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 a sterile solution for intravenous use. It replaces deficient factor IX in patients with hemophilia B, helping to restore normal clotting function.

GNH India supplies Octanine as a licensed, GDP‑compliant international pharmaceutical supplier, providing the product to hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide through regulated supply chains, ensuring quality and traceability.

Manufacturer / TM Owner

Octapharma (Ip) Sprl

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Indications & Clinical Uses

Octanine is a coagulation factor replacement used in the management of hemophilia B.

  • Hemophilia B: provides factor IX to support clot formation and reduce bleeding episodes.
  • Perioperative management in hemophilia B patients: maintains hemostasis during surgical procedures.
  • Trauma‑related bleeding in hemophilia B: supplies factor IX to control acute bleeding events.

How It Works

  • Octanine supplies recombinant human factor IX that replaces the deficient endogenous protein. The administered factor IX binds to activated factor X on platelet surfaces, restoring the intrinsic pathway of the coagulation cascade and enabling conversion of prothrombin to thrombin, which leads to fibrin clot formation and normal hemostasis in patients with hemophilia B.

Side Effects

Octanine may be associated with several adverse reactions.

Common Side Effects

  • Injection site pain
  • Fever
  • Headache
  • Nausea

Serious or Rare Side Effects

  • Development of inhibitors (neutralizing antibodies)
  • Anaphylaxis
  • Thrombotic events

Precautions & Warnings

Before using Octanine, consider the following precautions.

  • Monitor inhibitor development: test for antibodies regularly.
  • Assess for allergic reactions: observe patient after infusion.
  • Adjust dose in renal impairment: consider renal function when dosing.
  • Avoid use in patients with known hypersensitivity to factor IX products.
  • Pregnancy considerations: weigh benefits versus potential risks.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Octanine can interact with other medicines; review the following.

Major Interactions (Avoid)

  • Concurrent use of anticoagulants (e.g., warfarin, direct oral anticoagulants): may reduce efficacy of factor IX.
  • High‑dose aspirin or NSAIDs: increase bleeding risk despite replacement therapy.

Moderate Interactions (Monitor Closely)

  • Live attenuated vaccines: monitor immune response after administration.
  • Other plasma‑derived products: risk of additive inhibitor formation.
  • Immunosuppressive agents: may affect inhibitor development.

Frequently Asked Questions

Octanine is a sterile injectable containing human coagulation factor IX, used to replace deficient factor IX in patients with hemophilia B and to manage bleeding episodes, surgical procedures, and trauma‑related bleeding in this population.

The recombinant factor IX supplied by Octanine binds to activated factor X on platelet surfaces, restoring the intrinsic pathway of the coagulation cascade. This enables the conversion of prothrombin to thrombin, leading to fibrin clot formation and normal hemostasis in individuals lacking functional factor IX.

The dose of Octanine is individualized by the prescribing clinician based on the patient’s weight, severity of deficiency, and the clinical situation (e.g., prophylaxis, on‑demand treatment, or surgery). The prescriber determines the exact units or volume to be administered intravenously.

Use of Octanine during pregnancy or lactation should be considered only when the potential benefit to the mother outweighs any possible risk to the fetus or infant. Clinicians typically evaluate each case, and limited data are available; therefore, it is used under specialist supervision.

To order Octanine, 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 logistics if needed) and necessary import documentation.

Octanine provides recombinant human factor IX similar in efficacy to other licensed factor IX concentrates. Compared with plasma‑derived products, recombinant forms have a lower risk of viral transmission and may have different immunogenicity profiles. Choice of product depends on clinical factors, availability, and physician preference.

Octanine must be stored at 2‑8 °C (refrigerated). Keep the vials in the original packaging, protect them from light, and avoid freezing or shaking. If temperature excursions occur, discard the product according to the manufacturer’s guidelines.

Octanine is given by intravenous infusion. The healthcare professional prepares the prescribed dose under aseptic conditions and administers it slowly, typically over several minutes, while monitoring the patient for any immediate adverse reactions. Dosing intervals are determined by the treating physician.

The most serious risks include the development of neutralizing antibodies (inhibitors) that reduce efficacy, severe allergic reactions such as anaphylaxis, and rare thrombotic events. Patients should be closely monitored for signs of inhibitor formation and hypersensitivity during and after infusion.

Octanine is contraindicated in individuals with known hypersensitivity to human factor IX or any component of the formulation. Patients with a history of severe inhibitor development or those who have experienced anaphylactic reactions to factor IX products should avoid its use unless under strict specialist supervision.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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