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a tissue plasminogen activator produced by recombinant DNA technology; used in therapy for acute myocardial infarction, acute ischemic stroke, and acute pulmonary embolism, administered intravenously.

alteplase (tissue plasminogen activator, recombinant)

Actilyse (UK), Activase, Activase rt-PA (CA), Cathflo Activase

Pharmacologic class: Plasminogen activator

Therapeutic class: Thrombolytic

Pregnancy risk category C


Converts plasminogen to plasmin, which in turn breaks down fibrin and fibrinogen, thereby dissolving thrombus


Injection: 2-mg single-patient vials; 50-mg, 100-mg vials

Indications and dosages

Lysis of thrombi obstructing coronary arteries in acute myocardial infarction (MI)

3-hour infusion-

Adults: 100 mg I.V. over 3 hours as follows: 60 mg over first hour (give 6 to 10 mg as bolus over first 1 to 2 minutes), then 20 mg I.V. over second hour, then 20 mg I.V. over third hour

Adults weighing less than 65 kg (143 lb): 1.25 mg/kg I.V. in divided doses over 3 hours, not to exceed 100 mg Accelerated infusion-

Adults weighing more than 67 kg (147 lb): Give total dosage of 100 mg as follows: 15 mg I.V. bolus over 1 to 2 minutes, then 50 mg I.V. over next 30 minutes, then 35 mg I.V. over next 60 minutes.

Adults weighing 67 kg (147 lb) or less: 15 mg I.V. bolus over 1 to 2 minutes, followed by 0.75 mg/kg I.V. over next 30 minutes (not to exceed 50 mg), followed by 0.5 mg/kg I.V. over next hour, not to exceed 35 mg

Acute ischemic cerebrovascular accident (CVA)

Adults: 0.9 mg/kg I.V. over 1 hour, to a maximum dosage of 90 mg, with 10% of total dosage given as I.V. bolus within first minute

Acute massive pulmonary embolism

Adults: 100 mg I.V. over 2 hours, followed by heparin

Restoration of function of central venous access device

Adults weighing 30 kg (66 lb) or more: Cathflo Activase-2 mg/2-ml concentration instilled in dysfunctional catheter. If catheter function isn't restored in 120 minutes after first dose, may give second dose.

Adults weighing 10 kg (22 lb) to less than 30 kg: Cathflo Activase-Use 110% of catheter lumen volume not to exceed 2 mg/2-ml concentration instilled in dysfunctional catheter. If catheter function isn't restored in 120 minutes after first dose, may give second dose.

Off-label uses

• Small-vessel occlusion by microthrombi

• Peripheral arterial thromboembolism


• Hypersensitivity to drug or its components (Cathflo Activase)

• Seizures, stroke, aneurysm, intracranial neoplasm, bleeding diathesis


Use cautiously in:

• hypersensitivity to anistreplase or streptokinase

• GI or genitourinary bleeding, ophthalmic hemorrhage, organ biopsy, severe hepatic or renal disease

• elderly patients

• pregnant or breastfeeding patients

• children.


Be aware that intracranial hemorrhage must be ruled out before therapy begins.

To treat acute ischemic CVA, give within 3 hours of initial signs or symptoms.

If uncontrolled bleeding occurs, stop infusion and notify prescriber immediately.

• Give I.V. only, using controlled-infusion pump.

• Reconstitute with unpreserved sterile water for injection. May be further diluted with normal saline solution or D5W.

Adverse reactions

CNS: cerebral hemorrhage, cerebral edema, CVA (with accelerated infusion)

CV: hypotension, bradycardia, recurrent ischemia, pericardial effusion, pericarditis, mitral regurgitation, electromechanical dissociation, arrhythmias, cardiogenic shock, heart failure, cardiac arrest, cardiac tamponade, myocardial rupture, embolization, venous thrombosis

GI: nausea, vomiting, GI bleeding

GU: GU tract bleeding

Hematologic: spontaneous bleeding, bone marrow depression

Musculoskeletal: musculoskeletal pain

Respiratory: pulmonary edema

Skin: bruising, flushing

Other: fever, edema, phlebitis or bleeding at I.V. site, hypersensitivity reaction (including rash, anaphylactic reaction, laryngeal edema), sepsis


Drug-drug. Aspirin, drugs affecting platelet activity (such as abciximab, heparin, dipyridamole, oral anticoagulants, vitamin K antagonists): increased risk of bleeding

Drug-diagnostic tests. Blood urea nitrogen: elevated level

Patient monitoring

• Monitor vital signs, ECG, and neurologic status.

