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

The dose of Venofer^® (iron sucrose injection, USP) is expressed in terms of milligrams (mg) of elemental iron. Each milliliter (mL) contains 20 mg of elemental iron.

The recommended dose for the replenishment of iron deficiency in hemodialysis patients is 5 mL of Venofer^® (100 mg of elemental iron) delivered intravenously during the dialysis session. Most patients need a minimum cumulative dose of 1000 mg of elemental iron, administered over 10 sequential dialysis sessions, to achieve a favorable hemoglobin or hematocrit response. Patients may continue to require therapy with Venofer^® or other intravenous iron preparations at the lowest dose necessary to maintain target levels.

Venofer^® must be given only intravenously either by slow injection or by infusion.

In chronic renal failure patients on hemodialysis, Venofer^® (iron sucrose injection, USP) may be given undiluted by slow intravenous injection into the dialysis line at a rate of 1 mL (20 mg iron) solution per minute (ie, 5 minutes per vial) not exceeding one vial Venofer^® (100 mg iron) per injection.

Venofer^® also may be given by infusion (into the dialysis line for hemodialysis patients). The content of each vial must be diluted exclusively in a maximum of 100 mL of 0.9% Sodium Chloride, immediately before infusion. The solution should be infused at a rate of 100 mg of iron over a period of at least 15 minutes. Any unused diluted solution should be discarded. Each vial is for single dosing only.

Recommended Dosage
Adults: 100 mg iron given one to three times per week for a total dose of 1000 mg in 10 doses, repeated if needed. The frequency of dosing should be no more than three times weekly. Patients may continue to need therapy with intravenous iron at the lowest dose necessary to maintain levels of hemoglobin, hematocrit, and laboratory parameters of iron storage within acceptable limits.

How Supplied
Venofer^® (iron sucrose injection, USP) is supplied in 5-mL single-dose vials. Each 5-mL vial contains 100 mg elemental iron (20 mg/mL). Venofer^® does not contain dextran or preservatives. Store in original carton at 25°C (77°F). Do not freeze.

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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