Product image of Octanine (Human Coagulation Factor Ix) supplied by GNH India

Octanine

Active Ingredient:
Human Coagulation Factor Ix
Origin:
EU

Octanine (Human Coagulation Factor Ix)

Human Coagulation Factor IX, the active ingredient in Octanine, is a coagulation factor replacement therapy presented as an intravenous solution for intravenous use. It treats hemophilia B and is used in patients with factor IX deficiency. GNH India supplies Octanine as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals worldwide.

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

Manufacturer / TM Owner

Octapharma Benelux S.A.

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Indications & Clinical Uses

Octanine is used in the management of bleeding disorders related to factor IX deficiency. It is indicated for:

  • Hemophilia B: Provides replacement of missing clotting factor to control and prevent bleeding episodes.
  • Perioperative management: Supplies factor IX to maintain hemostasis during and after surgery.
  • Trauma‑induced bleeding: Restores factor IX levels to aid clot formation in acute bleeding situations.

How It Works

  • Octanine contains recombinant human coagulation factor IX, which binds to activated factor X on platelet surfaces, forming the intrinsic tenase complex. This complex catalyzes the conversion of prothrombin to thrombin, leading to fibrin clot formation and restoration of normal hemostasis in individuals lacking functional factor IX.

Side Effects

Octanine may cause a range of adverse reactions. Common Side Effects:

  • Headache
  • Fever
  • Nausea
  • Mild infusion‑site redness
  • Transient elevated liver enzymes
  • Fatigue

Serious or Rare Side Effects

  • Development of inhibitory antibodies against factor IX
  • Anaphylactic or severe hypersensitivity reactions
  • Thromboembolic events such as deep‑vein thrombosis
  • Severe hemolysis
  • Renal impairment
  • Disseminated intravascular coagulation (DIC)

Precautions & Warnings

When using Octanine, consider the following precautions:

  • Monitor factor IX activity levels: Adjust dosing based on laboratory results.
  • Assess for inhibitors: Test for anti‑factor IX antibodies before and during therapy.
  • Evaluate bleeding risk: Use caution in patients with a history of thrombosis.
  • Review concomitant anticoagulants: Adjust therapy to avoid excessive clotting or bleeding.
  • Pregnancy and lactation: Use only if clearly needed; weigh maternal benefits against potential fetal risk.
  • Store at 2‑8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Octanine can interact with several medicines. Major Interactions (Avoid):

  • Activated protein C concentrates: May reduce efficacy of factor IX.
  • High‑dose aspirin or other antiplatelet agents: Increases bleeding risk.
  • Warfarin: May potentiate anticoagulant effect and complicate monitoring.

Moderate Interactions (Monitor Closely)

  • Non‑steroidal anti‑inflammatory drugs (NSAIDs): May modestly increase bleeding tendency.
  • Heparin: Requires careful coagulation monitoring.
  • Antibiotics such as quinolones: Potential for altered plasma protein binding.

Frequently Asked Questions

Octanine is a recombinant human coagulation factor IX product used to replace deficient factor IX in patients with hemophilia B, to manage bleeding episodes, support surgical procedures, and treat acute trauma‑related bleeding where factor IX levels are low.

The factor IX in Octanine binds to activated factor X on platelet surfaces, forming the intrinsic tenase complex that converts prothrombin to thrombin, leading to fibrin clot formation and restoration of normal hemostasis in individuals lacking functional factor IX.

Dosing of Octanine is individualized; the prescribing clinician determines the amount and frequency based on the patient’s factor IX activity level, severity of bleeding, body weight, and clinical response.

Octanine should be used during pregnancy or lactation only if clearly needed. Clinicians weigh the potential benefits for the mother against any possible risks to the fetus or infant, as safety data are limited.

To order Octanine, submit an enquiry on the product page at gnhindia.com with 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 if required) and import documentation.

Octanine is a recombinant factor IX concentrate similar in efficacy to other licensed factor IX products. Differences may include manufacturing source, specific activity, stability profile, and approved indications, which clinicians consider when selecting therapy.

Octanine must be stored at 2‑8 °C, protected from light, and kept in its original packaging. Do not freeze or shake the vial; allow the solution to reach room temperature before intravenous administration if required.

Octanine is supplied as an intravenous solution and is administered by slow IV infusion under aseptic conditions, typically in a clinical setting such as a hospital or infusion centre, following the prescriber’s dosing instructions.

Serious risks include the development of inhibitory antibodies against factor IX, severe hypersensitivity or anaphylactic reactions, and rare thrombotic events such as deep‑vein thrombosis or disseminated intravascular coagulation.

Octanine is contraindicated in patients with known hypersensitivity to any component of the product, and it should be used with caution in individuals with a history of inhibitors, severe thrombosis, or uncontrolled hypertension.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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