TENECTEPLASE RECOMBINANT

TENECTEPLASE RECOMBINANT
(ten-ect'e-plase)
TNKase
Classifications: thrombolytic enzyme, tissue plasminogen activator;
Therapeutic: thrombolytic enzyme

Prototype: Alteplase
Pregnancy Category: C

Availability

50 mg vial

Action

Tenecteplase is a third generation thrombolytic agent with advantages over alteplase, including longer half-life, more rapid thrombolysis, and greater fibrin specificity. Additionally, rate of noncerebral bleeding is less than in alteplase. Activates plasminogen, a substance created by endothelial cells in response to arterial wall injury that contributes to clot formation. Plasminogen is converted to plasmin which breaks down the fibrin mesh that binds the clot together, thus dissolving the clot.

Therapeutic Effect

Effective in producing thrombolysis of a clot involved in a myocardial infarction.

Uses

Reduction of mortality associated with acute myocardial infarction (AMI).

Contraindications

Active internal bleeding; history of CVA; intracranial or intraspinal surgery with 2 mo; intracranial neoplasm; arteriovenous malformation, or aneurysm; known bleeding diathesis; brain tumor; increased intracranial pressure; coagulopathy; head trauma; stroke; surgery; severe uncontrolled hypertension; pregnancy (category C), lactation.

Cautious Use

Recent major surgery, previous puncture of compressible vessels, CVA, recent GI or GU bleeding, recent trauma; hypertension, mitral valve stenosis, acute pericarditis, bacterial endocarditis; severe liver or kidney disease; hemorrhagic ophthalmic conditions; septic thrombophlebitis or occluded, infected AV cannula; advanced age; concurrent administration of oral anticoagulants, recent administration of GP IIb/IIIa inhibitors, condition involving bleeding. Safety and efficacy in children are not established.

Route & Dosage

Acute Myocardial Infarction
Adult: IV Infuse dose over 5 sec, <60 kg, 30 mg; 60–70 kg, 35 mg; 70–80 kg, 40 mg; 80–90 kg, 45 mg; >90 kg, 50 mg

Administration

Intravenous

PREPARE: Direct: Read and follow instructions supplied with TwinPakTM Dual Cannula Device. Withdraw 10 mL of sterile water for injection from the supplied vial; inject entire contents into the TNKase vial directing the diluent stream into the powder. Gently swirl until dissolved but do not shake. The resulting solution contains 5 mg/mL. Withdraw the appropriate dose and discard any unused solution. Follow directions supplied with TwinPakTM for proper handling of syringe.  

ADMINISTER: Direct: Dextrose-containing IV line must be flushed before and after bolus with NS. Give as a single bolus dose over 5 sec. The total dose given should not exceed 50 mg.  

INCOMPATIBILITIES Solution/additive: Dextrose solutions.

  • Store unopened TwinPakTM at ≤30° C (86° F) or under refrigeration at 2°–8° C (36°–46° F).

Adverse Effects (≥1%)

Hematologic: Major bleeding, hematoma, GI bleed, bleeding at puncture site, hematuria, pharyngeal, epistaxis.

Diagnostic Test Interference

Unreliable results for coagulation test I and measures of fibrinolytic activity.

Pharmacokinetics

Metabolism: In liver. Half-Life: 90–130 min.

Nursing Implications

Assessment & Drug Effects

  • Avoid IM injections and unnecessary handling or invasive procedures for the first few hours after treatment.
  • Monitor for S&S of bleeding. Should bleeding occur, discontinue concomitant heparin and antiplatelet therapy; notify physician.
  • Monitor cardiovascular and neurologic status closely. Persons at increased risk for life-threatening cardiac events include those with: A high potential for bleeding, recent surgery, severe hypertension, mitral stenosis and atrial fibrillation, anticoagulant therapy, and advanced age.
  • Lab tests: Baseline and 1 h after administration of drug determine cardiac enzymes, circulating myoglobin, cardiac troponin-1, creatine kinase-MB; Hgb & Hct post-infusion.
  • Coagulation parameters may not predict bleeding episodes.

Patient & Family Education

  • Notify physician of the following immediately: A sudden, severe headache; any sign of bleeding; signs or symptoms of hypersensitivity (see Appendix F).
  • Stay as still as possible and do not attempt to get out of bed until directed to do so.

Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug

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