Product image of Immuseven (Human Coagulation Factor Vii) supplied by GNH India

Immuseven

Active Ingredient:
Human Coagulation Factor Vii
Origin:
EU

Immuseven (Human Coagulation Factor Vii)

Human Coagulation Factor VII, the active ingredient in Immuseven, is a coagulation factor presented as a sterile intravenous solution for intravenous use. It is employed to manage bleeding in patients with specific clotting deficiencies and is administered under specialist supervision.

GNH India supplies Immuseven as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals worldwide. The company follows stringent quality standards and provides cold‑chain logistics to ensure product integrity across global markets. Clients benefit from reliable delivery, regulatory support, and comprehensive technical assistance.

Manufacturer / TM Owner

Takeda Gmbh

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Indications & Clinical Uses

Immuseven is used to replace deficient factor VII activity in the extrinsic coagulation pathway for several bleeding disorders.

  • Congenital factor VII deficiency: restores clotting ability to control spontaneous and trauma‑related bleeding.
  • Hemophilia A or B with inhibitors: provides hemostasis during bleeding episodes when standard factor replacement is ineffective.
  • Acquired hemophilia or severe surgical bleeding: achieves rapid clot formation to limit blood loss.
  • Severe trauma in patients with coagulopathy: supplies immediate factor VII activity to support emergency hemostasis.

How It Works

  • Immuseven supplies exogenous human coagulation factor VII, which binds to tissue factor exposed at vascular injury sites. This complex activates factor X to Xa, initiating the extrinsic coagulation cascade and generating thrombin. The resulting fibrin clot stabilizes the hemorrhage, providing rapid hemostasis in patients lacking functional endogenous factor VII. The activity is dose‑dependent and enhances clot formation without requiring the intrinsic pathway.

Side Effects

Administration of Immuseven may be associated with a range of adverse reactions, varying from mild to serious.

Common Side Effects

  • Fever: mild temperature elevation occurring shortly after infusion.
  • Headache: transient cranial discomfort reported by some patients.
  • Nausea: occasional gastrointestinal upset following administration.
  • Injection site reactions: redness, swelling, or discomfort at the infusion site.

Serious or Rare Side Effects

  • Thromboembolic events: formation of clots in veins or arteries, potentially leading to stroke or pulmonary embolism.
  • Hypotension: sudden drop in blood pressure during or after infusion.
  • Allergic reactions: anaphylaxis, urticaria, or severe skin eruptions requiring immediate medical attention.

Precautions & Warnings

Prior to using Immuseven, clinicians should evaluate patient history and monitor for specific risks.

  • Thrombotic risk assessment: evaluate for prior clotting disorders or cardiovascular disease.
  • Inhibitor screening: test for antibodies that may neutralize factor VII activity.
  • Specialist supervision: administer only under the guidance of a hematology or coagulation expert.
  • Hypersensitivity check: avoid use in patients with known allergy to recombinant factor VII products.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Immuseven can interact with other medications that affect hemostasis, requiring careful management.

Major Interactions (Avoid)

  • Concomitant use with other clotting factor concentrates: may increase risk of thrombotic complications.
  • High‑dose estrogen therapy: additive pro‑coagulant effect can precipitate clot formation.
  • Antifibrinolytic agents (e.g., tranexamic acid) combined with high doses: heightened thrombosis potential.

Moderate Interactions (Monitor Closely)

  • Anticoagulants (warfarin, heparin, direct oral anticoagulants): may diminish the hemostatic effect of Immuseven.
  • Antiplatelet drugs (aspirin, clopidogrel): may require dose adjustment and close monitoring of bleeding parameters.

Frequently Asked Questions

Immuseven is indicated for the treatment of bleeding associated with congenital factor VII deficiency, for controlling hemorrhage in hemophilia A or B patients who have developed inhibitors, and for managing severe bleeding in acquired hemophilia or during major surgery when rapid clot formation is required.

Human Coagulation Factor VII supplied by Immuseven binds to tissue factor at sites of vascular injury, forming a complex that activates factor X to Xa. This triggers the extrinsic coagulation cascade, leading to thrombin generation and fibrin clot formation, thereby restoring hemostasis in patients lacking functional factor VII.

The dose of Immuseven is individualized by the prescribing clinician based on the patient’s weight, severity of bleeding, underlying diagnosis, and laboratory parameters such as factor VII activity levels. No fixed regimen is provided; dosing decisions are made by qualified healthcare professionals.

Data on the use of recombinant factor VII in pregnancy and lactation are limited. The drug should be used only if the potential benefit justifies any potential risk to the fetus or infant, and the decision should be made by the treating physician in consultation with obstetric specialists.

To order Immuseven, 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), and any necessary import documentation.

Immuseven is a recombinant human factor VIIa, offering a high purity profile and consistent activity compared with plasma‑derived preparations. It eliminates the risk of pathogen transmission associated with blood‑derived products and provides rapid onset of action, making it a preferred option for many specialists managing inhibitor‑positive hemophilia and congenital deficiency.

Immuseven must be stored refrigerated at 2‑8 °C. It should be kept in the original container, protected from light, and must not be frozen or shaken. Prior to administration, inspect the solution for particulate matter and ensure the vial remains within the recommended temperature range.

Immuseven is given by intravenous infusion under aseptic conditions. The infusion rate and total dose are determined by the treating physician, and the product is typically administered through a dedicated IV line using a sterile syringe or infusion set, following standard hospital protocols for biologic agents.

The most serious adverse events include thromboembolic complications such as deep‑vein thrombosis, pulmonary embolism, or stroke, as well as severe hypersensitivity reactions including anaphylaxis. Clinicians should monitor patients closely for signs of clot formation or allergic response during and after infusion.

Immuseven is contraindicated in patients with known hypersensitivity to recombinant factor VIIa or any of the product’s excipients. Caution is also advised for individuals with a history of thromboembolic disease, uncontrolled hypertension, or active disseminated intravascular coagulation, where the risk‑benefit ratio must be carefully evaluated.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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