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Pharmacy & Therapeutics Committee
Iron sucrose (Venofer®)
Guidelines for Use
October 2010
OVERVIEW ALTERNATIVE USAGE AND DOSING
• Iron sucrose (Venofer®) is an intravenous iron supplement used to replete • Use in chemotherapy‐related anemia: The use of intravenous iron
iron stores in patients with chronic kidney disease (CKD) supplementation may decrease red blood cell (RBC) transfusion
• It has been shown to be effective in hemodialysis‐dependent (HDD), requirements greater than oral iron therapy in patients with anemia related
nonhemodialysis‐dependent (NDD), and peritoneal dialysis (PDD) patients to chemotherapy.2
• Intravenous (IV) administration overcomes issues related to oral iron • Higher doses of iron sucrose: Doses of 300 mg given over 2 hours appear to
supplementation be safe and well‐tolerated.3 Doses of 400‐ 500 mg diluted in 250 mL of
o Multiple daily dosing normal saline given in a single infusion over 2‐3 hours on days 1 and 14 has
o Inadequate absorption been studied for iron‐repletion in HDD‐CKD and NDD‐CKD patients.4,5
o Gastrointestinal side effects (nausea, constipation) Adverse events were more common at higher doses. Hypotension may be
• Its use is favored to other IV formulations such as iron dextran due to a more frequent in patients receiving larger doses during hemodialysis.
decreased incidence of hypersensitivity reaction Higher doses of iron sucrose may be better tolerated in patients not on
o Administration of a test dose of iron sucrose is not required1 hemodialysis.4,5
• Not indicated for total dose infusions CONTRAINDICATIONS
• ALL PATIENTS ON ERYTHROPOIETIN THERAPY SHOULD BE GIVEN • Iron overload
SUPPLEMENTAL IRON • Known hypersensitivity to any component of the formulation
FDA‐APPROVED USES • Anemia not caused by iron deficiency
• Iron deficiency anemia WARNINGS
o All NDD‐CKD patients • Hypersensitivity reaction
o HDD‐CKD patients receiving concurrent erythropoietin therapy o Monitor for signs and symptoms of an allergic reaction during infusion
o PDD‐CKD patients receiving concurrent erythropoietin therapy o Patients with pre‐existing immune‐mediated diseases may be at
FDA‐APPROVED DOSING increased risk
• Total cumulative iron dose of 1,000 mg is generally sufficient to replete iron • Hypotension
stores in patients with CKD o May be related to the rate of administration and total amount of drug
• HDD‐CKD1 administered
o 100 mg undiluted injection, given over 2‐5 minutes OR P&T GUIDELINES FOR USE
o 100 mg in 100 mL of normal saline, given over 15 minutes • Iron sucrose should only be used in the following patient populations:
o Give with each hemodialysis session until total cumulative iron dose is o Patients with iron deficiency anemia due to CKD
met o Patients with chemotherapy‐induced anemia
• NDD‐CKD1 o Patients with active bleeding who refuse blood transfusion
o 200 mg undiluted injection, given over 2‐5 minutes P&T RESTRICTIONS
o Give total cumulative iron dose in 5 separate administrations within As of October 2010, the use of iron sucrose is no longer restricted.
14 day period
Table 1: Comparison of IV iron products
Formulation Concentration Advantages Disadvantages Incidence of Reported hypersensitivity In‐patient cost
of elemental adverse events6 (per 1 million doses)6
iron
Can be administered to iron
dextran‐sensitive patients6 Free‐iron toxicity: nausea, vomiting,
flushing, and hypotension with rapid
$40.57/100 mg
Decreased risk of free iron or large dose administration
Iron sucrose
20 mg/mL remaining in circulation Up to 36% 2.6
(Venofer®)
No total dose iron replacement‐ must
Larger doses (200‐300 mg) be given 1‐3 times per week
given over 2 hours appear to
be well tolerated3,5
Free‐iron toxicity: nausea, vomiting,
flushing, and hypotension with rapid
or large dose administration
Can be administered to iron
Sodium ferric Increased free iron in circulation due $43.52/125 mg
dextran‐sensitive patients6
gluconate 12.5 mg/mL to rapid release of iron from gluconate Up to 35% 3.3
(Ferrlecit®) complex6
No total dose iron replacement‐ given
over 8 separate dialysis sessions
Only IV iron product approved
Highest rate of adverse events,
for total dose infusion
including hypersensitivity reactions
8.7* Dexferrum®:
Can be given IM $21.50/100 mg
Iron dextran Hypersensitivity reaction caused by
*Adverse events are more
(Dexferrum®, 50 mg/mL antigenicity of dextran component Up to 50%
Adverse events are not related common with high‐ INFeD®: $23.02/100
Infed®)
to the rate of administration‐ molecular weight iron mg
Requires administration of a 25 mg
iron dextran complex dextran (Dexferrum®)
test dose
dissociates slowly
References
1. Venofer® package insert. American regent; last revision 10/08.
2. Dangsuwan P, Manchana T. Blood transfusion reduction with intravenous iron in gynecologic cancer patients receiving chemotherapy. Gynecologic Oncology 2010; 116: 522‐525.
3. Hollands J, Foote E, Rodriguez A. Safety of high‐dose iron sucrose infusion in hospitalized patients with chronic kidney disease. Am J Health‐Syst Pharm 2006;63:731‐735.
4. Chandler G, Harchowel J, Macdougall I. Intravenous iron sucrose: establishing a safe dose. Am J Kid Dis 2001; 38 988‐991.
5. Blaustein D et al. The safety and efficacy of an accelerated iron sucrose dosing regimen in patients with chronic kidney disease. Kid Inter 2003;64:S72‐S77.
6. Silverstein S, Rodgers G. Parenteral iron therapy options. Am J Hematol 2004;76:74‐78.
7. Sinha S, Chiu D, Kolakkat S. Comparison of intravenous iron sucrose versus low‐molecular‐weight iron dextran in chronic kidney disease. J Renal Care 2009;35:67‐73.