DESCRIPTION
Venofer® (iron sucrose injection, USP) is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use.
Venofer® is supplied in 5 mL and 10 mL single dose vials. Each 5 mL vial contains 100 mg elemental iron (20 mg/mL) and each 10 mL vial contains 200 mg elemental iron (20 mg/mL). Contains no preservatives. Store in original carton at 25°C (77°F). Excursions permitted to 15°-30°C (59°-86°F). Do not freeze.
DOSAGE AND ADMINISTRATION
The dosage of Venofer® is expressed in terms of mg of elemental iron. Each mL contains 20 mg of elemental iron. Most CKD patients will require a minimum cumulative repletion dose of 1,000 mg of elemental iron, administered over sequential sessions, to achieve a favorable hemoglobin response and to replenish iron stores (ferritin, TSAT). Hemodialysis patients may continue to require therapy with Venofer® or other intravenous iron preparations at the lowest dose necessary to maintain target levels of hemoglobin, and laboratory parameters of iron storage within acceptable limits. Administration: Venofer® must only be administered intravenously either by slow injection or by infusion.
Recommended Adult Dosage:
Hemodialysis Dependent-Chronic Kidney Disease Patients (HDD-CKD):
Venofer® may be administered undiluted as a 100 mg slow intravenous injection over 2 to 5 minutes or as an infusion of 100 mg, diluted in a maximum of 100 mL of 0.9% NaCl over a period of at least 15 minutes per consecutive hemodialysis session for a total cumulative dose of 1,000 mg.
Non-Dialysis Dependent-Chronic Kidney Disease Patients (NDD-CKD):
Venofer® is administered as a total cumulative dose of 1,000 mg over a 14 day period as a 200 mg slow IV injection undiluted over 2 to 5 minutes on 5 different occasions within the 14 day period. There is limited experience with administration of an infusion of 500 mg of Venofer®, diluted in a maximum of 250 mL of 0.9% NaCl, over a period of 3.5 to 4 hours on day 1 and day 14; hypotension occurred in 2 of 30 patients treated.
Peritoneal Dialysis Dependent-Chronic Kidney Disease Patients (PDD-CKD):
Venofer® is administered as a total cumulative dose of 1,000 mg in 3 divided doses, given by slow intravenous infusion, within a 28 day period: 2 infusions of 300 mg over 1.5 hours 14 days apart followed by one 400 mg infusion over 2.5 hours 14 days later. The Venofer® dose should be diluted in a maximum of 250 mL of 0.9% NaCl.
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 TSAT ≥50%
Iron therapy should be withheld in patients with ferritin values ≥800 ng/mL. Since transferrin saturation values increase rapidly after IV administration of iron sucrose, serum iron values may be reliably obtained 48 hours after IV iron sucrose dosing .
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.
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).
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).
Reference:
Source: http://venofer.com/VenoferHCP/Venofer_pharmacySpecs.asp
1) Venofer® [package insert]. Shirley, NY: American Regent, Inc.; 2005.
2) Data on file. American Regent, Inc., Shirley, NY
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