Iron Sucrose

Class: Iron Preparations
Chemical Name: iron saccharate
CAS Number: 8047-67-4
Brands: Venofer

Introduction

Hematinic agent; a polynuclear iron (III)-hydroxide sucrose complex.

Uses for Iron Sucrose

Iron Deficiency Anemia in Hemodialysis Patients Receiving Epoetin Alfa Therapy

Treatment of iron deficiency anemia in hemodialysis patients receiving epoetin alfa therapy.^{1 2 3 4 5 6 9 11 12} National Kidney Foundation Dialysis Outcomes Quality Initiative (NKF-DOQI) guidelines recommend regular use of IV iron to prevent functional (and absolute) iron deficiency and improve erythropoiesis in most hemodialysis patients receiving epoetin alfa therapy.⁶

Available data suggest that iron sucrose and sodium ferric gluconate may be associated less frequently with serious adverse effects (e.g., hypersensitivity reactions) than iron dextran.^{4 9 15 16}

Iron Sucrose Dosage and Administration

General

• 
  

  Goal of iron therapy in patients with chronic renal failure is to achieve and maintain a transferrin saturation (TSAT) of at least 20% and a serum ferritin concentration of at least 100 ng/mL.⁶

  
  


• 
  

  Monitor maintenance iron status by measuring TSAT and serum ferritin concentration every 3 months.⁶

  
  


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  Some clinicians have administered test doses in patients with history of allergic reactions to iron dextran.^{10 11 12} (See Sensitivity Reactions under Cautions.)

  
  


• 
  

  Iron sucrose should be administered by personnel trained to provide emergency treatment and who have immediate access to appropriate agents for the treatment of a severe allergic or anaphylactic reaction.⁶

  
  

Administration

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer (diluted) by IV infusion or (undiluted) by slow IV injection directly into the dialysis line.¹

Administer 1–3 times weekly; do not administer more frequently.¹

Any unused portion of the diluted or opened undiluted iron sucrose solution should be discarded.¹

Dilution

When given by IV infusion, the contents of each 100-mg vial must be diluted immediately prior to use in a maximum of 100 mL of 0.9% sodium chloride injection.¹

Rate of Administration

Slow IV injection: Administer undiluted drug at ≤20 mg/minute to minimize risk of hypotension.^{1 3} (See Cardiovascular Effects under Cautions.)

IV infusion: Administer diluted drug over a period of at least 15 minutes.¹

Dosage

Dosage expressed in terms of mg of elemental iron.¹ Iron sucrose injection contains the equivalent of 20 mg of elemental iron per mL.¹

Adults

Iron Deficiency Anemia in Hemodialysis Patients Receiving Epoetin Alfa Therapy

IV

Test dose (given according to clinician discretion): Generally 50 mg of iron sucrose diluted in 50 mL of 0.9% sodium chloride injection and administered over 3–10 minutes;¹ alternatively, 20–25 mg of iron sucrose diluted in 100 mL of 0.9% sodium chloride injection and administered over 30–60 minutes.^{10 11 12}

Therapeutic dose: 100 mg 1–3 times weekly.¹ Most patients require minimum cumulative dose of 1 g of elemental iron, administered over 10 sessions at or during sequential dialysis treatments, to achieve a favorable hemoglobin/hematocrit response.^{1 2 3 6}

Courses of iron sucrose therapy may be repeated.^{1 6}

Prescribing Limits

Adults

Iron Deficiency Anemia in Hemodialysis Patients Receiving Epoetin Alfa Therapy

IV

Single doses generally should not exceed 100 mg and frequency of dosing should not exceed 3 times weekly.^{1 6}

Special Populations

Geriatric Patients

Select dosage with caution (usually initiating therapy at relatively low dosage) because of age-related decreases in hepatic, renal, and/or cardiac function and of concomitant disease and/or other drug therapies.¹

Cautions for Iron Sucrose

Contraindications

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  Known hypersensitivity to iron sucrose or any ingredient in the formulation.¹

  
  


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  Evidence of iron overload.¹

  
  


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  Anemias not associated with iron deficiency.¹

  
  

Warnings/Precautions

Warnings

Sensitivity Reactions

Rare, potentially fatal sensitivity reactions, including anaphylactic shock, loss of consciousness, collapse, hypotension, dyspnea, and seizures.^{1 2} Immediate medical intervention and drug discontinuance required in such cases.¹ Clinicians should be vigilant when administering any IV iron preparation.¹

Cardiovascular Effects

Possible hypotension associated with IV administration; may be minimized by adhering to recommended total doses and rates of administration.¹ (See Dosage and Administration.)

General Precautions

Iron Toxicity

Withhold iron administration in patients with evidence suggesting iron overload because body iron excretion is limited and excessive iron in tissues can be hazardous.¹ Periodically monitor laboratory values indicative of iron storage in the body (e.g., transferrin saturation, serum ferritin concentrations) to detect iron accumulation.^{1 6}

Specific Populations

Pregnancy

Category B.¹

Lactation

Not known whether iron sucrose is distributed into milk; use caution in nursing women.¹

Pediatric Use

Safety and efficacy not established in children <18 years of age.¹⁴

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; use caution in dosage selection and adjustment.¹

Concomitant Disease States

Clinical studies generally excluded patients with serious underlying disease, inflammatory conditions, or active infections; use with caution.^{2 3 14}

