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 replaces deficient factor IX in patients with hemophilia B, helping to control bleeding episodes. GNH India supplies Octanine as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals and clinics worldwide.

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

Manufacturer / TM Owner

Octapharma (Ip) Sprl

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Indications & Clinical Uses

Octanine is used in the management of inherited bleeding disorders that involve factor IX deficiency.

  • Hemophilia B: Provides temporary replacement of factor IX to prevent or control bleeding.
  • Perioperative management: Supplies factor IX to maintain hemostasis during surgery for patients with hemophilia B.
  • Trauma‑related bleeding: Offers factor IX replacement to manage acute bleeding episodes in individuals with known factor IX deficiency.

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 accelerates the conversion of factor X to factor Xa, restoring the normal cascade of thrombin generation and fibrin clot formation that is deficient in hemophilia B patients.

Side Effects

Adverse reactions to Octanine may vary in frequency and severity.

Common Side Effects

  • Headache
  • Fever
  • Nausea
  • Injection site erythema
  • Mild hypotension
  • Fatigue

Serious or Rare Side Effects

  • Anaphylactic reaction
  • Development of inhibitors (neutralizing antibodies)
  • Thromboembolic events
  • Severe hypersensitivity including angioedema
  • Renal impairment
  • Hepatotoxicity

Precautions & Warnings

When using Octanine, clinicians should consider several safety measures.

  • Dosing adjustments: Tailor dose based on individual pharmacokinetic response and factor IX activity levels.
  • Inhibitor monitoring: Test periodically for development of factor IX inhibitors.
  • Surgical planning: Ensure adequate factor IX levels are achieved before invasive procedures.
  • Pregnancy and lactation: Evaluate risk‑benefit ratio carefully; limited data are available.
  • Storage: Store at 2‑8 °C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Octanine may interact with other agents that affect hemostasis.

Major Interactions (Avoid)

  • Antifibrinolytics such as tranexamic acid combined with high‑dose factor IX may increase thrombotic risk.
  • Concomitant use of pro‑coagulant agents (e.g., activated factor VII) can lead to excessive clot formation.

Moderate Interactions (Monitor Closely)

  • Immunosuppressive therapies may influence inhibitor development.
  • Certain antibiotics (e.g., beta‑lactams) have been reported to cause hypersensitivity when given with protein therapeutics.
  • Vaccines administered shortly before or after infusion may modestly raise the risk of allergic reactions.

Frequently Asked Questions

Octanine is a recombinant human coagulation factor IX product used to replace deficient factor IX in patients with hemophilia B and to manage bleeding episodes or surgical procedures that require adequate hemostasis.

The factor IX in Octanine binds to activated factor X on platelet surfaces, forming the intrinsic tenase complex that accelerates conversion of factor X to factor Xa, thereby restoring thrombin generation and enabling normal clot formation in individuals lacking functional factor IX.

The prescribed dose of Octanine is individualized by the treating physician based on the patient’s weight, severity of factor IX deficiency, bleeding severity, and target factor IX activity levels; exact regimens are not publicly standardized.

Safety data for Octanine in pregnancy and lactation are limited; clinicians should weigh potential benefits against risks and consider alternative management strategies, as factor IX products cross the placenta and may be present in breast milk.

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 handling) and necessary import documentation.

Octanine is a recombinant factor IX concentrate similar in efficacy to other licensed recombinant products, offering a purified intravenous formulation. Differences among products may include manufacturing processes, specific activity, stability profiles, and approved indications, which clinicians evaluate when selecting therapy.

Octanine should be stored at 2‑8 °C, protected from light, and must not be frozen or shaken. Before use, inspect the solution for particulate matter and ensure the vial is within its expiry date.

Octanine is given as an intravenous infusion, typically diluted in a compatible solution and administered slowly under clinical supervision, with dosing adjusted according to factor IX activity monitoring.

Serious risks include the development of neutralizing inhibitors against factor IX, severe allergic reactions such as anaphylaxis, and rare thromboembolic events, all of which require immediate medical attention.

Octanine is contraindicated in patients with known hypersensitivity to any component of the product, including the recombinant protein or excipients, and in individuals who have previously developed severe allergic reactions to factor IX concentrates.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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