Pronunciation:

(ten EK te plase)

U.S. Brand Names:

Generic Available:

Canadian Brand Names:

Use:

Pregnancy Risk Factor:

Pregnancy Implications:

Lactation:

Contraindications:

Warnings/Precautions:

Adverse Reactions:

>10%:

Hematologic: Bleeding (22% minor: ASSENT-2 trial)

Local: Hematoma (12% minor)

1% to 10%:

Central nervous system: Stroke (2%)

Gastrointestinal: GI hemorrhage (1% major, 2% minor), epistaxis (2% minor)

Genitourinary: GU bleeding (4% minor)

Hematologic: Bleeding (5% major: ASSENT-2 trial)

Local: Bleeding at catheter puncture site (4% minor), hematoma (2% major)

Respiratory: Pharyngeal bleeding (3% minor)

<1%: Intracranial hemorrhage (0.9%), retroperitoneal bleeding, respiratory tract bleeding, anaphylaxis, angioedema, laryngeal edema, rash, urticaria, cholesterol embolism (clinical features may include livedo reticularis, "purple toe" syndrome, acute renal failure, gangrenous digits, hypertension, pancreatitis, MI, cerebral infarction, spinal cord infarction, retinal artery occlusion, bowel infarction, rhabdomyolysis), GU bleeding (<1% major), bleeding at catheter puncture site (<1% major)

Additional cardiovascular events associated with use in MI: Cardiogenic shock, arrhythmia, AV block, pulmonary edema, heart failure, cardiac arrest, recurrent myocardial ischemia, myocardial reinfarction, myocardial rupture, cardiac tamponade, pericarditis, pericardial effusion, mitral regurgitation, thrombosis, embolism, electromechanical dissociation, hypotension, fever, nausea, vomiting

Overdosage/Toxicology:

Drug Interactions:

Aminocaproic acid (antifibrinolytic agent) may decrease effectiveness.

Drugs which affect platelet function (eg, NSAIDs, dipyridamole, ticlopidine, clopidogrel, IIb/IIIa antagonists) may potentiate the risk of hemorrhage; use with caution.

Heparin and aspirin: Use with aspirin and heparin may increase bleeding. However, aspirin and heparin were used concomitantly with tenecteplase in the majority of patients in clinical studies.

Warfarin or oral anticoagulants: Risk of bleeding may be increased during concurrent therapy.

Stability:

Mechanism of Action:

Pharmacodynamics/Kinetics:

Distribution: Vd is weight related and approximates plasma volume

Metabolism: Primarily hepatic

Half-life elimination: 90-130 minutes

Excretion: Clearance: Plasma: 99-119 mL/minute

Dosage:

Adult: Recommended total dose should not exceed 50 mg and is based on patient's weight; administer as a bolus over 5 seconds

If patient's weight:

<60 kg, dose: 30 mg

60 to <70 kg, dose: 35 mg

70 to <80 kg, dose: 40 mg

80 to <90 kg, dose: 45 mg

90 kg, dose: 50 mg

All patients received 150-325 mg of aspirin as soon as possible and then daily. Intravenous heparin was initiated as soon as possible and aPTT was maintained between 50-70 seconds.

Dosage adjustment in renal impairment: No formal recommendations for renal impairment

Dosage adjustment in hepatic impairment: Severe hepatic failure is a relative contraindication. Recommendations were not made for mild to moderate hepatic impairment.

Elderly: Although dosage adjustments are not recommended, the elderly have a higher incidence of morbidity and mortality with the use of tenecteplase. The 30-day mortality in the ASSENT-2 trial was 2.5% for patients <65 years, 8.5% for patients 65-74 years, and 16.2% for patients 75 years. The intracranial hemorrhage rate was 0.4% for patients <65, 1.6 % for patients 65-74 years, and 1.7 % for patients 75. The risks and benefits of use should be weighted carefully in the elderly.

Administration:

Monitoring Parameters:

Patient Education:

Nursing Implications:

Anesthesia and Critical Care Concerns/Other Considerations:

Thrombolytic and GP llb/llla Inhibitor: It has been demonstrated that full-dose thrombolytic and full-dose GP llb/llla inhibitor result in patency, however, unacceptable bleeding (including cerebral bleeding) occurred.

Cardiovascular Considerations:

ST-Elevation Myocardial Infarction: The 2004 ACC/AHA guidelines for the management of patients with acute myocardial infarction recommend prehospital thrombolysis in special circumstances (eg, transport time >30 minutes). Efforts to quickly identify and safely treat appropriate candidates for therapy continue. Reducing treatment delays is very important to improve mortality. Thrombolytic therapy is indicated in patients with ST-segment elevation of >1 mm in two or more contiguous leads or at least 2 adjacent limb leads in patients with chest discomfort >30 minutes but 12 hours. Patients with chest discomfort suggestive of ischemia and new-onset left bundle branch block (LBBB) are also candidates for thrombolysis. Generally there is only a small trend for benefit of therapy after a delay of more than 12-24 hours, but thrombolysis may be considered for selected patients with ongoing ischemic pain and extensive ST elevation. Additional absolute contraindications for fibrinolysis use in ST-elevation myocardial infarction from the 2004 ACC/AHA guidelines: Any prior intracranial hemorrhage, ischemic stroke within 3 months (except one within 3 hours), significant closed head or facial trauma within 3 months. Additional relative contraindications include history of chronic severe, poorly-controlled hypertension, severe uncontrolled hypertension on presentation (systolic BP >180 mm Hg or diastolic >110 mm Hg; could be an absolute contraindication in low-risk patients), history of prior ischemic stroke > 3 months, dementia, or known intracranial pathology, traumatic or prolonged (>10 minutes) CPR or major surgery (<3 weeks), recent (within 2-4 weeks) internal bleeding, noncompressible vascular punctures, pregnancy, active peptic ulcer, current use of anticoagulants.

Thrombolytic and GP IIb/IIIa Inhibitor: In the GUSTO V trial, patients with acute MI were randomized to standard-dose reteplase or half-dose reteplase (two boluses of 5 units each, 30 minutes apart) and full dose abciximab. Thirty-day mortality (primary endpoint) was similar in both groups. The combination treatment group had fewer deaths or nonfatal reinfarctions, less need for urgent revascularization, fewer major ischemic complications. More bleeding occurred in the combination treatment group, but intracranial hemorrhage and nonfatal disabling stroke were similar in both groups. All cause mortality at one year was similar in both groups. In TIMI 14, the combination of full-dose abciximab (0.25 mg/kg bolus followed by a 12-hour infusion of 0.125 mcg/kg/minute, maximum 10 mcg/minute) and half-dose alteplase (15 mg bolus followed by 35 mg infusion over 60 minutes) resulted in 74% of patients achieving TIMI grade 3 flow at 90 minutes. The 2004 ACC/AHA guidelines for the management of patients with acute myocardial infarction suggests that abciximab and half-dose reteplase or tenecteplase may be considered for prevention of reinfarction in patients with an anterior MI, who <75 years of age and have no risk factors for bleeding.

Dental Health: Effects on Dental Treatment:

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

Mental Health: Effects on Mental Status:

Mental Health: Effects on Psychiatric Treatment:

Dosage Forms:

International Brand Names: