Indications and Dosage¹

Venofer^® (iron sucrose injection, USP) is indicated in the treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy.

Venofer^® is contraindicated in:

• Patients with evidence of iron overload
• Patients with known hypersensitivity to iron sucrose or any of its inactive components
• Patients with anemia not caused by iron deficiency

Usual Dosage
Adults
100 mg iron administered intravenously 1 to 3 times per week to a total dose of 1000 mg in 10 doses. Repeat if needed. Frequency of dosing should be no more than 3 times weekly.

Slow Intravenous Injection
In chronic renal failure patients, Venofer^® may be administered by slow intravenous injection into the dialysis line at a rate of 1 mL (20 mg iron) undiluted solution per minute (ie, 5 minutes per vial) not exceeding 100 mg iron per injection. Discard any unused portion.

Infusion
Venofer^® may also be administered by drip infusion (or into the dialysis line for hemodialysis patients) in order to reduce the risk of hypotensive episodes. The content of each vial must be diluted in 100 mL 0.9% Sodium Chloride Injection, USP. The diluted solution should be infused at a rate of 100 mg of iron over a period of at least 15 minutes.

Monitoring Parameters

• Patients receiving regular parenteral iron therapy require monitoring of hematologic parameters and iron indices (Hb, Hct, TSAT, and ferritin)
• Sufficient IV iron should be administered to maintain TSAT between 20% and 50%
• Iron therapy should be withheld in patients with ferritin values ≥800 ng/mL and/or TSAT ≥50%
• Since transferrin saturation values increase rapidly after IV administration of iron sucrose, serum iron values may be reliably obtained 48 hours after IV dosing

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.
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