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

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

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

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

 

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 IV iron products.  Hypotension has been reported frequently in hemodialysis dependent-CKD patients receiving IV iron, and has also been reported in non-dialysis dependent and peritoneal dialysis dependent-CKD patients receiving IV iron.  Hypotension following administration of Venofer^® may be related to rate of administration and total dose delivered.

In multi-dose efficacy studies in hemodialysis dependent-CKD patients (N=231), the most frequent adverse events (>5%), whether or not related to Venofer^® administration, were hypotension, cramps/leg cramps, nausea, headache, graft complications, vomiting, dizziness, hypertension, chest pain and diarrhea.  In post-marketing safety studies in hemodialysis dependent-CKD patients (N=1051), the most frequent adverse events reported (>1%) were congestive heart failure, sepsis and taste perversion.  In multi-dose efficacy studies in non-dialysis dependent-CKD patients (N=91), the most frequent adverse events (≥5%) whether or not related to Venofer^® administration, were taste disturbance, peripheral edema, diarrhea, constipation, nausea, dizziness, and hypertension.  In the study of peritoneal dialysis dependent-CKD patients (N=75), the most frequent adverse events, whether or not related to Venofer^®, reported by ≥5% of these patients were diarrhea, peritoneal infection, vomiting, hypertension, pharyngitis, peripheral edema and nausea.

Please see Full Prescribing Information.

References

1. Venofer^® [package insert]. Shirley, NY: American Regent, Inc.; 2007.
2. Data on file. American Regent, Inc., Shirley, NY.