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 for intravenous use. It replaces deficient factor IX to restore normal clotting in patients with hemophilia B or other factor IX deficiencies.\n\nGNH India supplies Immunine as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres and pharmacies worldwide.

Manufacturer / TM Owner

Baxalta Innovations Gmbh

1
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Indications & Clinical Uses

  • Immunine is a recombinant coagulation factor used to manage bleeding disorders related to factor IX deficiency.\n\nHemophilia B: provides replacement of missing factor IX to achieve hemostasis and reduce bleeding episodes.\nFactor IX deficiency: restores adequate clotting activity to prevent spontaneous hemorrhage.\nPeri‑operative management: ensures sufficient factor IX levels for safe surgical or invasive procedures in affected patients.

How It Works

  • Human Coagulation Factor IX is a key component of the intrinsic pathway of the coagulation cascade. When administered intravenously, it binds to activated factor VIII on phospholipid surfaces, forming the tenase complex that activates factor X to Xa. This accelerates thrombin generation, leading to fibrin clot formation and restoration of normal hemostasis in individuals lacking functional factor IX.

Side Effects

  • Immunine may be associated with a range of adverse reactions following intravenous infusion.\n\nCommon Side Effects:\n- Infusion‑related reactions such as fever, chills, or flushing\n- Headache or mild dizziness\n- Nausea or abdominal discomfort\n- Arthralgia or joint pain\n\nSerious or Rare Side Effects:\n- Anaphylactic or severe allergic reactions\n- Development of neutralising antibodies (inhibitors) against factor IX\n- Thrombotic events including deep‑vein thrombosis\n- Hemolysis or renal impairment

Precautions & Warnings

  • Prior to initiating Immunine therapy, clinicians should consider several safety measures.\n\nMonitor for inhibitor development: perform periodic antibody testing to detect neutralising antibodies.\nAssess bleeding risk: evaluate patient history and current anticoagulant use before infusion.\nUse aseptic technique: prepare and administer the product under sterile conditions.\nAvoid in patients with known hypersensitivity: contraindicated for individuals with documented allergy to factor IX products.\nStore at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

  • Immunine can interact with other medications that affect coagulation or immune response.\n\nMajor Interactions (Avoid):\n- Anticoagulants (e.g., warfarin, heparin): may reduce the efficacy of factor IX replacement.\n- Immune tolerance induction agents: may increase the risk of inhibitor formation.\n\nModerate Interactions (Monitor Closely):\n- Aspirin or NSAIDs: may enhance bleeding tendency despite factor IX supplementation.\n- Antifibrinolytics (e.g., tranexamic acid): may increase risk of thrombosis when combined with factor IX.\n- Vaccines: monitor for heightened immune response or inhibitor development.

Frequently Asked Questions

Immunine is a prescription‑only biologic that provides human coagulation factor IX to patients with hemophilia B or other factor IX deficiencies. By replacing the missing clotting protein, it helps control and prevent bleeding episodes and supports safe surgical or invasive procedures.

Human Coagulation Factor IX participates in the intrinsic pathway of blood coagulation. When infused, it combines with activated factor VIII to form the tenase complex, which converts factor X to Xa, leading to thrombin generation and fibrin clot formation, thereby restoring normal hemostasis.

The dosage of Immunine is individualized. A qualified prescriber determines the amount and frequency based on the patient’s factor IX activity level, severity of bleeding, body weight, and clinical situation. Dosing instructions are provided on the prescription label.

Safety data for Immunine in pregnancy and lactation are limited. The decision to use the product should be based on a risk‑benefit assessment by the treating physician, considering the potential need for clotting factor replacement in the mother and the lack of definitive fetal safety information.

To request 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) and necessary import documentation.

Immunine is a recombinant human factor IX concentrate, offering high purity and low risk of viral transmission compared with plasma‑derived products. Compared with extended‑half‑life factor IX molecules, Immunine has a standard half‑life, requiring more frequent dosing but providing a well‑established safety profile.

Immunine must be stored refrigerated at 2‑8 °C. Keep the vial in its original packaging, protect it from light, and avoid freezing or shaking. If temperature excursions occur, discard the product according to the supplier’s guidelines.

Immunine is given by intravenous infusion. The healthcare professional prepares the sterile solution according to aseptic technique, selects an appropriate infusion rate, and monitors the patient for any adverse reactions during and after the administration.

The most serious risks include the development of neutralising antibodies (inhibitors) that reduce efficacy, severe allergic reactions such as anaphylaxis, and rare thrombotic events. Patients should be monitored closely for signs of these complications, especially after the first few infusions.

Immunine is contraindicated in individuals with known hypersensitivity to human factor IX products or any of the excipients in the formulation. Patients with a history of severe allergic reactions to clotting factor concentrates should avoid its use.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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