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 presented as an intravenous formulation for use in patients with inherited or acquired deficiencies of factor IX. It is employed to treat Hemophilia B and acquired factor IX deficiency by restoring normal clotting function.

GNH India supplies Immunine as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, adhering to strict quality standards and providing reliable global distribution.

Manufacturer / TM Owner

Takeda Gmbh

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Indications & Clinical Uses

  • Immunine is used to replace deficient factor IX in the intrinsic coagulation pathway for several clinical conditions.
  • Hemophilia B: restores clotting ability and reduces bleeding episodes in patients with congenital factor IX deficiency.
  • Acquired factor IX deficiency: corrects the deficiency caused by liver disease, vitamin K antagonists, or inhibitors, supporting hemostasis.
  • Surgical prophylaxis in factor IX‑deficient patients: provides adequate clotting factor levels to prevent peri‑operative bleeding.

How It Works

  • Human Coagulation Factor IX is a plasma‑derived or recombinant protein that directly participates in the intrinsic pathway of the coagulation cascade. When administered intravenously, it binds to factor VIIIa on activated platelets, catalyzing the conversion of factor X to Xa, which leads to thrombin generation and fibrin clot formation, thereby compensating for the patient’s deficient endogenous factor IX activity.

Side Effects

Immunine may be associated with a range of adverse reactions following intravenous infusion.

Common Side Effects

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

Serious or Rare Side Effects

  • Anaphylaxis or severe allergic reaction
  • Development of neutralizing antibodies (inhibitors) against factor IX
  • Thrombotic events such as deep‑vein thrombosis
  • Transmission of infectious agents (viral contamination)

Precautions & Warnings

  • When using Immunine, clinicians should observe several safety measures to minimize risks.
  • Inhibitor monitoring: regularly test for anti‑factor IX antibodies that can reduce efficacy.
  • Allergy assessment: screen for prior hypersensitivity to plasma proteins or recombinant factor IX.
  • Concomitant anticoagulants: evaluate bleeding risk if patient is receiving warfarin or heparin.
  • Liver function: assess hepatic status as it may affect factor metabolism.
  • Surgical planning: ensure adequate factor levels are achieved before invasive procedures.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Immunine can interact with other medicines that affect hemostasis or immune response.

Major Interactions (Avoid)

  • Anticoagulants (e.g., warfarin, direct oral anticoagulants): may diminish the hemostatic effect of factor IX.
  • Other pro‑coagulant agents (e.g., activated prothrombin complex concentrates): increase risk of thrombosis.
  • Immunosuppressive biologics: may alter inhibitor development.

Moderate Interactions (Monitor Closely)

  • Certain antibiotics (e.g., aminoglycosides): may affect plasma protein binding.
  • Antifibrinolytics (e.g., tranexamic acid): may enhance clot stability, requiring dose adjustment.
  • Live‑attenuated vaccines: monitor for immune reactions.

Frequently Asked Questions

Immunine is a prescription‑only intravenous product that provides human coagulation factor IX to patients who lack sufficient endogenous factor IX. It is indicated for the treatment and prophylaxis of bleeding in individuals with Hemophilia B (congenital factor IX deficiency) and for acquired factor IX deficiency caused by liver disease, vitamin K antagonists, or other conditions that reduce factor IX levels.

Human Coagulation Factor IX replaces the missing or deficient factor IX in the intrinsic pathway of the coagulation cascade. Once infused, it binds to factor VIIIa on activated platelets and catalyzes the conversion of factor X to Xa, leading to thrombin generation and fibrin clot formation, thereby restoring normal hemostasis.

The dose of Immunine is individualized and set by the prescribing physician based on the patient’s weight, severity of factor IX deficiency, target plasma activity level, and the clinical situation (e.g., on‑demand treatment versus prophylaxis). Dosing regimens are not standardized and must be determined by a qualified healthcare professional.

Data on the use of Immunine in pregnancy and lactation are limited. Because uncontrolled bleeding poses a risk to both mother and fetus, the decision to use factor IX replacement therapy should be made after a careful risk‑benefit assessment by the treating physician. Women who are pregnant or nursing should discuss potential risks with their healthcare provider.

To request Immunine, submit an enquiry on the product page at gnhindia.com indicating the required quantity. GNH India supplies hospitals, pharmacies and procurement teams across international markets. After the enquiry, the sales team will verify trade or institutional credentials, then provide pricing, availability, shipping details (including cold‑chain handling if required) and any necessary import documentation.

Immunine contains human coagulation factor IX and is administered intravenously, similar to other plasma‑derived or recombinant factor IX concentrates. Compared with some recombinant products, Immunine may have a comparable safety profile but specific differences in purity, half‑life, and manufacturing processes can influence dosing frequency and immunogenicity. Clinicians choose a product based on patient history, inhibitor status, and therapeutic goals.

Immunine must be stored at 2‑8 °C (refrigerated). It should be kept in its original packaging, protected from light, and must not be frozen or shaken. If the product reaches room temperature for a short period during administration, it should be returned to the refrigerator promptly and used within the time frame specified by the manufacturer.

Immunine is given by intravenous infusion under the supervision of a qualified healthcare professional. The infusion rate and volume are determined by the prescribing clinician based on the prescribed dose and the patient’s vascular access. Monitoring for infusion‑related reactions is recommended during and after the administration.

The most serious adverse events associated with Immunine include severe allergic reactions such as anaphylaxis, the development of neutralizing antibodies (inhibitors) that reduce treatment efficacy, and thrombotic complications like deep‑vein thrombosis. Additionally, because the product is derived from human plasma, there is a theoretical risk of viral transmission, although manufacturing processes aim to minimize this risk.

Immunine is contraindicated in individuals with a known hypersensitivity to human coagulation factor IX, any component of the formulation, or a history of severe allergic reactions to similar products. Patients with active, uncontrolled thrombosis should avoid use until the condition is stabilized. Use in patients with uncertain inhibitor status should be guided by specialist assessment.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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