Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Iron sucrose intravenous

Generic name
Iron sucrose intravenous
Brand name
ATC Code
B03AC

Pharmacokinetics in children

In a study of 11 patients aged 12-16 years, a half-life T½ of 8 hours was observed and a Cmax of 8545 μg/dl.

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

Iron deficiency anaemia
  • Intravenous
    • Premature infants Gestational age < 37 weeks
      • Fe: 3 mg/kg/dose 1-3 times a week.

      • Observation is indicated during every treatment and until at least 30 minutes afterwards due to the risk of severe, acute, potentially lethal anaphylactic or anaphylactoid reactions
Iron deficiency anaemia in chronic renal insufficiency
  • Intravenous
    • ≥ 1 month
      • Fe: 1 - 2 mg/kg per 2 weeks in 1 dose

      • Observation is indicated during every treatment and until at least 30 minutes afterwards due to the risk of severe, acute, potentially lethal anaphylactic or anaphylactoid reactions,

         

    • ≥ 1 month
      [3] [6]
      • Fe: 1 - 2 mg/kg per 2 weeks in 1 dose

      • Observation is indicated during every treatment and until at least 30 minutes afterwards due to the risk of severe, acute, potentially lethal anaphylactic or anaphylactoid reactions,

         
Maintenance iron therapy in haemodialysis
  • Intravenous
    • ≥ 2 years
      • Fe 0.5 mg/kg per 2 weeks in 1 dose

      • Administer at the end of the dialysis
        Observation is indicated during every treatment and until at least 30 minutes afterwards due to the risk of severe, acute, potentially lethal anaphylactic or anaphylactoid reactions.

    • ≥ 2 years
      [4] [5]
      • Fe 0.5 mg/kg per 2 weeks in 1 dose

      • Administer at the end of the dialysis
        Observation is indicated during every treatment and until at least 30 minutes afterwards due to the risk of severe, acute, potentially lethal anaphylactic or anaphylactoid reactions.
Iron deficiency anaemia in haemodialysis
  • Intravenous
    • ≥ 2 years
      [7]
      • Fe: 3 mg/kg/week in 1 dose

      • Administer at the end of the dialysis
        Observation is indicated during every treatment and until at least 30 minutes afterwards due to the risk of severe, acute, potentially lethal anaphylactic or anaphylactoid reactions.

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Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Olfactory disorders, respiratory tract infections, peritonitis and coughs

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Watch out for hypersensitivity reactions, even after earlier use was well tolerated. Late reactions include joint pain and muscle pain.

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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IRON PREPARATIONS
B03AA03
B03AC
B03AA02
B03AA01
B03AA01
B03AA07
B03AA05
B03AB05
B03AB02
B03AB02
VITAMIN B12 AND FOLIC ACID
B03BB01
B03BA03
OTHER ANTIANEMIC PREPARATIONS
B03XA02
B03XA01
B03XA01
B03XA01
B03XA03

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References

  1. Anbu AT, et al, Low incidence of adverse events following 90-minute and 3-minute infusions of intravenous iron sucrose in children on erythropoietin, Acta Paediatr, 2005, Dec;94(12), 1738-41
  2. Crary SE, et al, Intravenous iron sucrose for children with iron deficiency failing to respond to oral iron therapy, Pediatr Blood Cancer, 2011, Apr;56(4), 615-9
  3. Van Damme-Lombaerts R, et al, Erythropoietin treatment in children with renal failure, Pediatr Nephrol, 1999, Feb;13(2), 148-52
  4. Formulary monograph Venofer., Sep 2012
  5. Goldstein SL, et al, Comparison of the safety and efficacy of 3 iron sucrose iron maintenance regimens in children, adolescents, and young adults with CKD: a randomized controlled trial, Am J Kidney Dis, 2013, Apr;61(4), 588-97
  6. KDIGO Anemia Work Group, KDIGO Clinical Practice Guideline for Anemia in Chronic Kidney Disease, Kidney Int Suppl, 2012, 2(4), 279-335
  7. KDOQI; National Kidney Foundation, KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Anemia in Chronic Kidney Disease, Am J Kidney Dis, 2006, May;47(5 Suppl 3), S11-145
  8. Leijn E, et al, Intravenous iron supplementation in children on hemodialysis, J Nephrol, 2004, May-Jun;17(3), 423-6
  9. Meyer MP, et al, A comparison of oral and intravenous iron supplementation in preterm infants receiving recombinant erythropoietin, J Pediatr, 1996, Aug;129(2), 258-63
  10. Michaud L,, Tolerance and efficacy of intravenous iron saccharate for iron deficiency anemia in children and adolescents receiving long-term parenteral nutrition, Clin Nutr, 2002, Oct;21(5), 403-7
  11. Pinsk V,, Efficacy and safety of intravenous iron sucrose therapy in a group of children with iron deficiency anemia, Isr Med Assoc J., 2008, May 10(5), 335-8
  12. Vifor Inc. ., SPC Venofer, www.cbg-meb.nl, Geraadpleegd 23-12-2011
  13. DHPC intraveneuze ijzerprodukten, Verscherpte aanbevelingen met betrekking tot het risico op ernstige overgevoeligheidsreacties bij gebruik van intraveneuze ijzerprodukten, www.cbg-meb.nl, 13 november 2013, Geraadpleegd 13 januari 2014, http://www.cbg-meb.nl/NR/rdonlyres/D43043FD-723A-49F2-B94D-0FF958DE07DE/0/1311DHPCijzerproducten.pdf

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Changes

Changes