Product image of Orgaran (Danaparoid Sodium) supplied by GNH India

Orgaran

Active Ingredient:
Danaparoid Sodium
Origin:
EU

Orgaran (Danaparoid Sodium)

Danaparoid Sodium, the active ingredient in Orgaran, is a heparinoid presented as an injectable solution for intravenous infusion use. It is employed for the prophylaxis and treatment of venous thromboembolism in patients with heparin‑induced thrombocytopenia and for preventing deep‑vein thrombosis when HIT is a concern.

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

Manufacturer / TM Owner

Viatris Healthcare Limited

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Indications & Clinical Uses

Orgaran is an anticoagulant that acts within the coagulation cascade to prevent clot formation in high‑risk settings.

  • Heparin‑induced thrombocytopenia (HIT): Provides safe prophylaxis and treatment of venous thromboembolism without cross‑reactivity to heparin antibodies.
  • Orthopedic surgery: Prevents deep‑vein thrombosis in patients where HIT risk precludes standard heparin use.
  • Vascular surgery: Reduces incidence of postoperative thrombotic events in HIT‑susceptible individuals.

How It Works

  • Danaparoid sodium exerts its anticoagulant effect by indirectly inhibiting factor Xa and, to a lesser extent, factor IXa through potentiation of antithrombin III activity. This reduces thrombin generation and limits fibrin clot formation, providing anticoagulation without significant interaction with platelet factor 4 antibodies.

Side Effects

Adverse reactions to Danaparoid sodium may range from mild to severe and should be monitored during therapy.

Common Side Effects

  • Minor bleeding at infusion site
  • Hematuria
  • Epistaxis
  • Gastrointestinal bleeding
  • Bruising or ecchymosis
  • Elevated liver enzymes

Serious or Rare Side Effects

  • Major hemorrhage (intracranial, gastrointestinal)
  • Thrombocytopenia unrelated to HIT
  • Hypersensitivity reactions including anaphylaxis
  • Disseminated intravascular coagulation (DIC)
  • Acute renal failure secondary to bleeding
  • Severe skin necrosis at infusion site

Precautions & Warnings

When using Orgaran, clinicians should assess patient‑specific risk factors and monitor laboratory parameters.

  • Renal impairment: Adjust dosing and monitor renal function closely.
  • Hepatic dysfunction: Observe liver enzymes and consider dose modification.
  • Concomitant anticoagulants: Evaluate cumulative bleeding risk.
  • Recent surgery or trauma: Delay infusion until hemostasis is secured.
  • Pregnancy and lactation: Use only if clearly indicated after risk‑benefit evaluation.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Danaparoid sodium can interact with several drug classes, influencing bleeding risk and anticoagulant effectiveness.

Major Interactions (Avoid)

  • Direct thrombin inhibitors (e.g., argatroban, dabigatran): combined use markedly increases bleeding risk.
  • Factor Xa inhibitors (e.g., rivaroxaban, apixaban): additive anticoagulant effect may lead to severe hemorrhage.

Moderate Interactions (Monitor Closely)

  • Antiplatelet agents (aspirin, clopidogrel): may enhance minor bleeding.
  • Non‑steroidal anti‑inflamatory NSAIDs: increase gastrointestinal bleeding potential.
  • Glycoprotein IIb/IIIa inhibitors: monitor platelet counts and bleeding signs.
  • Heparin products: cross‑reactivity risk requires careful laboratory monitoring.
  • Vitamin K antagonists (warfarin): overlapping anticoagulation necessitates INR surveillance.

Frequently Asked Questions

Orgaran is an injectable anticoagulant indicated for the prophylaxis and treatment of venous thromboembolism in patients who have heparin‑induced thrombocytopenia (HIT) and for preventing deep‑vein thrombosis in surgical settings where HIT is a concern.

Danaparoid sodium indirectly inhibits coagulation factor Xa and, to a lesser extent, factor IXa by enhancing antithrombin III activity. This reduces thrombin generation, limiting fibrin clot formation while avoiding significant interaction with platelet factor 4 antibodies.

The dosing regimen for Orgaran is individualized by the prescribing clinician based on the patient’s indication, weight, renal function and bleeding risk. Healthcare professionals determine the appropriate infusion rate and duration.

Safety data for Danaparoid sodium in pregnancy and lactation are limited. It should be used only when clearly needed after a careful risk‑benefit assessment by the treating physician.

To order Orgaran, 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 if required) and import documentation.

Orgaran (danaparoid sodium) offers anticoagulation without cross‑reactivity to heparin‑PF4 antibodies, unlike unfractionated heparin or low‑molecular‑weight heparins. Compared with argatroban, it has a longer half‑life and is primarily renally cleared, which may influence selection based on patient comorbidities.

Orgaran should be stored at 2‑8 °C, protected from light, and must not be frozen or shaken. Keep the vial in its original packaging until use to maintain stability.

Orgaran is supplied as an injectable solution for intravenous infusion. It is administered by slow IV push or infusion under aseptic conditions, following the dosing instructions provided by the prescribing clinician.

The most serious risks include major bleeding events such as intracranial or gastrointestinal hemorrhage, hypersensitivity reactions including anaphylaxis, and rare occurrences of disseminated intravascular coagulation. Patients should be monitored closely for any signs of bleeding or allergic response.

Orgaran is contraindicated in patients with known hypersensitivity to danaparoid sodium or any component of the formulation, and should be used with caution in individuals with active major bleeding, severe thrombocytopenia unrelated to HIT, or uncontrolled hypertension.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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