Pharmacy Specifications

Dosage Form
Venofer^® (iron sucrose injection, USP) is available in 5-mL single-dose vials. Each 5-mL vial contains 100 mg (20 mg/mL) of elemental iron as iron sucrose in water for injection. Venofer^® contains no preservatives—any unused solution should be discarded. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to infusion.¹

Intravenous Injection
Venofer^® may be administered via the dialysis line as an undiluted solution at a rate of 20 mg of iron per minute not exceeding 100 mg iron per injection.¹

Syringe Stability
Venofer^® when diluted with 0.9% Sodium Chloride Injection, USP, at concentrations ranging from 2 mg to 10 mg of elemental iron per mL, or undiluted (20 mg elemental iron per mL) and stored in a plastic syringe, was found to be physically and chemically stable for 48 hours at controlled room temperature (25°C ± 2°C) and under refrigeration (4°C ± 2°C).²

Intravenous Infusion
Venofer^® may be administered by IV infusion. The content of each vial must be diluted exclusively in a maximum of 100 mL of 0.9% Sodium Chloride Injection, USP.

Do not mix Venofer^® with other medications or add to parenteral nutrition solutions for intravenous infusion.¹

IV Admixture Stability
Venofer^®, when added to IV infusion bags (PVC) containing 0.9% Sodium Chloride Injection, USP, at concentrations ranging from 0.5 mg to 2 mg of elemental iron per mL, has been found to be physically and chemically stable for 48 hours at controlled room temperature (25°C ± 2°C) and under refrigeration (4°C ± 2°C).²

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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