Europe — EMA
Novastan (Argatroban Monohydrate)
GNH USA supplies Novastan (Argatroban), a direct thrombin inhibitor for anticoagulation in heparin‑induced thrombocytopenia, PCI and cardiac surgery.
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What is 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 USA supplies Novastan as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals worldwide.
What is Argatroban Monohydrate used for?
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.
What are the side effects of Argatroban Monohydrate?
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
What precautions apply to Argatroban Monohydrate?
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.
What does Argatroban Monohydrate interact with?
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.



