Product image of Octanate (Human Coagulation Factor Viii) supplied by GNH India

Octanate

Active Ingredient:
Human Coagulation Factor Viii
Origin:
EU

Octanate (Human Coagulation Factor Viii)

Human Coagulation Factor VIII, the active ingredient in Octanate, is a blood coagulation factor presented as a sterile injectable solution for intravenous use. It replaces deficient factor VIII in patients with hemophilia A and related bleeding disorders.
GNH India supplies Octanate as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals worldwide.

Manufacturer / TM Owner

Octapharma Ab

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Indications & Clinical Uses

Octanate is a factor VIII concentrate used in the management of bleeding disorders that involve the intrinsic coagulation pathway.

  • Hemophilia A (severe): provides replacement of deficient factor VIII to prevent or control spontaneous and traumatic bleeding.
  • Hemophilia A (moderate to mild): raises factor levels to reduce bleeding frequency and severity.
  • Acquired hemophilia A: supplies exogenous factor VIII to counteract auto‑antibody mediated deficiency.
  • Peri‑operative management: ensures adequate hemostasis during surgical procedures in patients with factor VIII deficiency.

How It Works

  • Octanate supplies functional human factor VIII, a cofactor that binds activated factor IX on phospholipid surfaces, accelerating the conversion of factor X to Xa within the intrinsic tenase complex. This restores the cascade that generates thrombin, leading to fibrin clot formation and hemostasis.

Side Effects

Octanate may be associated with adverse reactions following infusion.

Common Side Effects

  • Infusion‑related reactions: fever, chills, headache, nausea, arthralgia, fatigue.
  • Local site discomfort at the injection site.
  • Transient elevations in liver enzymes.

Serious or Rare Side Effects

  • Development of neutralizing inhibitors (antibodies) against factor VIII.
  • Anaphylaxis or severe hypersensitivity reactions.
  • Thrombotic events, including deep vein thrombosis.
  • Transmission of viral pathogens (theoretical risk).

Precautions & Warnings

Octanate requires careful monitoring to ensure safety and efficacy.

  • Allergic reactions: observe patients for signs of hypersensitivity during and after infusion.
  • Inhibitor development: test for neutralizing antibodies regularly, especially in previously untreated patients.
  • Bleeding risk: adjust dosing based on clinical response and factor VIII activity levels.
  • Surgical procedures: confirm adequate factor levels before any invasive intervention.
  • Pregnancy and lactation: use only if the potential benefit justifies the potential risk to the fetus or infant.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Octanate may interact with other hemostatic agents, affecting coagulation balance.

Major Interactions (Avoid)

  • Activated prothrombin complex concentrates (aPCC): increased risk of thrombosis when combined with factor VIII.
  • High‑dose antifibrinolytics (e.g., tranexamic acid) in patients with a history of thromboembolic disease.

Moderate Interactions (Monitor Closely)

  • Other factor concentrates (e.g., factor IX): monitor for additive clotting effects.
  • Immunosuppressive therapies: may influence inhibitor development.
  • Vaccines administered concurrently: observe for enhanced immune response.

Frequently Asked Questions

Octanate is a human coagulation factor VIII concentrate used to replace deficient factor VIII in patients with hemophilia A, acquired hemophilia A, and for peri‑operative bleeding management. It helps achieve hemostasis by restoring the intrinsic pathway of the clotting cascade.

The factor VIII in Octanate acts as a cofactor for activated factor IX, forming the intrinsic tenase complex that accelerates conversion of factor X to Xa. This step generates thrombin, leading to fibrin clot formation and cessation of bleeding.

The dose of Octanate is individualized and determined by the prescribing clinician based on the patient’s weight, severity of factor VIII deficiency, type of bleed, and target factor activity levels. Exact dosing regimens are not publicly disclosed.

Octanate may be used in pregnancy or lactation only when the potential benefit to the mother outweighs any potential risk to the fetus or infant. Treatment decisions should be made by a qualified healthcare professional familiar with the patient’s condition.

To request Octanate, 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 needed) and import documentation.

Octanate is a plasma‑derived factor VIII concentrate, whereas many alternatives are recombinant. Both provide functional factor VIII, but plasma‑derived products contain a broader spectrum of von Willebrand factor, which may influence inhibitor development rates. Choice depends on clinical considerations, availability, and patient-specific factors.

Octanate must be stored refrigerated at 2‑8 °C, protected from light, and must not be frozen or shaken. Prior to use, allow the product to reach room temperature if required, and inspect for any discoloration or particulate matter before infusion.

Octanate is administered by intravenous infusion under the supervision of a qualified healthcare professional. The infusion rate and volume are determined by the prescribing clinician, and patients are monitored for any adverse reactions during and after the infusion.

Serious risks include the development of neutralizing inhibitors against factor VIII, severe allergic or anaphylactic reactions, and rare thrombotic events. Patients should be monitored closely for signs of these complications, especially during the initial treatment phases.

Octanate is contraindicated in individuals with known hypersensitivity to any component of the product, including human plasma proteins. Patients with active, uncontrolled thrombotic disorders should avoid use unless specifically directed by a physician.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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