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 sterile concentrate for intravenous use. It supplies deficient clotting factors to restore hemostasis in patients with hemophilia A and von Willebrand disease.

GNH India supplies Immunate as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide, meeting stringent quality standards and regulatory requirements. The product is manufactured under GMP conditions and distributed with cold‑chain logistics to preserve stability.

Manufacturer / TM Owner

Baxalta Innovations Gmbh

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Indications & Clinical Uses

Immunate is used to replace deficient clotting factors in the coagulation cascade for inherited bleeding disorders.

  • Hemophilia A: Provides factor VIII to achieve adequate clot formation and reduce bleeding episodes.
  • Von Willebrand disease: Supplies von Willebrand factor to improve platelet adhesion and stabilize factor VIII, decreasing bleeding frequency.
  • Surgical or invasive procedures: Offers temporary hemostatic coverage to prevent peri‑operative bleeding in patients with hemophilia A or von Willebrand disease.

How It Works

  • Immunate delivers functional human factor VIII and von Willebrand factor directly into the bloodstream. Factor VIII participates in the intrinsic pathway of the coagulation cascade, forming a complex with factor IXa to activate factor X, while von Willebrand factor mediates platelet adhesion to subendothelial collagen and stabilizes circulating factor VIII, together restoring effective hemostasis in deficient patients.

Side Effects

Common Side Effects

  • Infusion‑related reactions such as chills or flushing.
  • Fever or mild temperature elevation.
  • Headache.
  • Nausea or vomiting.

Serious or Rare Side Effects

  • Anaphylactic or severe allergic reactions.
  • Development of neutralizing antibodies (inhibitors) against factor VIII or VWF.
  • Thromboembolic events, including deep vein thrombosis or pulmonary embolism.

Precautions & Warnings

Before initiating therapy, assess inhibitor status and baseline clotting parameters.

  • Monitor for signs of allergic reaction during infusion: stop infusion if severe symptoms occur.
  • Use caution in patients with cardiovascular disease or a history of thrombosis.
  • Avoid concurrent use with other pro‑coagulant agents unless clinically indicated.
  • Store at 2‑8 °C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Immunate may interact with other agents affecting hemostasis.

Major Interactions (Avoid)

  • Concurrent use with activated prothrombin complex concentrates (aPCC) may increase thrombosis risk.
  • Combined therapy with other clotting factor concentrates can lead to excess clot formation.
  • Use with high‑dose anticoagulants (e.g., warfarin, heparin) may diminish therapeutic effect.

Moderate Interactions (Monitor Closely)

  • Desmopressin (DDAVP) may augment VWF levels; monitor for hypercoagulability.
  • NSAIDs can increase bleeding tendency; observe for signs of hemorrhage.
  • Immunosuppressants may affect inhibitor development; assess inhibitor titres regularly.

Frequently Asked Questions

Immunate is indicated for the replacement of deficient clotting factors in patients with hemophilia A and von Willebrand disease. It is also used to provide temporary hemostatic support during surgical or invasive procedures in individuals with these inherited bleeding disorders.

The product supplies functional factor VIII, which participates in the intrinsic coagulation pathway, and von Willebrand factor, which promotes platelet adhesion and stabilizes factor VIII. Together they restore the normal clotting cascade, allowing effective formation of a fibrin clot and reducing bleeding.

Dosing of Immunate is individualized and determined by the prescribing clinician based on the patient’s weight, severity of deficiency, type of procedure, and laboratory monitoring. The prescriber calculates the required units to achieve target factor levels and adjusts subsequent doses as needed.

Limited clinical data are available for use of factor VIII/VWF concentrates in pregnancy and lactation. The potential benefits should be weighed against any unknown risks, and treatment decisions should be made by a specialist in consultation with the obstetric team.

To order 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, cold‑chain shipping details and any necessary import documentation.

Immunate is a plasma‑derived concentrate containing both factor VIII and von Willebrand factor, whereas many alternatives are recombinant single‑component products (e.g., recombinant factor VIII). The combined formulation can simplify dosing for patients who need both activities, but recombinant products may have a lower risk of pathogen transmission.

Immunate must be stored refrigerated at 2 °C to 8 °C. Keep the vial in its original packaging, protect it from light, and avoid freezing or shaking the product. Do not use if the solution appears discolored or contains particles.

Immunate is given by intravenous infusion. The recommended infusion rate and total dose are set by the treating physician and are based on the patient’s clinical condition and laboratory results. Infusion should be performed under medical supervision with appropriate monitoring for reactions.

The most serious risks include the development of neutralizing antibodies (inhibitors) against factor VIII or VWF, severe allergic or anaphylactic reactions, and thromboembolic events such as deep‑vein thrombosis or pulmonary embolism. Immediate medical attention is required if any of these occur.

Immunate is contraindicated in individuals with a known hypersensitivity to any of its components, including human plasma proteins. Patients with a history of severe allergic reactions to factor concentrates should avoid its use until evaluated by a specialist.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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