Product image of Octaplex (Human Coagulation Factor Ix, Protein C, Human Coagulation Factor Vii, Protein S, Human Coagulation F) supplied by GNH India

Octaplex

Active Ingredient:
Human Coagulation Factor Ix, Protein C, Human Coagulation Factor Vii, Protein S, Human Coagulation F
Origin:
EU

Octaplex (Human Coagulation Factor Ix, Protein C, Human Coagulation Factor Vii, Protein S, Human Coagulation F)

Human Coagulation Factor IX (recombinant), the active ingredient in Octaplex, is a coagulation factor replacement therapy presented as a sterile solution for intravenous use. It is used to manage bleeding episodes and peri‑operative hemostasis in patients with hemophilia B and related factor deficiencies. GNH India supplies Octaplex as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals worldwide.

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

Manufacturer / TM Owner

Octapharma Ab

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Indications & Clinical Uses

Octaplex is a recombinant coagulation factor that acts within the intrinsic pathway of the clotting cascade to correct specific factor deficiencies.

  • Hemophilia B: provides temporary replacement of factor IX to control and prevent bleeding.
  • Acquired factor IX deficiency: supplies the missing protein to restore normal clotting function.
  • Peri‑operative management: ensures adequate hemostasis during surgery for patients with factor IX deficiency.

How It Works

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

Side Effects

Adverse reactions to Octaplex are generally related to its protein nature and the intravenous route of administration.

Common Side Effects

  • Fever
  • Headache
  • Nausea
  • Mild infusion‑site erythema
  • Transient increase of ALT/AST

Serious or Rare Side Effects

  • Anaphylactic reaction
  • Development of inhibitors (neutralising antibodies) to factor IX
  • Thromboembolic events
  • Severe hypersensitivity including serum sickness
  • Disseminated intravascular coagulation (DIA ).

Precautions & Warnings

Octaplex should be used only under the supervision of a qualified healthcare professional familiar with coagulation disorders.

  • Dosing individualisation: adjust dose based on patient’s factor IX activity levels and clinical response.
  • Monitoring: regularly assess factor IX activity and watch for inhibitor development.
  • Contra‑indications: avoid in patients with known hypersensitivity to any component of the product.
  • Pregnancy and lactation: use only if clearly needed; benefits must outweigh risks.
  • Storage at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Octaplex may interact with other agents that affect hemostasis or immune response.

Major Interactions (Avoid)

  • Antifibrinolytics (e.g., tranexamic acid) combined with high‑dose factor IX may increase thrombosis risk.
  • Immune‑modulating therapies that could accelerate inhibitor formation.

Moderate Interactions (Monitor Closely)

  • Concomitant use of other clotting factor concentrates.
  • Concurrent anticoagulants (e.g., warfarin, direct oral anticoagulants) requiring careful monitoring of coagulation parameters.
  • Vaccines administered shortly before or after infusion may alter immune response.
  • Antibiotics such as beta‑lactams that can cause hypersensitivity reactions.
  • Non‑steroidal anti‑inflammatory drugs (NSAIDs) that may increase bleeding tendency if factor levels are sub‑therapeutic.

Frequently Asked Questions

Octaplex is a recombinant human factor IX concentrate used to replace missing or deficient factor IX in patients with hemophilia B, acquired factor IX deficiency, or during surgery to provide adequate hemostasis.

The recombinant factor IX in Octaplex binds to activated factor X on platelet surfaces, forming the intrinsic tenase complex that accelerates conversion of prothrombin to thrombin, leading to fibrin clot formation and restored normal blood clotting.

The dose of Octaplex is individualized; a qualified prescriber determines the amount and frequency based on the patient’s factor IX activity level, weight, severity of bleeding and clinical situation.

Octaplex may be used in pregnancy or lactation only when clearly needed. The prescriber must weigh potential benefits against risks, as limited data are available on fetal and infant exposure.

To order Octaplex, 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.

Octaplex is a recombinant, plasma‑free factor IX concentrate, offering a high purity profile and reduced risk of pathogen transmission compared with plasma‑derived products. Its pharmacokinetic profile is comparable to other recombinant factor IX products, but specific dosing and half‑life may differ.

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

Octaplex is given by intravenous infusion. The rate and volume are determined by the prescriber, and the infusion set should be compatible with protein solutions to avoid adsorption.

Serious risks include anaphylactic reactions, development of neutralising inhibitors to factor IX, thromboembolic events and disseminated intravascular coagulation. Immediate medical attention is required if any of these occur.

Octaplex is contraindicated in individuals with known hypersensitivity to recombinant factor IX or any excipient in the formulation. It should also be avoided in patients with a history of severe inhibitor development unless under specialist supervision.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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