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Reconstitute Activase® immediately before administration

The recommended treatment dose of Activase is 0.9 mg/kg (not to exceed 90 mg total treatment dose) infused over 60 minutes with 10% of the total treatment dose administered as an initial bolus over 1 minute.6

Activase® (alteplase) 100mg Product Shot

Follow the steps below for reconstituting 100-mg vials.6

  • Reconstitute Activase immediately before administration, using only preservative free Sterile Water for Injection (SWFI), U.S. Pharmacopeia (USP) and the transfer device. Do not use Bacteriostatic Water for Injection, USP.
  • Begin by assembling the Activase vial; the vial of SWFI, USP; and the transfer device included in the Activase package. Also gather alcohol swabs and 2 syringes—1 for the bolus treatment dose and 1 for the discarded quantity of Activase.
Activase® (alteplase) 100mg kit
  • Reconstitution should be carried out using the transfer device provided and by adding the contents of the 100‑mL vial of preservative free SWFI to the 100-mg vial of Activase powder. Reconstitute Activase immediately before administration, using aseptic technique at all times.

Step 1:

Remove protective caps and swab the top of each vial with a separate alcohol wipe to reduce the risk of contamination.

REMOVE CAPS

Activase® (alteplase) 100mg cap removal

CLEANING

Activase® (alteplase) sterilize

Step 2:

Remove one of the protective caps from the transfer device and insert the piercing pin vertically into the center of the stopper of the SWFI vial, keeping the vial upright. Do not invert water vial yet. Inverting too early may lead to leakage and incorrect dosing. Remove the other protective cover from the transfer device. Do not wipe transfer device spikes with alcohol. Holding the Activase vial upside down, position it so that the center of the stopper is directly over the exposed pin of the transfer device. Push vial down onto the transfer device, ensuring that the piercing pin is inserted through the center of the Activase vial stopper. Inserting the spike off-center could lead to stopper collapse.

INSERT TRANSFER PIN IN SWFI VIAL

Activase® (alteplase) 100mg Vial SWIFa

INSERT ACTIVASE VIAL ON OTHER END OF PIN

Activase® (alteplase) 100mg Vial End Of Pin

PUSH DOWN

Activase® (alteplase) 100mg Vial Push Down

Step 3:

Invert the 2 vials, so that the vial of Activase is on the bottom (upright) and the vial of SWFI is upside down. Allow the entire contents of the vial of SWFI to flow down through the transfer device into the vial containing Activase. If flow does not start immediately or pauses, initiate flow by flipping and re-inverting the vials.

INVERT VIALS

Activase® (alteplase) 100mg Vial Invert

Step 4:

Mix the solution with a gentle swirl. Do not shake vials. Shaking may lead to excessive foaming and degraded medication. Slight foaming of the solution is normal. Let the solution stand undisturbed for several minutes to allow any large bubbles to dissipate. 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.

MIX GENTLY

Activase® (alteplase) 100mg vial mix

DISCARD PIN AND SWFI VIAL

Activase® (alteplase) 100mg Discard

Step 5:

  • Reconstituted Activase vial (1 mg/mL) should be:
    • Colorless to pale yellow and transparent
    • Free of particulates
  • If needed, let stand undisturbed for a few minutes to allow large bubbles to dissipate.
Activase® (alteplase) 100mg Inspect

Please see the full Prescribing Information for additional Important Safety Information and Instructions for Use.

NEXT: Learn how to dose and administer 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
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Activase® (alteplase) 100mg

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Activase® (alteplase) 50mg

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IMPORTANT SAFETY INFORMATION & INDICATIONS

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 the full Prescribing Information for additional Important Safety Information and Instructions for Use.

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