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> How Effective Is Venofer®?

How Effective Is Venofer® (iron sucrose injection, USP)?

Venofer® (iron sucrose injection, USP) has been proven to be an effective means of treating iron deficiency anemia in patients undergoing hemodialysis and receiving epoetin therapy. Three important clinical trials of Venofer® were conducted prior to FDA approval to assess how effective it is, as well as how safe it is1:

  • Study A: a US study looking at the effectiveness and safety of Venofer® in patients with iron deficiency anemia who were undergoing long-term hemodialysis and receiving supplemental epoetin therapy
  • Study B: a US study examining the safety and effectiveness of Venofer® in iron-deficient hemodialysis patients who had been stopped from taking iron dextran injection because of intolerance to it and who were still receiving supplemental epoetin therapy
  • Study C: a study conducted in South Africa looking at the safety and effectiveness of Venofer® in hemodialysis patients with iron deficiency anemia

The key findings of these three studies are discussed below.

Study A
This study showed the effectiveness and safety of Venofer® (iron sucrose injection, USP) compared with a historical control group (a comparison group of 24 patients consisting of a population and corresponding data from past clinical experience) in 77 iron-deficient hemodialysis patients.2

Venofer® treatment led to significant increases in:

  • Hemoglobin (Hb), the oxygen-carrying pigment in red blood cells
  • Hematocrit (HCT), the percentage of the volume of a blood sample occupied by cells
  • Transferrin saturation (TSAT), the amount of protein-bound iron in circulation
  • Serum ferritin, the soluble form of iron-protein storage complex, containing up to 23% of iron, in circulation

A rapid response to Venofer® treatment was seen, with a significant increase in Hb in the treatment group by the 24th day of treatment compared with the historical control group.1 When Venofer® was given by IV as 100-mg doses at consecutive dialysis sessions (with or without a test dose), it was well tolerated. None of the 77 people receiving Venofer® in the study had serious treatment-related side effects.

Study B
This study showed Venofer® was safe when given as 100-mg doses, without serious side effects to the drug and without low blood pressure, in patients who cannot tolerate iron dextran injection. Twenty-two patients completed Venofer® treatment.3 They had a mean age of 53 years. Nearly half of the patients also had a history of allergy to at least one medication in addition to iron dextran.3

After 24 days, Venofer® treatment produced significant increases in Hb, HCT, TSAT, and serum ferritin in patients who were receiving epoetin for dialysis-associated anemia.3

Study C
This study was conducted at several locations in South Africa. It assessed the effectiveness and safety of Venofer® in hemodialysis patients with iron deficiency anemia.1,4 A total of 105 patients were evaluated for the effectiveness of Venofer® treatment.4

Venofer® was found to be well-tolerated by the people in the study. The treatment was effective in raising Hb levels and replenishing iron stores in these hemodialysis patients with iron deficiency anemia. The benefits of taking Venofer® continued for one month after completing the treatment.4

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.

References

  1. Venofer® [package insert]. Shirley, NY: American Regent, Inc.; 2003.
  2. Charytan C, Levin N, Al-Saloum M, et al. Efficacy and safety of iron sucrose for iron deficiency in patients with dialysis-associated anemia: North American clinical trial. Am J Kidney Dis. 2001;37:300-307.
  3. Van Wyck DB, Cavallo G, Spinowitz BS, et al. Safety and efficacy of iron sucrose in patients sensitive to iron dextran: North American clinical trial. Am J Kidney Dis. 2000;36:88-97.
  4. Data on file. American Regent, Inc., Shirley, NY.

 

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