Product image of Jivi (Damoctocog Alfa Pegol) supplied by GNH India

Jivi

Active Ingredient:
Damoctocog Alfa Pegol
Origin:
EU

Jivi (Damoctocog Alfa Pegol)

Damoctocog alfa pegol, the active ingredient in Jivi, is a recombinant factor VIII (PEGylated) presented as a solution for injection for intravenous use. It replaces deficient clotting factor VIII in patients with hemophilia A to prevent and treat bleeding episodes.
GNH India supplies Jivi as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Bayer Ag

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Indications & Clinical Uses

Jivi is used within the hemophilia A treatment pathway to restore clotting function.

  • Hemophilia A (congenital factor VIII deficiency) – prophylaxis of bleeding episodes: maintains sufficient factor VIII levels to reduce spontaneous bleeds.
  • Hemophilia A – on‑demand treatment of acute bleeding episodes: provides rapid factor VIII activity to stop active bleeding.
  • Hemophilia A during surgery – peri‑operative hemostasis: supplies factor VIII to achieve adequate clot formation during surgical procedures.

How It Works

  • Damoctocog alfa pegol is a PEGylated recombinant factor VIII protein that circulates in the plasma and replaces the missing endogenous factor VIII. By binding to activated factor IX, it restores the intrinsic tenase complex, enabling activation of factor X, generation of thrombin, and formation of a stable fibrin clot, thereby correcting the coagulation defect in hemophilia A patients.

Side Effects

Jivi may be associated with adverse reactions following intravenous administration.

Common Side Effects

  • Infusion site erythema or pain
  • Headache
  • Fever or chills
  • Nausea or abdominal discomfort
  • Fatigue or malaise

Serious or Rare Side Effects

  • Development of inhibitory antibodies against factor VIII
  • Anaphylactic or severe hypersensitivity reactions
  • Thromboembolic events such as deep‑vein thrombosis
  • Hepatic enzyme elevations
  • Hemolysis or renal impairment

Precautions & Warnings

Prior to initiating therapy, clinicians should evaluate patient history and monitor for specific risks.

  • Monitor inhibitor development: perform regular factor VIII activity assays.
  • Assess for allergic reactions: observe patients during and after infusion.
  • Avoid use in patients with known hypersensitivity to PEGylated proteins.
  • Use caution in individuals with a history of thrombosis: evaluate risk factors.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Jivi can interact with other agents that affect coagulation or immune response.

Major Interactions (Avoid)

  • Concurrent use of bypassing agents (e.g., activated prothrombin complex concentrate) may increase thrombotic risk.
  • Co‑administration with anticoagulants (warfarin, DOACs) can reduce hemostatic efficacy.
  • Simultaneous infusion of other factor VIII products may provoke immune sensitisation.

Moderate Interactions (Monitor Closely)

  • Live vaccines may have altered immunogenicity; monitor response.
  • Immunosuppressive therapy could affect inhibitor formation; assess regularly.
  • High‑dose intravenous immunoglobulin may interfere with factor VIII activity assays.

Frequently Asked Questions

Jivi is indicated for patients with hemophilia A to provide prophylactic protection against spontaneous bleeding, to treat acute bleeding episodes on demand, and to support hemostasis during surgical procedures by replacing deficient factor VIII activity.

Damoctocog alfa pegol is a PEGylated recombinant factor VIII that restores the intrinsic tenase complex. It binds activated factor IX, enabling conversion of factor X to Xa, which generates thrombin and leads to fibrin clot formation, correcting the clotting defect in hemophilia A.

The dose of Jivi is individualized. The prescribing clinician determines the amount and frequency based on the patient’s weight, severity of hemophilia, type of bleed, and surgical needs, following established hemophilia treatment guidelines.

Safety data for damoctocog alfa pegol in pregnancy and lactation are limited. Use should be considered only if the potential benefit justifies any potential risk to the fetus or infant, and decisions are made in consultation with a specialist obstetrician and hematologist.

To order Jivi, submit an enquiry on the product page at gnhindia.com indicating 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 necessary import documentation.

Jivi is a PEGylated recombinant factor VIII, offering an extended half‑life compared with conventional non‑PEGylated factor VIII concentrates. This can reduce infusion frequency for prophylaxis while maintaining comparable efficacy and safety profiles, making it a convenient option for many patients.

Jivi should be stored refrigerated at 2‑8 °C, protected from light, and must not be frozen or shaken. Prior to use, inspect the solution for particulate matter and ensure the vial is at room temperature if required by the administration protocol.

Jivi is supplied as a sterile solution for injection and is administered intravenously. The infusion is performed by a healthcare professional, typically using a controlled-rate infusion set, and the patient is monitored for any immediate adverse reactions.

The most serious risks include the development of inhibitory antibodies against factor VIII, which can diminish efficacy, and rare severe hypersensitivity reactions such as anaphylaxis. Thromboembolic events have also been reported and require prompt medical attention.

Jivi is contraindicated in patients with known hypersensitivity to damoctocog alfa pegol, any of its excipients, or other PEGylated proteins. It should also be avoided in individuals who have experienced severe allergic reactions to previous factor VIII products.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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