Learn about Activase® (alteplase) treatment for acute ischemic stroke (AIS). See full safety for more information. Indications Activase (alteplase) is indicated for. Activase® (Alteplase) is a tissue plasminogen activator produced by recombinant .. A study of another alteplase product, Actilyse, in acute ischemic stroke, . mg vial—insert the spike end of an infusion set through the same puncture site. 5 Apr Abstract. Objective: Define the potential impact on outcomes and health care costs in a newly tPA eligible population. Background: Alteplase.

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The first author must also be the corresponding author of the comment. Remove the protective cap from the other end of the transfer device.

The following adverse reactions have been identified during post-approval use of Activase. A prespecified secondary analysis suggested improved 3-month outcome associated with Activase treatment using the following stroke assessment scales: Initiate treatment as soon as possible but within 3 hours after symptom onset.

Preparation Of Bolus Dose Prepare the bolus dose in one of the following ways: Shiue has nothing to disclose.

The New Alteplase (tPA) Package Insert: What Is the Potential Impact? (P2.296)

The results comparing Activase- and placebo-treated patients for the four outcome scales together Generalized Estimating Equations and individually are presented in Table 7. Sands has received research support from Biogen.

Short-term studies, which evaluated tumorigenicity of Activase and effect on tumor metastases in rodents, were negative. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate the carcinogenic potential or the effect on fertility.

Hypersensitivity Hypersensitivity, including urticaria, angioedema and anaphylaxis, has been reported in association with use of Cathflo Activase. Activase is indicated for use in acute myocardial infarction AMI for the reduction of mortality and reduction of the incidence of heart failure.

Pregnancy There are no adequate and well-controlled studies in pregnant women. Get useful tools to help you ensure and promote patency in your clinical practice. Advise patients to contact a health-care professional if they experience symptoms or signs consistent with bleeding e. The information contained in this section of the site is intended for U. Reconstitute using aseptic technique.


There are two Activase dose regimens accelerated and 3-hour for use in the management of AMI; there are no controlled studies to compare clinical outcomes with these regimens [see Clinical Studies ]. 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.

When introduced into the systemic circulation at pharmacologic concentration, alteplase binds to fibrin in a thrombus and converts the entrapped plasminogen to plasmin. Extravasation of Activase infusion can cause ecchymosis or inflammation. In clinical studies in patients with AIS Studies 1 and 2 the incidence of intracranial hemorrhageespecially symptomatic intracranial hemorrhage, was higher in Activase-treated patients than in placebo patients. Acute Ischemic Stroke Cerebral edema, cerebral herniation, seizure, new ischemic stroke.

Monitor patients treated with Cathflo Activase for signs of hypersensitivity and treat appropriately if necessary. Related Articles No related articles found. General Certain causes of catheter dysfunction should be considered before treatment with Cathflo Activase e.

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 e. Heart Disease Slideshow Pictures. Allergic Reactions Allergic-type reactions, e. Peel the clear plastic hanger from the vial label. Patients with prior activqse use were included. In patients without recent use of oral anticoagulants or heparinActivase treatment can be initiated prior to the availability of coagulation study results.

The incidence of intracranial hemorrhage in AMI patients treated with Activase is presented in Table 5. It is not known whether Activase is excreted in human milk.

Bleeding The most frequent adverse reaction associated with all thrombolytics in all approved indications is bleeding.

I, the first and corresponding author, verify my disclosures and those of my co-authors are up to date at http: Demographics and tPA exclusions were recorded. Program an infusion pump to deliver the appropriate volume as a bolus at the initiation of the infusion Administration Following bolus dose, if indicated [see Acute Ischemic Stroke and Acute Myocardial Infarction pafkage All fields are required.


The New Alteplase (tPA) Package Insert: What Is the Potential Impact? (P) | Neurology

If angioedema develops, discontinue the Activase infusion and promptly institute appropriate therapy e. Inspect parenteral drug products for particulate matter and discoloration prior to administration whenever solution and container permit. Efficacy results suggest a reduced but still favorable clinical outcome for Activase-treated elderly [see Clinical Studies ]. Lyerly has nothing to disclose. Neurology Apr86 16 Supplement P2.

Cholesterol Embolization Cholesterol embolism has been reported rarely in patients treated with thrombolytic agents; the true incidence is unknown.

Hypersensitivity, including urticaria, angioedema and anaphylaxis, has been reported in association with use of Cathflo Activase. When such reactions occur, they usually respond to conventional therapy. Hemorrhage can occur 1 or more days after administration of Activase, while patients are still receiving anticoagulant therapy. Pharmacokinetics Alteplase in acute myocardial infarction AMI patients is rapidly cleared from the plasma with an initial half-life of less than 5 minutes.

Aspirin and heparin have been administered concomitantly with and following infusions of Activase in the management of acute myocardial infarction and pulmonary embolism, but 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.

In a prespecified subgroup analysis of patients receiving aspirin prior to onset of stroke symptoms, the favorable outcome for Activase-treated patients was preserved. Activase is indicated for the lysis of acute massive pulmonary embolismdefined as:. Recent major surgery or procedure, e.