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Home > Activase for Acute Ischemic Stroke > Activase Dosing and Administration

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Activase Dosing and Administration

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 bolus over 1 minute.2

FDA recommendations on prescribing Activase

In October 2015, the FDA issued recommendations to address reported medication errors attributed to confusion between Activase and TNKase® (tenecteplase), a different tissue plasminogen activator.39

The FDA recommends using either the brand name, Activase, or the generic name, alteplase, on written prescriptions and verbal orders.39

Reconstitution of 100-mg Vials2

Reconstitution of 100-mg Vials

100-mg Vials Video

Begin by assembling the Activase vial; the vial of Sterile Water for Injection (SWFI), USP; 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 by adding the contents of the 100-mL vial of SWFI to the 100-mg vial of Activase powder. Reconstitute Activase immediately before administration, using aseptic technique at all times.

  • 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. DO NOT INVERT THE VIAL OF SWFI. 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 (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. Approximately 0.5 mL of SWFI will remain in the diluent 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. This preparation will result in a colorless to pale yellow transparent solution containing Activase at a concentration of 1 mg/mL. Visually inspect the Activase solution for particulate matter and discoloration before administration

The solution may be used for intravenous administration within 8 hours following reconstitution when stored between 2-30°C (36-86°F). Do not add other medication to solutions containing Activase. Any unused infusion solution should be discarded.

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.


Activase® (alteplase) is indicated for the treatment of acute ischemic stroke (AIS). 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


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; 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


Activase can cause internal or external bleeding, especially at arterial and venous puncture sites. Avoid intramuscular injections and trauma to the patient. Fatal cases of hemorrhage associated with traumatic intubation in patients administered Activase have been reported. The concomitant administration of heparin and aspirin with and following infusions of Activase 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.

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; high likelihood of left heart thrombus; 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.

Orolingual Angioedema

Orolingual angioedema has been observed during and up to 2 hours after infusion. In many cases, patients received concomitant angiotensin-converting enzyme inhibitors. Monitor patients treated with Activase during and for several hours after Activase infusion for orolingual angioedema. If angioedema develops, discontinue the Activase infusion and promptly institute appropriate therapy.

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 and/or anticoagulant therapy.

Reembolization of Deep Venous Thrombi during Treatment for Acute Massive Pulmonary Embolism

Activase has not been shown to treat adequately underlying deep vein thrombosis in patients with PE. Consider the possible risk of reembolization due to the lysis of underlying deep venous thrombi in this setting.

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.

Adverse Reactions

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

Although exploratory analyses of the AIS clinical studies suggest that severe neurological deficit (National Institutes of Health Stroke Scale [NIHSS > 22]) at presentation was associated with an increased risk of intracranial hemorrhage, efficacy results suggest a reduced but still favorable clinical outcome for these patients.

Allergic-type reactions, e.g., anaphylactoid reaction, laryngeal edema, orolingual angioedema, rash, and urticaria have been reported.


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