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 replacement therapy presented as an injectable solution for intravenous use. It is used to treat patients with Hemophilia B and other conditions involving 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 a recombinant factor IX product that restores the intrinsic pathway of the coagulation cascade in patients with factor IX deficiency.
  • Hemophilia B: provides the missing factor IX to enable normal clot formation and reduce bleeding episodes.
  • Acquired factor IX deficiency: restores clotting ability in patients who have lost factor IX due to disease or surgery.

How It Works

  • Human Coagulation Factor IX replaces the deficient endogenous factor IX in the intrinsic pathway of the coagulation cascade. By binding to activated factor VIII on phospholipid surfaces, it participates in the activation of factor X to Xa, leading to thrombin generation and formation of a stable fibrin clot, thereby correcting the bleeding tendency.

Side Effects

Immunine may be associated with adverse reactions following intravenous infusion.

Common Side Effects

  • Infusion‑related reactions such as mild fever or chills
  • Headache or mild arthralgia
  • Nausea or mild gastrointestinal discomfort

Serious or Rare Side Effects

  • Anaphylactic or severe allergic reactions
  • Development of neutralizing inhibitors (antibodies) against factor IX
  • Thrombotic events including deep‑vein thrombosis or pulmonary embolism

Precautions & Warnings

  • Before initiating therapy, clinicians should consider several safety measures.
  • Monitor for inhibitor development: assess antibody formation periodically.
  • Assess bleeding risk: evaluate patient history of severe hemorrhage.
  • Use aseptic technique: ensure sterile preparation and administration.
  • Adjust dose in renal or hepatic impairment: consider organ function when dosing.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Factor IX concentrates can interact with other agents that affect hemostasis.

Major Interactions (Avoid)

  • Concomitant anticoagulants (e.g., warfarin) may increase bleeding risk.
  • Use with activated prothrombin complex concentrates may predispose to thrombosis.
  • High‑dose immunoglobulins may reduce factor IX efficacy.

Moderate Interactions (Monitor Closely)

  • Aminoglycoside antibiotics may affect renal clearance of the product.
  • Live vaccines may have altered immune response when given concurrently.
  • Concurrent use of other clotting factor products requires careful monitoring of overall coagulation status.

Frequently Asked Questions

Immunine is a prescription intravenous concentrate of human coagulation factor IX. It is used to replace deficient factor IX in patients with Hemophilia B (congenital factor IX deficiency) and in individuals who have acquired factor IX deficiency due to surgery, liver disease, or other medical conditions.

Human Coagulation Factor IX restores the missing component of the intrinsic coagulation pathway. Once infused, it binds to activated factor VIII on phospholipid surfaces, participates in the activation of factor X, and ultimately leads to thrombin generation and fibrin clot formation, correcting the bleeding tendency.

The dose 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 response. Dosing is calculated to achieve target plasma factor IX levels appropriate for the specific clinical situation.

Safety data for Immunine in pregnancy and lactation are limited. Because factor IX replacement is often required for women with Hemophilia B, the benefits and potential risks should be evaluated by the treating physician. The prescriber should discuss any concerns and consider the most current clinical guidelines.

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 logistics if needed) and any required import documentation.

Immunine is a recombinant human factor IX concentrate similar in efficacy to other licensed factor IX products. Differences may lie in manufacturing processes, stabilizers, and storage requirements. Clinicians typically choose a product based on clinical experience, patient tolerance, availability, and cost considerations.

Immunine must be stored refrigerated at 2 °C to 8 °C. It should be kept in its original container, protected from light, and must not be frozen or shaken. If temperature excursions occur, the product should be inspected for any changes before use.

Immunine is given by intravenous infusion. The infusion rate and volume are determined by the prescriber based on the calculated dose. Administration should be performed in a clinical setting with appropriate monitoring for infusion‑related reactions and under aseptic conditions.

The most serious risks include the development of neutralizing antibodies (inhibitors) against factor IX, which can reduce efficacy, and rare but severe hypersensitivity reactions such as anaphylaxis. Thrombotic complications may also occur, especially if dosing exceeds target plasma levels.

Immunine is contraindicated in patients with known hypersensitivity to any component of the formulation. It should also be avoided in individuals who have previously developed inhibitors to factor IX unless a specialist determines that benefits outweigh risks.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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