Product image of Novastan (Argatroban Monohydrate) supplied by GNH India

Novastan

Active Ingredient:
Argatroban Monohydrate
Origin:
EU

Novastan (Argatroban Monohydrate)

Argatroban, the active ingredient in Novastan, is a direct thrombin inhibitor presented as an injectable solution for intravenous use. It provides anticoagulation for patients with heparin‑induced thrombocytopenia, during percutaneous coronary interventions, and in cardiac surgery when rapid offset of anticoagulation is required.

GNH India supplies Novastan as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals worldwide.

Manufacturer / TM Owner

Ethypharm

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Indications & Clinical Uses

Novastan is a direct thrombin inhibitor used in clinical situations where precise anticoagulation control is needed.

  • Heparin‑induced thrombocytopenia (HIT): provides anticoagulation in patients who have developed HIT, reducing the risk of thrombotic complications.
  • Percutaneous coronary intervention (PCI): prevents thrombosis during and after PCI procedures, helping maintain vessel patency.
  • Cardiac surgery requiring rapid offset: administered to achieve anticoagulation with a quick reversal when surgery ends.

How It Works

  • Argatroban binds reversibly to the active site of thrombin (factor IIa), directly blocking its ability to convert fibrinogen into fibrin. By inhibiting thrombin, the drug interrupts the final step of the coagulation cascade, producing rapid anticoagulation without affecting upstream clotting factors.

Side Effects

Adverse reactions may vary in frequency and severity.

Common Side Effects

  • Bleeding at the infusion site
  • Minor gastrointestinal bleeding
  • Thrombocytopenia
  • Anemia
  • Elevated liver enzymes
  • Hypotension during infusion

Serious or Rare Side Effects

  • Severe or uncontrolled bleeding
  • Anaphylactic reaction
  • Hepatic failure
  • Disseminated intravascular coagulation (DIC)
  • Acute hemolysis
  • Life‑threatening thrombosis despite therapy

Precautions & Warnings

When using Argatroban, clinicians should consider several safety measures.

  • Renal impairment: monitor coagulation parameters closely.
  • Hepatic impairment: dose adjustment may be required due to hepatic metabolism.
  • Bleeding risk: assess patient history and current bleeding status before initiation.
  • Concurrent anticoagulants: avoid unless specifically directed by a physician.
  • Pregnancy and lactation: use only if the potential benefit justifies the potential risk.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze.

Avoid Interactions

Argatroban may interact with other agents that affect hemostasis.

Major Interactions (Avoid)

  • Other direct thrombin inhibitors: additive anticoagulant effect.
  • Potent CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase Argatroban plasma concentrations.
  • Fibrinolytic agents (e.g., alteplase): heightened risk of severe bleeding.

Moderate Interactions (Monitor Closely)

  • Warfarin: may increase INR and bleeding tendency.
  • Antiplatelet drugs (aspirin, clopidogrel): increased bleeding risk.
  • Non‑steroidal anti‑inflammatory drugs (NSAIDs): potential for gastrointestinal bleeding.

Frequently Asked Questions

Novastan contains Argatroban, a direct thrombin inhibitor used to provide anticoagulation in patients with heparin‑induced thrombocytopenia, during percutaneous coronary interventions, and in cardiac surgery when a rapid offset of anticoagulation is required.

Argatroban binds reversibly to thrombin’s active site, directly blocking the conversion of fibrinogen to fibrin. This inhibition stops the final step of the clotting cascade, producing rapid and controllable anticoagulation without affecting upstream clotting factors.

The dosing regimen for Novastan is individualized and set by the prescribing clinician based on the patient’s clinical condition, weight, renal and hepatic function, and laboratory monitoring of anticoagulation parameters.

Safety data for Argatroban in pregnancy and lactation are limited. It should be used only if the potential maternal benefit justifies any potential risk to the fetus or infant, and the decision must be made by the treating physician.

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

Compared with heparin, Argatroban does not bind plasma proteins and has a predictable anticoagulant effect, making it useful in heparin‑induced thrombocytopenia. Unlike some oral anticoagulants, it is administered intravenously and offers rapid onset and offset, which is advantageous during procedures requiring tight anticoagulation control.

Novastan should be stored at 2‑8 °C, protected from light, and kept in its original packaging. It must not be frozen or shaken vigorously. Before use, allow the product to reach room temperature if required by the manufacturer’s reconstitution instructions.

Novastan is given by intravenous infusion. The infusion rate and duration are determined by the prescriber and are adjusted according to laboratory monitoring of anticoagulation (e.g., activated clotting time or aPTT) to achieve the desired therapeutic range.

The most serious risks include severe or uncontrolled bleeding, anaphylactic reactions, hepatic dysfunction, and rare events such as disseminated intravascular coagulation. Patients should be closely monitored for signs of bleeding and liver enzyme changes during therapy.

Novastan is contraindicated in patients with known hypersensitivity to Argatroban or any component of the formulation, in those with active major bleeding, and in individuals for whom alternative anticoagulation strategies are more appropriate based on clinical judgment.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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