iron sucrose (Venofer®)
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Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate]
| -- Hemodialysis Dependent-Chronic Kidney Disease Patients: --
[ 100 mg ] [ 100 ml ] [ at least 15 minutes ]
Note: Venofer® may be administered undiluted as a 100 mg slow intravenous injection over 2 to 5 minutes.
------- OTHER INDICATIONS ---------------
Stability / Miscellaneous
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.
Mechanism of Action
INDICATIONS AND USAGE:
DOSAGE AND ADMINISTRATION:
Venofer must only be administered intravenously either by slow injection or by infusion. The dosage of Venofer is expressed in mg of elemental iron. Each mL contains 20 mg of elemental iron.
Adult Patients with Hemodialysis Dependent-Chronic Kidney Disease (HDD-CKD)
Adult Patients with Non-Dialysis Dependent-Chronic Kidney Disease (NDD-CKD)
Adult Patients with Peritoneal Dialysis Dependent-Chronic Kidney Disease (PDD-CKD)
Pediatric Patients (2 years of age and older) with HDD-CKD for iron maintenance treatment
For iron maintenance treatment: Administer Venofer at a dose of 0.5 mg/kg, not to exceed 100 mg per dose, every two weeks for 12 weeks given undiluted by slow intravenous injection over 5 minutes or diluted in 25 mL of 0.9% NaCl and administered over 5 to 60 minutes. Venofer treatment may be repeated if necessary.
Pediatric Patients (2 years of age and older) with NDD-CKD or PDD-CKD who are on erythropoietin therapy for iron maintenance treatment
For iron maintenance treatment: Administer Venofer at a dose of 0.5 mg/kg, not to exceed 100 mg per dose, every four weeks for 12 weeks given undiluted by slow intravenous injection over 5 minutes or diluted in 25 mL of 0.9% NaCl and administered over 5 to 60 minutes. Venofer treatment may be repeated if necessary.
WARNINGS AND PRECAUTIONS
---Hypotension: Venofer may cause hypotension. Monitor for signs and symptoms of hypotension during and following each administration of Venofer.
--Iron Overload: Regularly monitor hematologic responses during Venofer therapy. Do not administer Venofer to patients with iron overload.
To report SUSPECTED ADVERSE REACTIONS, contact American Regent, Inc. at 1-800-734-9236 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DOSAGE FORMS AND STRENGTHS:
10 mL single-use vial / 200 mg elemental iron (20 mg/mL)
Syringe Stability: Venofer, when diluted with 0.9% NaCl 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 7 days 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 or non-PVC) containing 0.9% NaCl at concentrations ranging from 1 mg to 2 mg of elemental iron per mL, has been found to be physically and chemically stable for 7 days at controlled room temperature (25°C ± 2°C).
Do not dilute to concentrations below 1 mg/mL.
Do not mix Venofer with other medications or add to parenteral nutrition solutions for intravenous infusion.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to infusion.