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 Factor IX concentrate presented as a solution for injection for intravenous use. It treats hemophilia B and acquired factor IX deficiency in patients with deficient coagulation factor IX.

GNH 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 Factor IX concentrate used to replace deficient clotting factor in the intrinsic pathway of the coagulation cascade.
  • Hemophilia B: restores normal clotting and reduces bleeding episodes.
  • Acquired factor IX deficiency: provides necessary factor IX to support hemostasis.

How It Works

  • Immunine supplies functional human factor IX, which binds to activated factor X on phospholipid surfaces, forming the intrinsic tenase complex. This restores the conversion of prothrombin to thrombin, enabling fibrin formation and normal clot development in patients lacking adequate endogenous factor IX.

Side Effects

Common Side Effects

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

Serious or Rare Side Effects

  • Anaphylactic or severe allergic reactions
  • Development of factor IX inhibitors (antibodies)
  • Thrombotic events
  • Viral transmission risk from plasma‑derived product
  • Hemolysis
  • Renal impairment

Precautions & Warnings

  • Immunine requires careful clinical monitoring and adherence to handling standards.
  • Dose individualized: dosing is based on factor IX activity levels and patient response.
  • Monitor for inhibitor development: regular testing for anti‑factor IX antibodies is recommended.
  • Assess for viral infections: screen donors and recipients for blood‑borne pathogens.
  • Use aseptic technique: ensure sterile preparation and administration to avoid contamination.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Immunine may interact with other agents affecting coagulation.

Major Interactions (Avoid)

  • Anticoagulants (e.g., warfarin, heparin): may counteract the clotting effect of factor IX.
  • Activated prothrombin complex concentrates: combined use increases thrombosis risk.

Moderate Interactions (Monitor Closely)

  • Antifibrinolytics (e.g., tranexamic acid): may enhance clot stability, monitor for excessive clotting.
  • Immunosuppressants: could influence inhibitor formation, require observation.
  • Live vaccines: timing may need adjustment to avoid interference with immune response.

Frequently Asked Questions

Immunine is a Factor IX concentrate indicated for the treatment and prophylaxis of bleeding in patients with hemophilia B (inherited factor IX deficiency) and for individuals with acquired factor IX deficiency. It replaces the missing clotting protein to help restore normal hemostasis.

Human Coagulation Factor IX supplied by Immunine binds to activated factor X on platelet surfaces, forming the intrinsic tenase complex. This complex accelerates the conversion of prothrombin to thrombin, leading to fibrin clot formation and effectively correcting the clotting defect caused by factor IX deficiency.

The dose of Immunine is individualized by the prescribing clinician based on the patient’s factor IX activity level, weight, severity of bleeding, and clinical response. Exact dosing regimens are determined by the treating physician and are not standardized in public information.

The safety of Immunine in pregnancy or while breastfeeding has not been definitively established. Healthcare providers should weigh the potential benefits against any unknown risks and consider alternative therapies if appropriate.

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, cold‑chain shipping details, and necessary import documentation.

Immunine is a plasma‑derived Factor IX concentrate, similar in activity to recombinant factor IX products. While recombinant forms avoid plasma‑derived pathogen risk, both provide comparable efficacy in correcting factor IX deficiency. Choice between them depends on physician preference, patient tolerance, and supply considerations.

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

Immunine is supplied as a sterile solution for injection and is administered intravenously. The infusion rate and volume are determined by the prescribing clinician, and the product should be given using aseptic technique in a clinical setting.

Serious risks include the development of inhibitory antibodies against factor IX, severe allergic or anaphylactic reactions, thrombotic events, and the theoretical risk of transmission of blood‑borne pathogens despite rigorous donor screening and viral inactivation processes.

Immunine should be avoided in patients with known hypersensitivity to any component of the product, in those who have previously developed inhibitors to factor IX, or in individuals with uncontrolled active thrombosis. Clinical judgment is required for each case.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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