Europe — EMA
Novastan (Argatroban Monohydrate)
GNH USA supplies Novastan (Argatroban), a direct thrombin inhibitor for heparin‑induced thrombocytopenia and anticoagulation during PCI.
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What is Argatroban Monohydrate?
Argatroban, the active ingredient in Novastan, is a direct thrombin inhibitor presented as an injection solution for intravenous use. It is used to prevent and treat thrombosis in patients with heparin‑induced thrombocytopenia and to provide anticoagulation during percutaneous coronary intervention.
GNH USA supplies Novastan as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide.
What is Argatroban Monohydrate used for?
Novastan is a direct thrombin inhibitor used in clinical settings where anticoagulation is required without heparin.
Heparin‑induced thrombocytopenia (HIT): provides anticoagulation to prevent and treat thrombosis in patients who have developed HIT. Percutaneous coronary intervention (PCI): maintains anticoagulation during the procedure to reduce clot formation. Patients contraindicated for heparin: offers an alternative anticoagulant when heparin use is not advisable.
What are the side effects of Argatroban Monohydrate?
Common Side Effects: - Bleeding at the injection site - Mild hypotension - Nausea - Transient fever
Serious or Rare Side Effects: - Severe hemorrhage - Thrombocytopenia - Allergic reactions, including anaphylaxis - Elevated liver enzymes
What precautions apply to Argatroban Monohydrate?
When using Novastan, clinicians should consider the following precautions: - Hepatic impairment: use with caution and monitor coagulation parameters. - Bleeding risk: assess patient history and watch for signs of bleeding. - Concurrent anticoagulants: avoid combination unless medically indicated. - Pregnancy and lactation: safety not established; use only if benefit outweighs risk. - Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.
What does Argatroban Monohydrate interact with?
Novastan may interact with several drug classes, requiring careful management.
Major Interactions (Avoid): - Other anticoagulants (e.g., warfarin, direct oral anticoagulants): additive bleeding risk. - Antiplatelet agents (e.g., clopidogrel, aspirin): increase hemorrhage risk. - Potent CYP3A4 inhibitors (e.g., ketoconazole): may raise Argatroban plasma levels.
Moderate Interactions (Monitor Closely): - CYP3A4 inducers (e.g., rifampin): may reduce Argatroban efficacy. - Non‑steroidal anti‑inflammatory drugs (NSAIDs): may increase bleeding tendency. - Heparin: overlapping anticoagulant effect; monitor coagulation closely.



