Venofer® – Iron Sucrose

iron sucrose (Venofer®)

Usual Diluents

Standard Dilutions   [Amount of drug] [Infusion volume] [Infusion rate]

Note: Venofer® may be administered undiluted as a 100 mg slow intravenous injection over 2 to 5 minutes.

------- OTHER INDICATIONS ---------------
See text for other dilutions

Stability / Miscellaneous

Mechanism of Action
Venofer is an aqueous complex of poly-nuclear iron (III)-hydroxide in sucrose. Following intravenous administration, Venofer is dissociated into iron and sucrose and the iron is transported as a complex with transferrin to target cells including erythroid precursor cells. The iron in the precursor cells is incorporated into hemoglobin as the cells mature into red blood cells.

Pharmacodynamics
Following intravenous administration, Venofer is dissociated into iron and sucrose. In 22 patients undergoing hemodialysis and receiving erythropoietin (recombinant human erythropoietin) therapy treated with iron sucrose containing 100 mg of iron, three times weekly for three weeks, significant increases in serum iron and serum ferritin and significant decreases in total iron binding capacity occurred four weeks from the initiation of iron sucrose treatment.

INDICATIONS AND USAGE:
Venofer is an iron replacement product indicated for the treatment of iron deficiency anemia in patients with chronic kidney disease (CKD).

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)
Administer Venofer 100 mg undiluted as a 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. Venofer should be administered early during the dialysis session. The usual total treatment course of Venofer is 1000 mg. Venofer treatment may be repeated if iron deficiency reoccurs.

Adult Patients with Non-Dialysis Dependent-Chronic Kidney Disease (NDD-CKD)
Administer Venofer 200 mg undiluted as a slow intravenous injection over 2 to 5 minutes or as an infusion of 200 mg in a maximum of 100 mL of 0.9% NaCl over a period of 15 minutes. Administer on 5 different occasions over a 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. Venofer treatment may be repeated if iron deficiency reoccurs.

Adult Patients with Peritoneal Dialysis Dependent-Chronic Kidney Disease (PDD-CKD)
Administer Venofer in 3 divided doses, given by slow intravenous infusion, within a 28 day period: 2 infusions each of 300 mg over 1.5 hours 14 days apart followed by one 400 mg infusion over 2.5 hours 14 days later. Dilute Venofer in a maximum of 250 mL of 0.9% NaCl. Venofer treatment may be repeated if iron deficiency reoccurs.

Pediatric Patients (2 years of age and older) with HDD-CKD for iron maintenance treatment
The dosing for iron replacement treatment in pediatric patients with HDD-CKD has not been established.

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
The dosing for iron replacement treatment in pediatric patients with NDD-CKD or PDD-CKD has not been established.

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.

CONTRAINDICATIONS:
Known hypersensitivity to Venofer

WARNINGS AND PRECAUTIONS
--Hypersensitivity Reactions: Observe for signs and symptoms of hypersensitivity during and after Venofer administration for at least 30 minutes and until clinically stable following completion of each administration. Only administer Venofer when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions.

---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.

ADVERSE REACTIONS
The most common adverse reactions (>/=2%) following the administration of Venofer are diarrhea, nausea, vomiting, headache, dizziness, hypotension, pruritus, pain in extremity, arthralgia, back pain, muscle cramp, injection site reactions, chest pain, and peripheral edema.

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:
Venofer is supplied sterile in 10 mL, 5 mL, and 2.5 mL single-use vials. Each 10 mL vial contains 200 mg elemental iron, each 5 mL vial contains 100 mg elemental iron, and each 2.5 mL vial contains 50 mg elemental iron (20 mg/mL).

10 mL single-use vial / 200 mg elemental iron (20 mg/mL)
5 mL single-use vial / 100 mg elemental iron (20 mg/mL)
2.5 mL single-use vial / 50 mg elemental iron (20 mg/mL)

Pharmacy Specifications:
Stability and storage
Contains no preservatives. Store in original carton at 20°C to 25°C (68° F to 77° F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Do not freeze.

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.

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 .

Reference:
Source: https://venofer.com/VenoferHCP/Venofer_pharmacySpecs.asp
1) Venofer® [package insert]. Shirley, NY: American Regent, Inc.; 2010.
2) Data on file. American Regent, Inc., Shirley, NY