What Is Venofer®?
  Guidelines for Anemia Management
  Clinical Pharmacology
  Indications and Dosage
  Efficacy and Safety
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  Iron Deficiency
  Chronic Renal Failure
  Managing Iron Deficiency Anemia
  Key Learnings

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

Venofer® (iron sucrose injection, USP) is a brown, sterile, aqueous complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. It contains no preservatives or dextran polysaccharides. Venofer® is indicated in the treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy.

Over 50 Years of Worldwide Clinical Experience
Venofer® is used to replenish body iron stores in patients with iron deficiency on chronic hemodialysis who are receiving erythropoietin.1 Clinical trials and the long history of the use of iron sucrose injection worldwide have established the efficacy and safety of this drug in patients with iron deficiency anemia from chronic renal failure. Since 1992, over 40 million units have been sold in more than 66 countries.2

Large Safety Database
A large safety database on Venofer® (iron sucrose injection, USP) is available from clinical trial reports, publications, and postmarketing surveillance.

Data on the safety of Venofer® has been collected since its introduction to the European market (Switzerland) in 1950 and during a modern clinical development program begun in 1990. The clinical evaluation of Venofer® is based on results from 86 studies3-88 involving approximately 5773 subjects. More than 5000 patients were treated with Venofer®. These data, and the data observed in worldwide postmarketing surveillance, suggest that most adverse events are mild to moderate and are those commonly seen in patients with chronic renal failure or hemodialysis not receiving intravenous iron.1

Serious Adverse Reactions Related to Venofer® Are Uncommon
The incidence of serious adverse reactions is low. Based on an estimated use in 2 million patients that received Venofer® worldwide between 1992 and 2002, only 83 hypersensitivity reactions have been reported, including serious or life-threatening reactions.1

Contains No Dextran Polysaccharides
Venofer® contains no dextran polysaccharides, which are associated with antibody-induced anaphylaxis to iron dextran.

Safely Administered to Patients Intolerant of Other IV Iron Products
A total of 130 patients intolerant to other IV iron products (109 intolerant to iron dextran alone, 6 intolerant to ferric gluconate alone, 15 intolerant to both) were successfully treated with Venofer®. There were no discontinuations or serious adverse drug reactions. A total of 8 patients experienced one or more nonserious related adverse events. The most common were taste disturbance (4) and nausea (3).12,13,89

Convenient Single-Dose Vials, Preservative Free
The difficulties associated with glass ampules, such as breakage, splintering, and bodily injury to staff, have been eliminated. One 5-mL vial of Venofer® provides 100 mg of iron as iron sucrose, the NKF-K/DOQI—recommended dose for a single dialysis session.90 Venofer® contains no preservatives such as benzyl alcohol.

Administered by Slow Injection or by Infusion
Venofer® is easy to administer. Venofer® may be administered either by undiluted IV push injection (20 mg iron/min) or infusion (6.7 mg iron/min). This option gives healthcare providers the flexibility to deliver iron therapy in the most convenient way for the patient.

A Test Dose Is Not Required
Venofer® (iron sucrose injection, USP), unlike dextran iron products, does not require a test dose prior to therapy.12,13 However, during preapproval clinical trials, some patients received a test dose at the physician’s discretion. Staff vigilance when administering any intravenous iron product is recommended.

Nondialyzable
Results of a recently completed in vitro study1 found that Venofer® was not significantly removed by either high-efficiency or high-flux dialyzers.

Dissociated by Reticuloendothelial System (RES)
Following administration, the iron sucrose complex of Venofer® is picked up from the circulation and dissociated by the reticuloendothelial system.1

Comparison Chart
  Parameters Iron Dextran91,92 Iron Sucrose1 Iron Gluconate93,94
  Average Molecular
  Weights (daltons)		 100,000-300,000 34,000-60,000 289,000-440,000
  Release of Iron Slow Rapid Rapid
  PH 4.5-7 10.5-11.1 7.7-9.7
  How Supplied 50 mg/mL Dexferrum® 1 mL &
2 mL vials INFeD® 2 mL vial		 100 mg/5 mL vial 62.5 mg/5 mL ampule
  Preservative None None Benzyl Alcohol
  Test Dose Required Yes No No
  IV Push Yes, 100 mg over
2 min (50 mg/min)		 Yes, 100 mg over
5 min (20 mg/min) 		Yes, 125 mg over
10 min (12.5 mg/min)
  IV Infusion
  in Normal Saline		 No Yes—rate not to exceed
6.7 mg iron/minute		 Yes—rate not to exceed
2.1 mg iron/minute
  IM Administration INFeD®—Yes
Dexferrum®—No		 No No
  Usual Dose 100 mg IV push 100 mg IV push or infusion  125 mg IV push or infusion
  "Black Box" Warning Yes No No

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

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  2. Data on file. American Regent, Inc., Shirley, NY.
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