Product image of Immunate (Human Coagulation Factor Viii, Human Von Willebrand Factor) supplied by GNH India

Immunate

Active Ingredient:
Human Coagulation Factor Viii, Human Von Willebrand Factor
Origin:
EU

Immunate (Human Coagulation Factor Viii, Human Von Willebrand Factor)

Human Coagulation Factor VIII and Human von Willebrand Factor, the active ingredient in Immunate, is a coagulation factor replacement presented as a solution for injection for intravenous use. It treats hemophilia A and von Willebrand disease by providing the missing clotting proteins.

GNH India supplies Immunate 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

Immunate is used to replace deficient clotting proteins in inherited bleeding disorders.

  • Hemophilia A: restores factor VIII activity to achieve hemostasis during bleeding episodes and surgery.
  • Von Willebrand disease: supplies von Willebrand factor to improve platelet adhesion and stabilize factor VIII.
  • Peri‑operative management in patients with combined factor VIII/vWF deficiency: provides hemostatic coverage before, during, and after surgical procedures.

How It Works

  • Immunate supplies exogenous human factor VIII and von Willebrand factor, which bind to exposed subendothelial collagen and platelets, facilitating platelet adhesion and aggregation. The added factor VIII participates in the intrinsic coagulation cascade, converting factor X to Xa, ultimately generating thrombin and fibrin to form a stable clot.

Side Effects

Immunate may cause a range of adverse reactions following intravenous administration.

Common Side Effects

  • Infusion‑related reactions (e.g., flushing, chills, fever)
  • Headache
  • Nausea or vomiting
  • Arthralgia or muscle aches
  • Mild hypertension
  • Local site erythema or swelling

Serious or Rare Side Effects

  • Development of inhibitory antibodies against factor VIII or von Willebrand factor
  • Anaphylactic or severe allergic reactions
  • Thromboembolic events (deep vein thrombosis, pulmonary embolism)
  • Renal dysfunction or acute kidney injury
  • Severe hypotension or shock
  • Transmission of blood‑borne pathogens (theoretical risk).

Precautions & Warnings

Before using Immunate, clinicians should consider several safety measures.

  • Monitor for inhibitor development: assess factor activity levels regularly.
  • Assess for hypersensitivity: observe patients during the first infusion for signs of allergic reaction.
  • Use with caution in patients with cardiovascular disease or a history of thrombosis.
  • Avoid in individuals with known hypersensitivity to plasma‑derived products.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Immunate can interact with other agents that affect coagulation.

Major Interactions (Avoid)

  • Concomitant use of other factor VIII or von Willebrand factor concentrates: may increase risk of excessive clot formation.
  • High‑dose procoagulant agents (e.g., activated prothrombin complex concentrate): heightened thrombosis risk.

Moderate Interactions (Monitor Closely)

  • Anticoagulants (warfarin, direct oral anticoagulants): may reduce the hemostatic efficacy of Immunate.
  • Antifibrinolytics (tranexamic acid, aminocaproic acid): may potentiate clot stability and increase thrombosis risk.
  • Immunosuppressive therapies: could affect inhibitor development and immune response.

Frequently Asked Questions

Immunate is indicated for the replacement therapy of patients with hemophilia A and von Willebrand disease. It provides the missing clotting proteins to help control bleeding episodes and to support surgical or invasive procedures in these inherited bleeding disorders.

The factor VIII component participates in the intrinsic pathway of the coagulation cascade, converting factor X to Xa and ultimately generating thrombin. The von Willebrand factor stabilizes factor VIII in circulation and promotes platelet adhesion to damaged vascular surfaces, together restoring normal hemostasis.

The dose of Immunate is individualized and determined by the prescribing clinician based on the patient’s weight, severity of deficiency, type of bleeding episode, and surgical requirements. The prescriber calculates the required units to achieve target factor levels and adjusts as needed.

Safety data for Immunate in pregnancy and lactation are limited. The decision to use the product should be made by a qualified healthcare professional after weighing the potential benefits for the mother against any possible risks to the fetus or infant.

To request Immunate, 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 handling if needed), and import documentation.

Immunate is a plasma‑derived concentrate containing both factor VIII and von Willebrand factor, offering dual replacement in a single product. Compared with recombinant factor VIII products, Immunate may provide additional von Willebrand activity, which can be advantageous for patients with combined deficiencies, though the choice depends on individual clinical needs and product availability.

Immunate should be stored refrigerated at 2‑8 °C. Keep the vial in its original packaging, protect it from light, and avoid freezing or shaking the solution. If temperature excursions occur, consult the product’s stability guidelines before use.

Immunate is supplied as a sterile solution for injection and is administered intravenously. The infusion rate and volume are determined by the prescriber, and patients are typically monitored during and after the infusion for any adverse reactions.

Serious risks include the development of inhibitory antibodies against factor VIII or von Willebrand factor, severe allergic or anaphylactic reactions, and thromboembolic events such as deep‑vein thrombosis or pulmonary embolism. Prompt recognition and management of these events are essential.

Immunate is contraindicated in individuals with known hypersensitivity to any component of the product, including plasma‑derived proteins. Patients with a history of severe allergic reactions to factor concentrates should avoid its use, and clinicians should assess each case individually.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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