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 an injectable solution for intravenous use. It replaces deficient factor IX to treat patients with hemophilia B and acquired 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.

Manufacturer / TM Owner

Baxalta Innovations Gmbh

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Indications & Clinical Uses

  • Immunine is used within the coagulation factor replacement therapy pathway to manage bleeding disorders.
  • Hemophilia B: restores normal clotting and reduces bleeding episodes.
  • Acquired factor IX deficiency: provides the missing factor to re‑establish hemostasis.
  • Peri‑operative management in factor IX‑deficient patients: ensures adequate clot formation during surgery.

How It Works

  • Human Coagulation Factor IX acts as a direct replacement for the missing or deficient endogenous factor IX. After intravenous infusion, it integrates into the intrinsic pathway of the coagulation cascade, forming the tenase complex that activates factor X, leading to thrombin generation and stable fibrin clot formation.

Side Effects

Immunine may cause adverse reactions following infusion.

Common Side Effects

  • Infusion‑related reactions (fever, chills, flushing)
  • Headache
  • Nausea
  • Arthralgia
  • Mild hypertension
  • Transient increase in liver enzymes

Serious or Rare Side Effects

  • Anaphylaxis or severe allergic reaction
  • Development of neutralizing inhibitors (antibodies) to factor IX
  • Thromboembolic events (deep vein thrombosis, pulmonary embolism)
  • Severe hypertension or hypertensive crisis
  • Renal impairment or acute kidney injury
  • Disseminated intravascular coagulation (rare)

Precautions & Warnings

  • Before using Immunine, consider the following precautions.
  • Monitor for inhibitor development: test for anti‑factor IX antibodies periodically.
  • Assess allergy history: avoid in patients with known hypersensitivity to factor IX products.
  • Use cautiously in cardiovascular disease: monitor blood pressure and signs of thrombosis.
  • Avoid concurrent use with other pro‑coagulant agents unless medically indicated.
  • Ensure dosing is individualized by a qualified haemophilia specialist.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Immunine may interact with other medicines that affect coagulation.

Major Interactions (Avoid)

  • Concomitant use of anticoagulants such as warfarin may diminish therapeutic effect and increase bleeding risk.
  • Simultaneous administration of activated prothrombin complex concentrates can raise the risk of thrombotic complications.

Moderate Interactions (Monitor Closely)

  • Aspirin or NSAIDs may exacerbate bleeding tendencies; monitor haemostasis.
  • Other clotting factor concentrates may alter dosing requirements; adjust under specialist guidance.
  • Immunosuppressive agents could influence inhibitor formation; observe antibody titres.

Frequently Asked Questions

Immunine is a prescription biologic that provides human coagulation factor IX to patients with hemophilia B or acquired factor IX deficiency, helping to restore normal clotting and control bleeding episodes.

The factor IX in Immunine replaces the missing or deficient protein in the intrinsic coagulation pathway. It participates in the tenase complex, activating factor X, which leads to thrombin generation and formation of a stable fibrin clot.

The dose of Immunine is individualized and determined by the prescribing haemophilia specialist based on the patient’s factor IX level, weight, severity of bleeding, and clinical situation.

Safety data for Immunine in pregnancy and lactation are limited. The decision to use it should be made by the treating physician after weighing potential benefits against any unknown risks to the mother and infant.

To order Immunine, submit an enquiry on the product page at gnhindia.com with 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.

Immunine is a recombinant or plasma‑derived factor IX concentrate similar in efficacy to other licensed factor IX therapies. Differences may exist in manufacturing source, stability profile, and regulatory approvals, but clinical outcomes are comparable when dosed appropriately.

Immunine must be stored refrigerated at 2‑8 °C, protected from light, and should never be frozen or shaken. Keep the product in its original packaging until use to maintain potency.

Immunine is given by intravenous infusion under the supervision of a qualified healthcare professional. The infusion rate and volume are adjusted according to the patient’s condition and the prescribing information.

Serious risks include the development of neutralizing inhibitors against factor IX, severe allergic reactions such as anaphylaxis, and rare thromboembolic events. Patients should be monitored closely for these complications.

Immunine should not be used in individuals with a known hypersensitivity to human factor IX products or any of the excipients. It is also contraindicated in patients with active thrombotic disorders unless specifically directed by a specialist.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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