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

Immunine

Active Ingredient:
Human Coagulation Factor Ix
Origin:
EU

Immunine (Human Coagulation Factor Ix)

Human Coagulation Factor IX, the active ingredient in Immunine, is a coagulation factor presented as a sterile intravenous solution. It replaces deficient factor IX to correct the intrinsic pathway of the coagulation cascade, providing clotting support for individuals with hemophilia B (factor IX deficiency).

GNH India supplies Immunine as a licensed, GDP‑compliant international pharmaceutical supplier, serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide with reliable access to this essential biologic.

Manufacturer / TM Owner

Baxalta Innovations Gmbh

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Indications & Clinical Uses

  • Immunine is used to manage disorders of the intrinsic coagulation pathway, specifically hemophilia B.
  • Hemophilia B (Factor IX deficiency): Provides factor IX replacement to achieve hemostasis.
  • Surgical prophylaxis in hemophilia B patients: Maintains adequate clotting during operative procedures.
  • Bleeding episodes in hemophilia B: Controls acute hemorrhage.

How It Works

  • Immunine supplies exogenous human factor IX, which binds to activated factor X on phospholipid surfaces, restoring the intrinsic tenase complex. This re‑establishes the conversion of factor X to Xa, leading to thrombin generation and fibrin clot formation, thereby correcting the coagulation defect in patients lacking functional factor IX.

Side Effects

Common Side Effects

  • Infusion‑related reactions (e.g., flushing, chills)
  • Headache
  • Fever
  • Nausea
  • Arthralgia
  • Mild hypertension

Serious or Rare Side Effects

  • Development of inhibitory antibodies against factor IX
  • Anaphylactic or severe allergic reactions
  • Thromboembolic events
  • Transmission of viral pathogens
  • Renal dysfunction
  • Hemolysis

Precautions & Warnings

  • Immunine requires careful clinical monitoring and individualized dosing.
  • Dose adjustment: Tailor dosage based on factor IX activity levels and patient response.
  • Monitoring: Regularly assess for inhibitor development and coagulation parameters.
  • Allergy: Evaluate for hypersensitivity to plasma‑derived proteins before administration.
  • Pregnancy and lactation: Use only if the potential benefit justifies the potential risk; data are limited.
  • Concomitant anticoagulants: Use with caution and monitor bleeding risk.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Immunine may interact with other hemostatic agents and anticoagulants.

Major Interactions (Avoid)

  • Concurrent use of activated prothrombin complex concentrates: increased thrombosis risk.
  • High‑dose factor IX with antifibrinolytics: potential for excessive clot formation.
  • Live vaccines: may alter immune response.

Moderate Interactions (Monitor Closely)

  • Heparin: monitor anticoagulation parameters.
  • Antiplatelet agents: heightened bleeding risk.
  • Other clotting factor products: assess cumulative factor levels.

Frequently Asked Questions

Immunine is indicated for the treatment and prevention of bleeding in patients with hemophilia B, a genetic deficiency of coagulation factor IX. It provides the missing factor to restore normal clotting function during routine care, surgical procedures, or acute bleeding episodes.

Human Coagulation Factor IX supplied by Immunine replaces the deficient protein in hemophilia B patients. Once infused, it participates in the intrinsic tenase complex, activating factor X to Xa, which then leads to thrombin generation and fibrin clot formation, correcting the coagulation defect.

The dose of Immunine is individualized by the prescribing clinician based on the patient’s baseline factor IX activity, the severity of bleeding, body weight, and the clinical situation (e.g., prophylaxis versus acute treatment). No fixed dosing regimen is provided in public information.

Safety data for Immunine in pregnancy and lactation are limited. It should only be used when the potential benefit to the mother outweighs any possible risk to the fetus or infant, and the decision should be made by a qualified healthcare professional.

To order Immunine, 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 if needed), and import documentation.

Immunine belongs to the same therapeutic class as other factor IX concentrates, whether plasma‑derived or recombinant. All aim to restore factor IX activity, but differences may exist in manufacturing processes, viral inactivation methods, and immunogenicity profiles. Clinical choice depends on physician preference, patient history, and regulatory approvals.

Immunine must be stored at 2‑8 °C in a refrigerator, protected from light. It should not be frozen or shaken. Before use, inspect the vial for particulate matter or discoloration and allow the solution to reach room temperature if required by the administration protocol.

Immunine is given by intravenous infusion under the supervision of a qualified healthcare professional. The infusion rate and volume are determined by the prescribing clinician, who may adjust based on patient tolerance and factor IX activity levels measured during treatment.

The most serious risks include the development of inhibitory antibodies that neutralize factor IX activity, severe allergic or anaphylactic reactions, and rare thromboembolic events. Monitoring for these complications is essential, especially after repeated exposures.

Immunine 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 uncontrolled thrombosis should also avoid its use unless specifically advised by a specialist.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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