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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 / for intravenous use. It replaces deficient factor IX in patients with Hemophilia B, enabling normal clot formation.\n\nGNH India supplies Immunine as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals worldwide.

Manufacturer / TM Owner

Baxalta Innovations Gmbh

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Indications & Clinical Uses

  • Immunine is a recombinant coagulation factor used to manage disorders of the intrinsic clotting pathway, primarily Hemophilia B.\n\nHemophilia B: restores clotting ability by providing functional factor IX.\nPerioperative management in Hemophilia B: supplies adequate factor levels during surgery to prevent excessive bleeding.\nBleeding episodes in Hemophilia B: enables rapid hemostasis during spontaneous or trauma‑induced bleeds.

How It Works

  • Human Coagulation Factor IX replaces the missing or deficient endogenous factor IX in the intrinsic pathway of the coagulation cascade. By binding to activated factor VIII on phospholipid surfaces, it activates factor X to Xa, leading to thrombin generation and fibrin clot formation, thereby correcting the coagulation defect in Hemophilia B patients.

Side Effects

  • Immunine may be associated with adverse reactions following intravenous administration.\n\nCommon Side Effects:\n- Infusion‑related reactions such as chills, fever, or flushing.\n- Headache or mild nausea.\n- Arthralgia or joint discomfort.\n- Transient elevation of liver enzymes.\n\nSerious or Rare Side Effects:\n- Development of inhibitory antibodies against factor IX.\n- Anaphylactic or severe allergic reactions.\n- Thromboembolic events including deep vein thrombosis.\n- Potential transmission of viral pathogens despite purification processes.

Precautions & Warnings

  • When using Immunine, several precautions should be observed to ensure safety and efficacy.\n\nDose adjustment: tailor dosing based on individual factor IX activity levels and clinical response.\nMonitor for inhibitors: regularly test for anti‑factor IX antibodies during therapy.\nAvoid in patients with known hypersensitivity to human plasma proteins.\nUse with caution in individuals with cardiovascular disease or a history of thrombosis.\nStore at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

  • Immunine can interact with other agents that affect hemostasis or immune response.\n\nMajor Interactions (Avoid):\n- Concurrent use of other plasma‑derived factor IX products may increase inhibitor risk.\n- Administration with high‑dose immunoglobulins can reduce factor IX efficacy.\n\nModerate Interactions (Monitor Closely):\n- Anticoagulants such as warfarin or heparin may require closer coagulation monitoring.\n- Antifibrinolytic agents (e.g., tranexamic acid) may increase thrombotic risk when combined.\n- NSAIDs or aspirin can exacerbate bleeding if factor levels are insufficient.

Frequently Asked Questions

Immunine is used to replace deficient factor IX in patients with Hemophilia B, a genetic bleeding disorder. By providing the missing coagulation factor, it helps restore normal clotting function and prevents or controls bleeding episodes.

Human Coagulation Factor IX restores activity in the intrinsic pathway of the coagulation cascade. It binds to activated factor VIII, activates factor X, and ultimately leads to thrombin generation and fibrin clot formation, correcting the clotting defect in Hemophilia B.

The dose of Immunine is individualized. The prescribing clinician determines the amount and frequency based on the patient’s factor IX activity level, severity of bleeding, and clinical situation. No fixed regimen is provided here.

Safety data for Immunine in pregnancy and lactation are limited. Use is generally reserved for pregnant or nursing patients only when the potential benefit outweighs any possible risk, and decisions should be made by the treating physician.

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 if needed) and import documentation.

Immunine is a plasma‑derived factor IX concentrate similar in activity to other licensed factor IX products. Differences may lie in manufacturing processes, viral inactivation steps, and specific regulatory approvals. Clinical efficacy is comparable when appropriate dosing is applied.

Immunine must be stored at 2‑8 °C, protected from light, and should not be frozen or shaken. Keep the vial in its original packaging until use to maintain stability and potency.

Immunine is given by intravenous infusion. The infusion rate and volume are determined by the prescriber, and the product should be administered using aseptic technique in a clinical setting.

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

Immunine should not be used in individuals with known hypersensitivity to human plasma‑derived proteins or any component of the formulation. Caution is also advised for patients with a history of severe allergic reactions or uncontrolled cardiovascular disease.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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