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Metalyse is a brand name for Tenecteplase. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Metalyse is indicated in adults for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left Bundle Branch Block within 6 hours after the onset of acute myocardial infarction (AMI) symptoms.
Verbatim from this product's EMA label. Tap a section to expand.
Posology Metalyse should be prescribed by physicians experienced in the use of thrombolytic treatment and with the facilities to monitor that use. Treatment with Metalyse should be initiated as early as possible after onset of symptoms.
3 The appropriate presentation of tenecteplase product should be chosen carefully and in line with the indication. The 40 mg and 50 mg presentations are only intended for use in acute myocardial infarction. Metalyse should be administered on the basis of body weight, with a maximum dose of 10 000 units (50 mg tenecteplase).
1). Paediatric population The safety and efficacy of Metalyse in children (below 18 years) have not been established. No data are available. Adjunctive therapy Antithrombotic adjunctive therapy with platelet inhibitors and anticoagulants should be administered according to the current relevant treatment guidelines for the management of patients with ST-elevation myocardial infarction.
For coronary intervention see section
Summary of the safety profile Haemorrhage is a very common undesirable effect associated with the use of tenecteplase. The type of haemorrhage is predominantly superficial at the injection site. Ecchymoses are observed commonly but usually do not require any specific action.
Death and permanent disability are reported in patients who have experienced stroke (including intracranial bleeding) and other serious bleeding episodes. Tabulated list of adverse reactions Adverse reactions listed below are classified according to frequency and system organ class.
Frequency groupings are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000), not known (cannot be estimated from the available data).
7 Table 1 displays the frequency of adverse reactions. System organ class Adverse reaction Immune system disorders Rare Anaphylactoid reaction (including rash, urticaria, bronchospasm, laryngeal oedema) Nervous system disorders Uncommon Intracranial haemorrhage (such as cerebral haemorrhage, cerebral haematoma, haemorrhagic stroke, haemorrhagic transformation stroke, intracranial haematoma, subarachnoid haemorrhage) including associated symptoms as somnolence, aphasia, hemiparesis, convulsion Eye disorders Uncommon Eye haemorrhage Cardiac disorders Uncommon Reperfusion arrhythmias (such as asystole, accelerated idioventricular arrhythmia, arrhythmia, extrasystoles, atrial fibrillation, atrioventricular first degree to atrioventricular block complete, bradycardia, tachycardia, ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia) occur in close temporal relationship to treatment with tenecteplase.
Rare Pericardial haemorrhage Vascular disorders Very common Haemorrhage Rare Embolism (thrombotic embolisation) Respiratory, thoracic and mediastinal disorders Common Epistaxis Rare Pulmonary haemorrhage Gastrointestinal disorders Common Gastrointestinal haemorrhage (such as gastric haemorrhage, gastric ulcer haemorrhage, rectal haemorrhage, haematemesis, melaena, mouth haemorrhage) Uncommon Retroperitoneal haemorrhage (such as retroperitoneal haematoma) Not known Nausea, vomiting Skin and subcutaneous tissue disorders Common Ecchymosis Renal and urinary disorders Common Urogenital haemorrhage (such as haematuria, haemorrhage urinary tract) General disorders and administration site conditions Common Injection site haemorrhage, puncture site haemorrhage Investigations Rare Blood pressure decreased Not known Body temperature increased Injury, poisoning and procedural complications Not known Fat embolism, which may lead to corresponding consequences in the organs concerned As with other thrombolytic agents, the following events have been reported as sequelae of myocardial infarction and/or thrombolytic administration: − very common: hypotension, heart rate and rhythm disorders, angina pectoris − common: recurrent ischaemia, cardiac failure, myocardial infarction, cardiogenic shock, pericarditis, pulmonary oedema 8 − uncommon: cardiac arrest, mitral valve incompetence, pericardial effusion, venous thrombosis, cardiac tamponade, myocardial rupture − rare: pulmonary embolism These cardiovascular events can be life-threatening and may lead to death.
4. Unfractionated heparin and enoxaparin have been used as antithrombotic adjunctive therapy in clinical studies with Metalyse. Acetylsalicylic acid should be initiated as soon as possible after symptom onset and continued with lifelong treatment unless it is contraindicated.
Method of administration The reconstituted solution should be administered intravenously and is for immediate use. The reconstituted solution is a clear and colourless to slightly yellow solution. The required dose should be administered as a single intravenous bolus over approximately 10 seconds.
6. 1 or to gentamicin (a trace residue from the manufacturing process). If treatment with Metalyse is nevertheless considered to be necessary, facilities for resuscitation should be immediately available in case of need. g. e. 4 Special warnings and precautions for use Traceability In order to improve the traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded.
1 ASSENT-4 study) should not be given. 1 STREAM study). Bleeding The most common complication encountered during tenecteplase therapy is bleeding. The concomitant use of heparin anticoagulation may contribute to bleeding. As fibrin is lysed during tenecteplase therapy, bleeding from recent puncture site may occur.
Therefore, thrombolytic therapy requires careful attention to all possible bleeding sites (including catheter insertion sites, arterial and venous puncture sites, cutdown sites and needle puncture sites). The use of rigid catheters as well as intramuscular injections and non-essential handling of the patient should be avoided during treatment with tenecteplase.
Most frequently haemorrhage at the injection site, and occasionally genitourinary and gingival bleeding were observed. Should serious bleeding occur, in particular cerebral haemorrhage, concomitant heparin administration should be terminated immediately.
1 or to gentamicin (a trace residue from the manufacturing process). If treatment with Metalyse is nevertheless considered to be necessary, facilities for resuscitation should be immediately available in case of need. g. e. 4) - Major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (this includes any trauma associated with the current AMI) - Recent trauma to the head or cranium - Bacterial endocarditis, pericarditis - Acute pancreatitis - Severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis - Active ulcerative gastro-intestinal disease - Known arterial aneurysm and/or arterial/venous malformation - Neoplasm with increased bleeding risk - Any known history of haemorrhagic stroke or stroke of unknown origin - Known history of ischaemic stroke or transient ischaemic attack in the preceding 6 months - Dementia
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Tenecteplase in European Union.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Administration of protamine should be considered if heparin has been administered within 4 hours before the onset of bleeding. In the few patients who fail to respond 5 to these conservative measures, judicious use of transfusion products may be indicated.
Transfusion of cryoprecipitate, fresh frozen plasma, and platelets should be considered with clinical and laboratory reassessment after each administration. A target fibrinogen level of 1 g/L is desirable with cryoprecipitate infusion.
Antifibrinolytic agents are available as a last alternative. e. g. 3 for vitamin K antagonists or other relevant test(s) for other oral anticoagulants are within the respective upper limit of normal) - Prolonged (> 2 minutes) or traumatic cardiopulmonary resuscitation or cardiac massage Arrhythmias Coronary thrombolysis may result in arrhythmias associated with reperfusion.
Reperfusion arrhythmias may lead to cardiac arrest, can be life threatening and may require the use of conventional antiarrhythmic therapies. It is recommended that antiarrhythmic therapy for bradycardia and/or ventricular tachyarrhythmias (pacemaker, defibrillator) is available when tenecteplase is administered.
GPIIb/IIIa antagonists Concomitant use of GPIIb/IIIa antagonists increases bleeding risk. […]