Pricing
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Metalyse is indicated for:
Pharmacology
Tenecteplase is a recombinant, fibrin-specific plasminogen activator. It is made from native t-PA by changing the protein structure at three sites. The medicine binds to the fibrin part of the thrombus (blood clot) and converts the plasminogen bound to the thrombus into plasmin, which breaks down the fibrin matrix of the clot.
Compared with native t-PA, tenecteplase has a higher fibrin specificity and resists inactivation by its natural inhibitor, PAI-1, better. It attaches to fibrin-rich clots through the fibronectin finger-like domain and the Kringle 2 domain. The protease domain then cleaves the Arg/Val bond in plasminogen to form plasmin. Plasmin in turn degrades the fibrin matrix of the thrombus, and this is how tenecteplase produces its thrombolytic action.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Detailed dosing reference is not available yet. Please follow your prescription and consult your pharmacist.
Side Effects
Bleeding is the most frequent side effect of Tenecteplase. If serious bleeding happens, any heparin and antiplatelet therapy given at the same time should be stopped. Patients who have a stroke or a serious bleeding episode can die or be left with permanent disability. In ASSENT-2, intracranial hemorrhage occurred in 0.9% of the patients treated with Tenecteplase, and any stroke in 1.8%. The incidence of all strokes, including intracranial bleeding, rises with increasing age. Non-intracranial major bleeding and the need for blood transfusions were lower in the treated patients. Types of major bleeding reported in 1% or more of the patients were hematoma (1.7%) and gastrointestinal tract (1%). Types of major bleeding reported in less than 1% were urinary tract, puncture site (including cardiac catheterization site), retroperitoneal, respiratory tract, and unspecified. Types of minor bleeding reported in 1% or more of the patients were hematoma (12.3%), urinary tract (3.7%), puncture site (including cardiac catheterization site) (3.6%), pharyngeal (3.1%), gastrointestinal tract (1.9%), epistaxis (1.5%), and unspecified (1.3%). Some other adverse reactions have been reported in patients receiving the medicine in clinical trials. These are frequent sequelae of the underlying disease, and the effect of Tenecteplase on how often they happen is unknown. They include cardiogenic shock, arrhythmias, atrioventricular block, pulmonary edema, heart failure, cardiac arrest, recurrent myocardial ischemia, myocardial reinfarction, myocardial rupture, cardiac tamponade, pericarditis, pericardial effusion, mitral regurgitation, thrombosis, embolism, and electromechanical dissociation. These events can be life-threatening and may lead to death. Nausea and/or vomiting, hypotension, and fever have also been reported.
Cautions & Contraindications
Warnings & Precautions
Standard treatment for myocardial infarction should be given together with Tenecteplase. Keep arterial and venous punctures to a minimum. Noncompressible arterial puncture must be avoided, and internal jugular and subclavian venous punctures should be avoided too, so that bleeding from sites that can't be compressed is kept down. If serious bleeding happens, stop heparin and antiplatelet agents immediately. Protamine can reverse the effects of heparin. Hypersensitivity reactions, including urticarial and anaphylactic reactions, have been reported after Tenecteplase was given (for example anaphylaxis, angioedema, laryngeal edema, rash and urticaria). Patients treated with Tenecteplase should be monitored during the infusion and for several hours afterwards. If symptoms of hypersensitivity occur, start appropriate therapy.
Contraindications
Tenecteplase must not be given to people with active internal bleeding, or a history of cerebrovascular accident. It is also not for those who have had intracranial or intraspinal surgery, or trauma, within 2 months. Other contraindications are intracranial neoplasm, arteriovenous malformation or aneurysm, a known bleeding diathesis, and severe uncontrolled hypertension.
Pregnancy & Breastfeeding
If a woman has a myocardial infarction during pregnancy, the doctor has to weigh the benefit of treatment against the possible risks. Nobody knows whether tenecteplase passes into breast milk. Because many drugs do pass into human milk, a nursing woman should be given tenecteplase with caution.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Pediatric use
The safety and effectiveness of Tenecteplase in pediatric patients have not been established.
Geriatric use
In the ASSENT-2 trial, 4,958 patients (59%) who received Tenecteplase were under 65. Another 2,256 (27%) were between 65 and 74, and 1,244 (15%) were 75 and over.
The 30-day mortality rate was 2.5% in patients under 65, 8.5% in those between 65 and 74, and 16.2% in those aged 75 and over. ICH rates were 0.4% in patients under 65, 1.6% in the 65 to 74 group, and 1.7% in patients aged 75 and over. For any stroke, the rates were 1.0% under 65, 2.9% between 65 and 74, and 3.0% at 75 and over.
Major bleeding means bleeding that needs a blood transfusion or leads to hemodynamic compromise. The rates were 3.1% in patients under 65, 6.4% in those between 65 and 74, and 7.7% in patients aged 75 and over.
In elderly patients, the benefits of Tenecteplase on mortality should be carefully weighed against the risk of increased adverse events, including bleeding.
Overdose
If too much Tenecteplase is given, the risk of bleeding may go up. When the bleeding is severe and goes on for a long time, replacement therapy with plasma or platelets may be considered.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep lyophilized Tenecteplase at a temperature not above 30°C, or in a refrigerator at 2 to 8°C. Keep it out of reach of children.
Common questions about Metalyse 5 mg/ml
What is Metalyse 5 mg/ml IV Injection?
Metalyse 5 mg/ml IV Injection is a medicine that contains Tenecteplase. It is made by Radiant Pharmaceuticals Ltd. It belongs to the Fibrinolytics (Thrombolytics) group of medicines.
What is Metalyse used for?
Metalyse is used for: Myocardial Infarction.
What are the side effects of Metalyse?
Bleeding is the most frequent side effect of Tenecteplase. If serious bleeding happens, any heparin and antiplatelet therapy given at the same time should be stopped.
Can I take Metalyse during pregnancy or while breastfeeding?
If a woman has a myocardial infarction during pregnancy, the doctor has to weigh the benefit of treatment against the possible risks. Nobody knows whether tenecteplase passes into breast milk. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Metalyse?
If too much Tenecteplase is given, the risk of bleeding may go up. When the bleeding is severe and goes on for a long time, replacement therapy with plasma or platelets may be considered. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Metalyse?
Keep lyophilized Tenecteplase at a temperature not above 30°C, or in a refrigerator at 2 to 8°C. Keep it out of reach of children.
Do I need a prescription for Metalyse?
Metalyse is a prescription (Rx) medicine. Take it as your doctor advises.