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What Is Venofer® (iron sucrose injection, USP)?

The Food and Drug Administration approved Venofer® (iron sucrose injection, USP) for use in the United States on November 6, 2000. However, Venofer® has been available in other countries since 1950. Currently, it is sold in more than 66 countries.1 From 1992 through 2002, more than 40 million units of Venofer® were prescribed.1

Venofer® is a brown liquid. It contains water and iron. It is used for intravenous injections. Each 5-mL single-dose vial of Venofer® has 100 mg of elemental iron as iron sucrose in water for injection. Venofer® contains no preservatives. It has no dextran polysaccharides, which can cause allergic reactions in some people. Venofer® does not contain benzyl alcohol, a preservative found in other IV iron products.

Venofer® (iron sucrose injection, USP) is used for the treatment of iron deficiency anemia in patients who are undergoing hemodialysis on a regular basis and who are receiving additional therapy using epoetin.2 Epoetin is a special man-made protein that helps to stimulate red blood cell production.1

Venofer® should not be given to patients who:

  • Show evidence of iron overload
  • Have an abnormal sensitivity to Venofer® or any of its inactive components
  • Have anemia not caused by iron deficiency

Venofer® is meant to be used as a first-line therapy. This means if you develop iron deficiency anemia during your regular hemodialysis treatments, and you are being given epoetin, your doctor might turn to Venofer® first to help you.

IMPORTANT SAFETY INFORMATION
Venofer® (iron sucrose injection, USP) is contraindicated in patients with evidence of iron overload, in patients with known hypersensitivity to Venofer® or any of its inactive components, and in patients with anemia not caused by iron deficiency. Hypersensitivity reactions have been reported with injectable iron products. Hypotension has been reported frequently in patients receiving intravenous iron. Hypotension following administration of Venofer® may be related to rate of administration and total dose delivered. In multidose efficacy studies (N=231), the most frequent adverse events, whether or not related to Venofer® administration, were hypotension, cramps/leg cramps, nausea, headache, vomiting, and diarrhea. In postmarketing safety studies (N=1051), the most frequent adverse events reported (>1%) were congestive heart failure, sepsis, and taste perversion.
Please see Full Prescribing Information.

Venofer® is a registered trademark of Vifor (International) Inc.

References

  1. Data on file. American Regent, Inc., Shirley, NY.
  2. Venofer® [package insert]. Shirley, NY: American Regent, Inc.; 2003.

 

 

 

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