• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Venofer (iron sucrose injection)

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Venofer (iron sucrose injection)

  • Profile

Profile

Contact Information

Contact: Vifor
Website: http://www.venofer.com/

Currently Enrolling Trials

    Show More

    General Information

    Venofer (iron sucrose injection) is a complex of polynuclear iron (3)-hydroxide in sucrose. It is approved for use in replenishing iron in patients receiving erythropoietin (a hormone that stimulates red blood cell production) and undergoing chronic hemodialysis, which involves filtering the blood in order to remove waste products. In these patients, an iron deficiency is caused by blood loss during the dialysis procedure, increased erythropoiesis (red blood cell production) and insufficient absorption of iron from the gastrointestinal tract. Iron is essential for the synthesis of hemoglobin, which is responsible for the transport of oxygen throughout the body.

    Mechanism of Action

    Following intravenous administration of Venofer, iron sucrose is dissociated by the reticuloendothelial system into iron and sucrose. Venofer's iron component appears to distribute mainly in the blood and to some extent in the extravascular fluid. A study evaluating Venofer containing 100 mg of iron labeled with 52Fe/59Fe in patients with iron deficiency showed that a significant amount of the administered iron distributes in the liver, spleen and bone marrow, and that the bone marrow is an iron trapping compartment and not a reversible volume of distribution (from FDA label).

    Side Effects

    Hypotension (low blood pressure) has been frequently reported in patients receiving intravenous iron, and may be related to the rate of administration of Venofer and to the total dose received. As a result, caution should be taken to ensure that Venofer is administered as directed.

    Adverse reactions noted in the three Venofer trials include the following (reported by more than 5 percent of the treated patients):

     

    • hypotension (36 percent)
    • cramps/leg cramps (23 percent)
    • nausea
    • headache
    • vomiting
    • diarrhea

    Additionally, serious hypersensitivity reactions have been reported in patients receiving therapy with iron carbohydrate complexes. While fatal hypersensitivity reactions have not been observed in Venofer clinical trials, physician vigilance is advised while any patient is receiving an intravenous iron product.

    Clinical Trial Results

    Three trials were conducted to assess the safety and effectiveness of Venofer. Two trials were conducted in the United States and one was conducted in South Africa.

    Study A was a multicenter, open-label, historically-controlled trial involving 101 hemodialysis patients (77 patients receiving Venofer and 24 patients in the historical control) with iron deficiency anemia. Venofer 5 mL (one vial) containing 100 mg of elemental iron was administered through the dialysis line at a total of 10 dialysis sessions with a cumulative dose of 1000 mg elemental iron. The mean change in hemoglobin from baseline to day 24 (end of treatment), day 36 and day 57 was assessed. Patients in the Venofer-treated population showed a statistically significant increase in hemoglobin and hematocrit compared to patients in the historical control population. Serum ferritin and transferrin saturation also increased significantly compared to the historical control.

    Study B was a multicenter, open-label trial of Venofer involving 23 iron deficient hemodialysis patients who had been discontinued from iron dextran due to intolerance. All 23 patients were evaluated for drug effectiveness and statistically significant increases in mean hemoglobin, hematocrit, serum ferritin and transferrin saturation were observed.

    Study C was a multicenter, open-label, two-period (treatment followed by observation period) trial in iron deficient hemodialysis patients. Venofer was administered in doses of 100 mg during sequential dialysis sessions until a pre-determined, calculated total dose of iron was administered. Twenty-seven patients (20 percent) were receiving erythropoietin treatment at trial entry and they continued to receive the same erythropoietin dose for the duration of the trial. Significant increases from baseline in mean hemoglobin, hematocrit, serum ferritin and serum transferrin saturation were observed at week 2 of the observation period and these values remained significantly increased at week 4 (from FDA label).

     

    Approval Date: 2000-11-01
    Company Name: Luitpold Pharmaceuticals
    Back to Listings

    Upcoming Events

    • 16Feb

      Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

    • 21May

      WCG MAGI Clinical Research Conference – 2023 East

    Featured Products

    • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

      Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    Featured Stories

    • Revamp-360x240.png

      Califf Calls for Major Evidence Generation Revamp, Experts’ Opinions Differ

    • AskTheExpertsGreen-360x240.png

      Ask the Experts: Managing Investigational Products

    • SurveywBlueBackground-360x240.png

      Survey Outlines Site Challenges, Successes on Diversity

    • PatientCentricity-360x240.png

      Site Spotlight: DM Clinical Shows Patient Centricity Doesn’t Have to Break the Bank

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell or Share My Data

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing