Exclude intracranial hemorrhage as the primary cause of stroke signs and symptoms prior to initiation of treatment. Initiate treatment as soon as possible but within 3 hours after symptom onset.

Activase is indicated for use in acute myocardial infarction (AMI) for the reduction of mortality and reduction of the incidence of heart failure.

Limitation of Use: The risk of stroke may outweigh the benefit produced by thrombolytic therapy in patients whose AMI puts them at low risk for death or heart failure.

Activase is indicated for the lysis of acute massive pulmonary embolism (PE), defined as:

  • Acute pulmonary emboli obstructing blood flow to a lobe or multiple lung segments.
  • Acute pulmonary emboli accompanied by unstable hemodynamics, e.g., failure to maintain blood pressure without supportive measures.

Important Safety Information

Contraindications

Do not administer Activase to treat acute ischemic stroke in the following situations in which the risk of bleeding is greater than the potential benefit: current intracranial hemorrhage (ICH); subarachnoid hemorrhage; active internal bleeding; recent (within 3 months) intracranial or intraspinal surgery or serious head trauma; presence of intracranial conditions that may increase the risk of bleeding (e.g., some neoplasms, arteriovenous malformations, or aneurysms); bleeding diathesis; and current severe uncontrolled hypertension.

Do not administer Activase to treat acute myocardial infarction or pulmonary embolism in the following situations in which the risk of bleeding is greater than the potential benefit: active internal bleeding; history of recent stroke; recent (within 3 months) intracranial or intraspinal surgery or serious head trauma; presence of intracranial conditions that may increase the risk of bleeding; bleeding diathesis; and current severe uncontrolled hypertension.

Warnings and Precautions

Bleeding

Activase can cause significant, sometimes fatal internal or external bleeding, especially at arterial and venous puncture sites. Avoid intramuscular injections and trauma to the patient. Perform venipunctures carefully and only as required. Fatal cases of hemorrhage associated with traumatic intubation in patients administered Activase have been reported. Aspirin and heparin have been administered concomitantly with and following infusion with Activase in the management of acute myocardial infarction and pulmonary embolism. The concomitant administration of heparin and aspirin with and following infusions of Activase for the treatment of acute ischemic stroke during the first 24 hours after symptom onset has not been investigated. Because heparin, aspirin, or Activase may cause bleeding complications, carefully monitor for bleeding, especially at arterial puncture sites. Hemorrhage can occur 1 or more days after administration of Activase, while patients are still receiving anticoagulant therapy. If serious bleeding occurs, terminate the Activase infusion, and treat appropriately.

In the following conditions, the risks of bleeding with Activase are increased and should be weighed against the anticipated benefits: recent major surgery or procedure; cerebrovascular disease; recent intracranial hemorrhage; recent gastrointestinal or genitourinary bleeding; recent trauma; hypertension; acute pericarditis; subacute bacterial endocarditis; hemostatic defects including those secondary to severe hepatic or renal disease; significant hepatic dysfunction; pregnancy; diabetic hemorrhagic retinopathy or other hemorrhagic ophthalmic conditions; septic thrombophlebitis or occluded AV cannula at seriously infected site; advanced age; and patients currently receiving oral anticoagulants, or any other condition in which bleeding constitutes a significant hazard or would be particularly difficult to manage because of its location.

Hypersensitivity

Hypersensitivity, including urticarial / anaphylactic reactions, have been reported after administration of Activase. Rare fatal outcome for hypersensitivity was reported. Angioedema has been observed during and up to 2 hours after Activase infusion in patients treated for acute ischemic stroke and acute myocardial infarction. In many cases, patients received concomitant angiotensin-converting enzyme inhibitors. Monitor patients treated with Activase during and for several hours after infusion for hypersensitivity. If signs of hypersensitivity occur, e.g. anaphylactoid reaction or angioedema develops, discontinue the Activase infusion and promptly institute appropriate therapy (e.g., antihistamines, intravenous corticosteroids, epinephrine).

Thromboembolism

The use of thrombolytics can increase the risk of thrombo-embolic events in patients with high likelihood of left heart thrombus, such as patients with mitral stenosis or atrial fibrillation. Activase has not been shown to treat adequately underlying deep vein thrombosis in patients with PE. Consider the possible risk of re-embolization due to the lysis of underlying deep venous thrombi in this setting.

Cholesterol Embolization

Cholesterol embolism, sometimes fatal, has been reported rarely in patients treated with thrombolytic agents; the true incidence is unknown. It is associated with invasive vascular procedures (e.g., cardiac catheterization, angiography, vascular surgery) and/or anticoagulant therapy.

Coagulation Tests May be Unreliable during Activase Therapy

Coagulation tests and/or measures of fibrinolytic activity may be unreliable during Activase therapy unless specific precautions are taken to prevent in vitro artifacts. When present in blood at pharmacologic concentrations, Activase remains active under in vitro conditions, which can result in degradation of fibrinogen in blood samples removed for analysis.

Adverse Reactions

The most frequent adverse reaction associated with Activase therapy is bleeding.

Please see full Prescribing Information for additional Important Safety Information.

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