Common Adverse Effects

Hypotension, cramps/leg cramps, nausea, headache, vomiting, diarrhea.¹

Interactions for Iron Sucrose

Oral Iron Preparations

No formal drug interaction studies to date.¹

Like other parenteral iron preparations, iron sucrose injection may be expected to reduce absorption of concomitantly administered oral iron.¹

Iron Sucrose Pharmacokinetics

Distribution

Extent

Distributed into liver, spleen, and bone marrow.¹

Elimination

Metabolism

Following IV administration, dissociated into iron and sucrose by the reticuloendothelial system.¹

Elimination Route

Sucrose component is eliminated mainly by urinary excretion.¹

Half-life

6 hours.¹

Special Populations

Serum clearance of iron expected to be more rapid in iron-deficient patients than in healthy individuals.¹

Stability

Storage

Parenteral

Injection

25°C (may be exposed to 15–30°C); do not freeze.¹

Contains no preservatives; use immediately after opening vial(s).¹

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Iron sucrose injection should not be mixed with other drugs or added to parenteral nutrition solutions for IV infusion.¹

ActionsActions

• 
  

  Has pharmacologic actions similar to those of other parenteral iron preparations (e.g., iron dextran, sodium ferric gluconate).^{1 4}

  
  


• 
  

  Iron sucrose is free of ferrous ions and dextran polysaccharides, which are believed to be antigenic stimuli for anaphylactic reactions.^{5 7 8}

  
  

Advice to Patients

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  Risk of potentially fatal sensitivity (e.g., anaphylactoid) reactions.^{1 8}

  
  


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  Risk of hypotension.¹

  
  


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  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


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  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.¹

  
  


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  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Iron Sucrose

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection, for IV infusion	equivalent to 20 mg/mL of elemental iron	Venofer	American Regent

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. American Regent Laboratories. Venofer (iron sucrose) injection prescribing information. Shirley, NY; 2000 Dec.

2. Charytan C, Levin N, Al-Saloum M et al. Efficacy and safety of iron sucrose for iron deficiency in patients with dialysis-associated anemia: North American clinical trial. Am J Kidney Dis. 2001; 37:300-7. [IDIS 458970] [PubMed 11157370]

3. Van Wyck DB, Cavallo G, Spinowitz BS et al. Safety and efficacy of iron sucrose in patients sensitive to iron dextran: North American clinical trial. Am J Kidney Dis. 2000; 36:88-97. [IDIS 450865] [PubMed 10873877]

4. Baille GR, Johnson CA, Mason NA. Parenteral iron products for anemia in end-stage renal disease: comparative considerations. Formulary. 2000; 35:498-513.

5. Sunder-Plassmann G, Hörl WH. Safety aspects of parenteral iron in patients with end-stage renal disease. Drug Saf. 1997; 17:241-50. [PubMed 9352960]

6. National Kidney Foundation. NKF/DOQI clinical practice guidelines for anemia of chronic kidney disease: update 2000. Am J Kidney Dis. 2001; 37(Suppl 1): S182-S238.

7. Geisser P, Baer M, Schaub E. Structure/histotoxicity relationship of parenteral iron preparations. Arzneim Forsch. 1992; 42:1439-52.

8. Fishbane S, Kowalski EA. The comparative safety of intravenous iron dextran, iron saccharate, and sodium ferric gluconate. Semin Dial. 2000; 13:381-4. [PubMed 11130261]

9. Health care financing administration. Medicare coverage policy decisions: venofer (iron sucrose injection) (#CAG-00080A) decision memorandum. From the HCFA website: ().

10. Domrongkitchaiporn S, Jirakranont B, Atamasrikul K et al. Indices of iron status in continuous ambulatory peritoneal dialysis patients. Am J Kidney Dis. 1999; 34:29-35. [IDIS 433261] [PubMed 10401012]

11. Silverberg DS, Blum M, Peer G et al. Intravenous ferric saccharate as an iron supplement in dialysis patients. Nephron. 1996; 72:413-7. [PubMed 8852489]

12. Silverberg DS, Iaina A, Peer G et al. Intravenous iron supplementation for the treatment of the anemia of moderate to severe chronic renal failure patients not receiving dialysis. Am J Kidney Dis. 1996; 27:234-8. [IDIS 361247] [PubMed 8659499]

13. Besarab A, Frinak S, Yee S. An indistinct balance: the safety and efficacy of parenteral iron therapy. J Am Soc Nephrol. 1999; 10:2029-43. [PubMed 10477157]

14. American Regent Laboratories, Shirley, NY; Personal communication.

15. Faich G, Strobos J. Sodium ferric gluconate in sucrose: safer intravenous iron therapy than iron dextrans. Am J Kidney Dis. 1999; 33(3): 464-70.

16. Nissenson AR, Lindsay RM, Swan S et al. Sodium ferric gluconate in sucrose is safe and effective in hemodialysis patients: North American clinical trial. Am J Kidney Dis. 1999; 33(3):471-82. [IDIS 424841] [PubMed 10070911]

More Iron Sucrose resources

• Iron Sucrose Side Effects (in more detail)
• Iron Sucrose Use in Pregnancy & Breastfeeding
• Iron Sucrose Drug Interactions
• Iron Sucrose Support Group
• 3 Reviews for Iron Sucrose - Add your own review/rating

• Iron Sucrose Professional Patient Advice (Wolters Kluwer)


• Iron Sucrose MedFacts Consumer Leaflet (Wolters Kluwer)


• Venofer Prescribing Information (FDA)


• Venofer Consumer Overview

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