• Maintain strict bed rest.

• Watch for signs and symptoms of bleeding tendency and hemorrhage.

• Monitor patient on Cathflo Activase for GI bleeding, venous thrombosis, and sepsis.

• Evaluate results of clotting studies.

Patient teaching

• As appropriate, explain therapy and monitoring to patient and family.


A tissue plasminogen activator made by recombinant DNA technology, used as a thrombolytic.


/al·te·plase/ (al´tĕ-plās) a tissue plasminogen activator produced by recombinant DNA technology; used in fibrinolytic therapy for acute myocardial infarction and as a thrombolytic in the treatment of acute ischemic stroke and pulmonary embolism.


a tissue plasminogen activator.
indications This drug is used for lysis of obstructing thrombi associated with acute MI and for other ischemic conditions requiring thrombolysis.
contraindications Known hypersensitivity to this drug, active internal bleeding, recent cerebrovascular accident, severe uncontrolled hypertension, intracranial trauma or surgery, intraspinal trauma or surgery, aneurysm, and brain tumor prohibit the use of this drug.
adverse effects Adverse effects of this drug include urticaria and rash. Surface bleeding is a common side effect. Life-threatening side effects include sinus bradycardia, ventricular tachycardia, accelerated idioventricular rhythm, bradycardia, GI bleeding, genitourinary bleeding, intracranial bleeding, retroperitoneal bleeding, and anaphylaxis.


Activase® Cardiology A thrombolytic used to manage and prevent pulmonary embolism. See Pulmonary embolism, Thrombolytic therapy.


A TISSUE PLASMINOGEN ACTIVATOR drug made by recombinant DNA technology. In mid-2003 the drug was approved for the treatment of ischaemic stroke by experts. It must be given within three hours and cerebral haemorrhage must be excluded. A brand name is Actilyse.
References in periodicals archive ?
The safest and most effective dose of Cathflo Activase required to treat catheter-related thrombosis in infants and children remains to be determined.
As discussed, Cathflo Activase has been quite recently approved by the FDA.
Products of the company are marketed under various brand names such as Activase, Avastin, Cathflo Activase, Rituxan, Xolair, Tarceva, Pulmozyme, Genentech, Herceptin, Lucentis, Raptiva, TNKase and Nutropin among others.
Witt, who joined Kane and Finkel in 2003, is a seasoned healthcare communications professional with significant expertise in the multi-faceted thrombolytic market, including directing the TNKase and Cathflo Activase product launches.
Along with solid sales performances from our marketed products, Rituxan and Herceptin, we made progress in moving projects through our pipeline, including the approval and launch of Cathflo Activase.
Cathflo Activase Now the Only Marketed Available Thrombolytic Agent
Cathflo Activase, available in a 2 mg single-patient-use vial, is the only marketed thrombolytic available for this indication and offers medical professionals a viable treatment option for a CVAD complication that can hinder patient care.
The approval of Cathflo Activase provides Genentech an opportunity to address an important medical need for patients who rely on central venous access devices for their medical care, and represents an excellent business opportunity to expand our successful Activase cardiovascular franchise into a new arena," said Arthur D.
The availability of Cathflo Activase may help patients avoid surgical removal and replacement of blocked CVADs," said COOL-2 pivotal trial lead investigator Steven R.
Cathflo Activase works by activating plasminogen, which dissolves fibrin (a substance that causes blood to clot), breaking down the thrombus and restoring function to the CVAD.
FDA approval of Cathflo Activase is based on two Phase III clinical trials designed to assess its safety and efficacy in restoring function to CVADs that had become occluded due to a blood clot: the COOL (Cardiovascular thrombolytic to Open Occluded Lines) efficacy trial and the COOL-2 safety trial.
In this study, Cathflo Activase or placebo was instilled directly into the lumen opening (tube of the catheter that carries fluid through a CVAD directly to the vein), for a dwell time of 120 minutes.