METALYSE

What it is

METALYSE is available in 40 mg and 50 mg strengths as a sterile, white to off-white, lyophilised powder for single intravenous bolus administration after reconstitution with sterile Water for Injections. The reconstituted solution contains 5 mg (1,000 U) tenecteplase per mL. The potency of METALYSE is expressed in Units (U) based on a reference standard specific for tenecteplase, and this unit is not comparable with units used for other thrombolytic agents.

Approved indications

— Thrombolytic treatment of the acute phase of myocardial infarction.

Dosing overview

METALYSE should be administered on the basis of body weight, with a maximum dose of 50 mg (10,000 U). For acute myocardial infarction, patients weighing less than 60 kg receive 6,000 U (30 mg); those weighing 60 to less than 70 kg receive 7,000 U (35 mg); those weighing 70 to less than 80 kg receive 8,000 U (40 mg); those weighing 80 to less than 90 kg receive 9,000 U (45 mg); and those weighing 90 kg or more receive 10,000 U (50 mg). The required dose should be administered as a single intravenous bolus over approximately 10 seconds. METALYSE should be administered with caution in elderly patients (≥ 75 years) due to a higher bleeding risk.

Key safety warnings

The most common complication encountered during METALYSE therapy is bleeding. Bleeding can be internal at any site or body cavity, or superficial or surface bleeding observed mainly at vascular puncture and access sites or sites of recent surgical intervention. Should serious bleeding not controlled by local pressure occur, any concomitant heparin or antiplatelet agents should be discontinued immediately. Coronary thrombolysis may result in arrhythmia associated with reperfusion, which may lead to cardiac arrest, can be life-threatening and may require conventional antiarrhythmic therapies. Cholesterol embolism has been reported rarely in patients treated with all types of thrombolytic agents; this serious condition, which can be lethal, is also associated with invasive vascular procedures and anticoagulant therapy, and clinical features may include livedo reticularis, purple toe syndrome, acute renal failure, gangrenous digits, hypertension, pancreatitis, myocardial infarction, cerebral infarction, spinal cord infarction, retinal artery occlusion, bowel infarction, and rhabdomyolysis. Anaphylactoid reactions associated with the administration of METALYSE are rare and can be caused by hypersensitivity to the active substance tenecteplase, gentamicin (a trace residue from the manufacturing process) or to any of the excipients.

Contraindications

METALYSE is contraindicated in patients with significant bleeding disorder either at present or within the past 6 months; those receiving effective oral anticoagulant treatment such as warfarin sodium (INR > 1.3); any history of central nervous system damage; known haemorrhagic diathesis; severe uncontrolled hypertension (systolic > 180 mm Hg and/or diastolic > 110 mm Hg); major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months; recent trauma to the head or cranium; prolonged or traumatic cardiopulmonary resuscitation (> 2 minutes) within the past 2 weeks; severe hepatic dysfunction including hepatic failure, cirrhosis, portal hypertension and active hepatitis; active peptic ulceration during the last 3 months; arterial aneurysm and known arterial or venous malformation; neoplasm with increased bleeding risk; haemorrhagic stroke or stroke of unknown origin at any time; ischaemic stroke or transient ischaemic attack in the preceding 6 months; patients receiving other intravenous thrombolytic agents; subacute bacterial endocarditis; acute pericarditis; acute pancreatitis; recent gastrointestinal or genitourinary bleeding within 10 days; recent obstetrical delivery, organ biopsy, or puncture of non-compressible blood vessel within 10 days; and haemostatic defects including those secondary to severe hepatic or renal disease. METALYSE is not for use in patients with known hypersensitivity to the active substance tenecteplase, gentamicin or any of the excipients.

Regulatory history

METALYSE tenecteplase 40 mg and 50 mg powder for injection were first registered on the ARTG on 9 November 2000. METALYSE tenecteplase 25 mg powder for injection was first registered on the ARTG on 15 July 2025.