Product image of Metalyse (Tenecteplase) supplied by GNH India

Metalyse

Active Ingredient:
Tenecteplase
Origin:
EU

Metalyse (Tenecteplase)

Tenecteplase, the active ingredient in Metalyse, is a thrombolytic agent presented as a lyophilized powder for solution for injection for intravenous use. It treats acute ST‑elevation myocardial infarction (STEMI) in adult patients by rapidly dissolving clots and restoring coronary blood flow.

GNH India supplies Metalyse as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals worldwide. The company adheres to stringent quality standards and provides reliable logistics for global distribution to healthcare facilities. Clients benefit from comprehensive regulatory support and on‑time delivery across continents.

Manufacturer / TM Owner

Boehringer Ingelheim International Gmbh

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Indications & Clinical Uses

Tenecteplase is a fibrinolytic drug used in the acute coronary syndrome pathway to dissolve occlusive thrombi.

  • Acute ST‑elevation myocardial infarction (STEMI): rapid restoration of coronary blood flow and reduction of infarct size.
  • High‑risk STEMI presenting within 12 hours: improves survival when administered promptly.
  • Late‑presenting STEMI (12–24 hours): facilitates reperfusion in patients unsuitable for primary PCI.
  • Adjunct to primary PCI when delays occur: provides early thrombolysis to limit myocardial damage.
  • Bridge therapy for patients awaiting transfer to PCI‑capable centre: maintains patency of the coronary artery.

How It Works

  • Tenecteplase is a genetically modified variant of tissue‑type plasminogen activator that binds fibrin‑rich thrombi with high affinity. Once bound, it converts circulating plasminogen to active plasmin, which enzymatically degrades fibrin strands, leading to dissolution of the clot while sparing systemic fibrinogen. The modification reduces interaction with plasma protease inhibitors, enhancing its clot‑targeted activity and allowing a rapid, single‑dose regimen in acute myocardial infarction.

Side Effects

Tenecteplase may cause a range of adverse reactions, most of which are related to its fibrinolytic activity.

Common Side Effects

  • Bleeding at injection site: mild to moderate bruising or hematoma.
  • Hemorrhage: gastrointestinal or urinary tract bleeding.
  • Hypotension: transient drop in blood pressure.
  • Nausea or vomiting: mild gastrointestinal upset.
  • Headache: often mild and self‑limiting.
  • Fever or chills: transient pyrexia.

Serious or Rare Side Effects

  • Intracranial hemorrhage: life‑threatening bleeding in the brain.
  • Allergic reaction or anaphylaxis: severe hypersensitivity requiring immediate treatment.
  • Myocardial rupture: rare tearing of heart muscle post‑infarction.
  • Severe hypotension: profound drop in blood pressure causing shock.
  • Disseminated intravascular coagulation: abnormal clotting and bleeding throughout the body.

Precautions & Warnings

When using Tenecteplase, clinicians should observe several precautionary measures to minimize bleeding risk and ensure safe administration.

  • Assess bleeding risk: evaluate recent surgery, trauma, or active hemorrhage before administration.
  • Review contraindications: avoid use in patients with known intracranial hemorrhage or uncontrolled hypertension.
  • Monitor coagulation parameters: check PT/INR and platelet count during therapy.
  • Observe vital signs: continuous blood pressure and heart rate monitoring after infusion.
  • Use caution in elderly: dose adjustments may be required due to increased bleeding susceptibility.
  • Store at 2‑8 °C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Tenecteplase interacts with several agents that affect hemostasis or fibrinolysis, requiring careful management.

Major Interactions (Avoid)

  • Concurrent thrombolytics: combined use markedly increases risk of severe bleeding.
  • Therapeutic anticoagulants (e.g., heparin, low‑molecular‑weight heparin, warfarin): additive anticoagulant effect may cause life‑threatening hemorrhage.
  • Direct oral anticoagulants (e.g., dabigatran, rivaroxaban): similar heightened bleeding risk.

Moderate Interactions (Monitor Closely)

  • Antiplatelet agents (e.g., aspirin, clopidogrel, GP IIb/IIIa inhibitors): may increase minor bleeding; monitor platelet function.
  • Non‑steroidal anti‑inflammatory drugs (NSAIDs): can impair platelet aggregation, requiring observation.
  • Selective serotonin reuptake inhibitors (SSRIs): may modestly raise bleeding tendency; assess risk‑benefit.

Frequently Asked Questions

Metalyse contains tenecteplase, a thrombolytic agent indicated for the rapid dissolution of clots in patients experiencing an acute ST‑elevation myocardial infarction (STEMI). It is used to restore coronary blood flow and limit heart‑muscle damage when administered promptly.

Tenecteplase is a modified tissue‑type plasminogen activator that binds preferentially to fibrin within a clot. Once attached, it converts circulating plasminogen into plasmin, an enzyme that degrades fibrin strands, thereby breaking down the thrombus while sparing systemic fibrinogen.

The dose of Metalyse is individualized by the prescribing clinician, typically based on the patient’s body weight and the clinical protocol for STEMI. Exact dosing regimens are established by the treating physician and should follow local guidelines and product labeling.

Tenecteplase is classified as pregnancy category unknown; limited data exist on its use during pregnancy or lactation. Because it can cross the placenta and affect fetal clotting, it should be used only if the potential benefit justifies the potential risk to the fetus. Breastfeeding considerations follow the same precautionary principle.

To order Metalyse, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain handling if required) and the necessary import documentation.

Both Metalyse (tenecteplase) and alteplase are fibrinolytic agents, but tenecteplase has a longer plasma half‑life and can be given as a single intravenous bolus, whereas alteplase requires an initial bolus followed by an infusion. Tenecteplase also shows higher fibrin specificity, which may reduce systemic bleeding risk in some patients.

Metalyse is supplied as a lyophilized powder for reconstitution. It must be stored refrigerated at 2‑8 °C, protected from light, and must never be frozen or shaken. Once reconstituted, the solution should be used immediately or stored according to the manufacturer’s instructions, typically for a limited period under controlled conditions.

Metalyse is administered intravenously as a single bolus injection. The powder is reconstituted with the appropriate diluent to form a solution, which is then injected directly into a peripheral or central vein over a short period, as directed by the treating physician.

The most serious risks include intracranial hemorrhage, severe systemic bleeding, allergic reactions such as anaphylaxis, myocardial rupture, and disseminated intravascular coagulation. Clinicians should monitor patients closely for signs of bleeding, neurological changes, and hemodynamic instability during and after administration.

Metalyse is contraindicated in patients with active internal bleeding, recent intracranial hemorrhage, uncontrolled hypertension, known hypersensitivity to tenecteplase or any component of the formulation, and in those who have received another thrombolytic agent within the preceding 24 hours.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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