tenecteplase: clinical use

Prescribing considerations

• Restrict use to clinicians experienced in coronary or neurovascular thrombolysis, with resuscitation and monitoring facilities available.
• Confirm the indication and corresponding presentation; the myocardial-infarction presentation is not intended for acute ischaemic stroke.
• For stroke, exclude intracranial haemorrhage by imaging and assess stroke severity, blood pressure, glucose, anticoagulant exposure and recent procedures or trauma.
• Minimise non-essential handling, intramuscular injections and vascular punctures.
• Record the product name and batch number for biological-medicine traceability.
• Do not use as routine pretreatment when primary percutaneous coronary intervention is already planned.

Contraindications and cautions

• Hypersensitivity to tenecteplase, an excipient or trace gentamicin residue
• Current or recent significant bleeding disorder, known bleeding tendency or effective anticoagulation
• Known or suspected intracranial haemorrhage or relevant intracranial disease
• Severe uncontrolled hypertension
• Recent major surgery, significant trauma, head injury or another procedure carrying substantial bleeding risk
• Severe hepatic dysfunction, active ulcerative gastrointestinal disease, bleeding-risk neoplasm, aneurysm or vascular malformation
• Bacterial endocarditis, pericarditis or acute pancreatitis
• Additional indication-specific exclusions, including defined previous-stroke histories and certain stroke presentations

Monitoring

• Inspect puncture sites and monitor for external or internal bleeding.
• Perform frequent neurological observations after stroke treatment and investigate deterioration urgently.
• Monitor blood pressure closely after stroke thrombolysis.
• Observe for hypersensitivity and angio-oedema during and after administration.
• Monitor cardiac rhythm and haemodynamic status during myocardial-infarction care.
• If major bleeding occurs, reassess haemoglobin, coagulation and fibrinogen and manage associated antithrombotic treatment promptly.

Clinical pharmacology

Tenecteplase is a modified recombinant tissue plasminogen activator with increased fibrin specificity and resistance to plasminogen-activator inhibitor-1. It is cleared mainly through hepatic receptor binding and subsequent protein breakdown.

Formulation and product differences

• The 10,000-unit (50 mg) product contains powder, a pre-filled solvent syringe and vial adapter and is intended for acute myocardial infarction.
• The 5,000-unit (25 mg) powder vial requires sterile water for injection that is not supplied and is intended for acute ischaemic stroke.
• Both form an intravenous solution after reconstitution and are incompatible with glucose infusion solutions.

Injection

Route: Parenteral

Strengths: 25 mg, 5000 units