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 solution for intravenous use. It is indicated for the treatment and prophylaxis of bleeding episodes in patients with hemophilia B (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. The company adheres to stringent quality standards and provides cold‑chain logistics to ensure product integrity during global distribution. Customer support is available 24/7 for regulatory assistance.

Manufacturer / TM Owner

Baxalta Innovations Gmbh

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Indications & Clinical Uses

Immunine is used to replace deficient factor IX in the intrinsic coagulation pathway for hemophilia B management.

  • Hemophilia B (Factor IX deficiency): Restores factor IX activity to control and prevent spontaneous and traumatic bleeding.
  • Surgical prophylaxis in hemophilia B: Provides temporary correction of factor IX levels to reduce peri‑operative bleeding risk.
  • On‑demand treatment of bleeding episodes: Supplies immediate factor IX replacement to stop active hemorrhage in patients with hemophilia B.

How It Works

  • Immunine supplies functional human coagulation factor IX, which binds to activated factor VIII on phospholipid surfaces, forming the tenase complex that catalyzes the conversion of factor X to factor Xa. This restores the intrinsic pathway of the coagulation cascade, leading to thrombin generation and fibrin clot formation, thereby correcting the deficiency that characterises hemophilia B.

Side Effects

Administration of Immunine may be associated with adverse reactions ranging from mild to severe.

Common Side Effects

  • Infusion‑related reactions such as mild fever, chills, or headache.
  • Nausea or vomiting.
  • Transient hypertension or blood pressure fluctuations.

Serious or Rare Side Effects

  • Anaphylactic or severe allergic reactions.
  • Development of neutralizing antibodies (inhibitors) to factor IX.
  • Thromboembolic events, including deep‑vein thrombosis.

Precautions & Warnings

Prior to initiating Immunine therapy, several safety considerations should be observed.

  • Monitor inhibitor development: test for anti‑factor IX antibodies periodically.
  • Assess for allergic reactions: discontinue if severe hypersensitivity occurs.
  • Use caution in patients with cardiovascular disease or hypertension.
  • Avoid in individuals with known hypersensitivity to human plasma‑derived proteins.
  • Pregnancy and lactation: safety not established; weigh risks and benefits.
  • Store 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.

Major Interactions (Avoid)

  • Concurrent anticoagulants (e.g., warfarin, heparin): may diminish therapeutic effect and increase bleeding risk.
  • Activated prothrombin complex concentrates: combined use can raise thrombosis risk.
  • Immunosuppressive therapy: may alter inhibitor formation and affect efficacy.

Moderate Interactions (Monitor Closely)

  • Other factor concentrates or plasma products: may increase inhibitor development.
  • Vaccinations (especially live vaccines): monitor for altered immune response.
  • CYP450‑modulating drugs: generally minimal impact but observe clinical response.

Frequently Asked Questions

Immunine is a prescription‑only biologic that provides human coagulation factor IX to replace the deficient protein in patients with hemophilia B. It is used for both on‑demand treatment of bleeding episodes and prophylactic management to prevent spontaneous hemorrhage.

Human Coagulation Factor IX supplied by Immunine binds to activated factor VIII on phospholipid surfaces, forming the tenase complex that converts factor X to factor Xa. This re‑establishes the intrinsic coagulation cascade, leading to thrombin generation and stable fibrin clot formation, thereby correcting the bleeding tendency in hemophilia B.

The dose of Immunine is individualized by the prescribing clinician based on the patient’s weight, baseline factor IX activity, severity of the bleed or surgical procedure, and target trough levels. Dosing calculations follow established hemophilia guidelines and are adjusted according to clinical response and laboratory monitoring.

Safety data for Immunine in pregnancy and lactation are limited, and the product is classified as having an unknown pregnancy category. Clinicians should weigh potential benefits against unknown risks, and use the drug only if clearly indicated. Breastfeeding mothers should consult their healthcare provider before use.

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 any necessary import documentation.

Immunine is a plasma‑derived human factor IX concentrate, whereas alternative products may be recombinant or extended‑half‑life formulations. Clinical efficacy is comparable for bleeding control, but differences exist in half‑life, infusion frequency, and immunogenicity risk. Choice of product depends on patient‑specific factors, treatment goals and physician preference.

Immunine must be stored refrigerated between 2 °C and 8 °C. It should be kept in its original container, protected from light, and must not be frozen or shaken. Prior to infusion, the solution may be allowed to reach room temperature, but any visible particles or discoloration require disposal.

Immunine is administered by intravenous infusion under the supervision of a qualified healthcare professional. The infusion rate is determined by the prescribing clinician and may be adjusted based on patient tolerance. Monitoring of vital signs and observation for infusion‑related reactions are recommended during and after administration.

The most serious risks include severe allergic or anaphylactic reactions, the development of neutralizing antibodies (inhibitors) that reduce efficacy, and thromboembolic events such as deep‑vein thrombosis. Patients should be educated to report any signs of rash, difficulty breathing, sudden pain, swelling or unexplained bruising promptly.

Immunine is contraindicated in individuals with known hypersensitivity to human plasma‑derived factor IX products or any of the excipients. Patients with a history of severe allergic reactions to factor concentrates should avoid use. Additionally, it should be used with caution in those with uncontrolled cardiovascular disease until risk is assessed.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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