Ferrofumarate

Generic name
Ferrofumarate
Brand name
ATC Code
B03AA02
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Ferrofumarate

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

no information

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

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Iron deficiency anaemia
  • Oral
    • 1 month up to 18 years
      [13] [20] [21] [22] [23] [24] [25] [26] [27]
      • Elemental iron (Fe2+)
        Starting dose:  1         mg/kg/day in 1 dose. Max: 60 mg/day. If needed, titrate to 3 mg/kg/day based on the severity of anemia and clinical response.  .
      • Duration of treatment:

        The treatment should be continued until the Hb level is normalized. The therapy should be continued after normalization. The overall duration of the therapy should in principle not exceed three months.

      • 1 mg Fe2+ = 3 mg ferrofumarate

        Administer as much as possible between meals, preferably with drinks or foods containing vitamin C and in any case not combined with milk products.

        The dosage has been reduced adjusted according to the guidelines of the Dutch Society for Hematology (1 mg/kg/day elemental iron (Fe2+)). Based on the upregulation of hepcidin after iron supplementation, evidence in adults suggests that less frequent and lower doses provide better iron absorption in the gut and fewer side effects. Children's hepcidin regulation of iron absorption is completely intact, and most likely exhibits a similar pattern of upregulation to that of adults. In children 12 years of age and older, intermittent administration of 200 mg/dose twice a week can be considered.
Iron supplementation after birth
  • Oral
    • Premature infants weight at birth < 2000 g
      [3] [4] [8] [11] [12] [14] [15] [16] [19] [28]
      • From 2-6 weeks after the birth.
        Elemental iron (Fe2+)
         2 - 3         mg/kg/day in 1 - 3 doses. Max: 5 mg/kg/day.
      • Duration of treatment:

        6-12 months

      • 1 mg Fe2+ = 3 mg ferrofumarate

        • During admission with any type of feeding, after discharge only with breastfeeding or normal infant feeding, not with post-discharge feeding.
        • It is difficult to indicate optimal iron supplementation for premature infants and preterm infants.

         

         

    • Premature infants weight at birth 2000 up to 2500 g
      [3] [4] [8] [11] [12] [14] [15] [16] [19] [28]
      • From 2-6 weeks after birth, only when breastfed, until a corrected age of 6 months.
        Elemental iron (Fe2+):
         2 - 3         mg/kg/day in 1 - 3 doses. Max: 5 mg/kg/day.
        •  1 mg Fe2+ =  3 mg ferrofumarate
        • It is difficult to say what the optimum iron supplementation level is for premature babies and infants.
    • Term neonate and ≥ 2500 g
      [3] [4] [8] [11] [12] [14] [15] [16] [19] [28]
      • In principle, no supplementation is needed. If Hb is < 6.0 mmol/l and ferritin is < 20 μg/l, supplement the Fe on individual indication.
        Elemental iron Fe2+:
         2 - 3         mg/kg/day in 1 - 3 doses. Max: 5 mg/kg/day.
      • Duration of treatment:

        The treatment should be continued until the Hb level is normalized. The therapy should be continued after normalization. The overall duration of the therapy should in principle not exceed three months.

      • 1 mg Fe2+= 3 mg ferrofumarate

        It is difficult to say what the optimum iron supplementation level is for premature babies and infants.

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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

Gastrointestinal disorders such as nausea, vomiting, diarrhoea, constipation, lower abdominal pain, reduced appetite and black discoloration of the faeces. Discoloration of the teeth when the suspension is used.

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

  • Young children are very sensitive to the toxic side effects of iron preparations. Caution should be exercised when combining with dietary or other iron salt supplements because of the risk of possible iron overdose.
  • It is advised that doses be taken divided throughout the day to reduce the risk of stomach upset. Taking should be done between meals if possible to obtain better absorption. Administration preferably 30 minutes before food. This is because food reduces the absorption of iron. The medication should not be combined with dairy products. Absorption is reduced by many substances: antacids, phosphates calcium salts, quinolones, tetracyclines and penicillamine. An interval of 2-3 hours should be maintained between intake of the iron preparation and these medications. Orange juice and vitamin C improve absorption.
  • Discoloration of teeth may occur during treatment with iron salts. According to the literature, this discoloration may disappear on its own after the end of treatment, or it should be removed by using an abrasive toothpaste, possibly removed by a dentist. To prevent discoloration of the teeth, the drops should be diluted well with water and swallowed through a straw.
  • The stool may be discolored black.
  • After normalization of hemoglobin, therapy is continued for two to three months to replenish iron stores.

Interactions

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

IRON PREPARATIONS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Iron bivalent, oral preparations
B03AA01
B03AA07
B03AA05

References

  1. Agostoni C, et al, Enteral nutrient supply for preterm infants: commentary from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition, J Pediatr Gastroenterol Nutr , 2010, 50, 85-91
  2. Teva Nederland BV, SmPC Ferrofumaraat tablets (RVG 33291) 28-06-2023, www.geneesmiddeleninformatiebank.nl
  3. Baker RD, et al, Diagnosis and prevention of iron deficiency and iron-deficiency anemia in infants and young children (0-3 years of age), Pediatrics, 2010, Nov;126(5), 1040-50
  4. Berglund S, et al, Iron supplements reduce the risk of iron deficiency anemia in marginally low birth weight infants, Pediatrics, 2010, Oct;126(4), e874-83
  5. Bhargava S, et al, Clinical inquiries. What is appropriate management of iron deficiency for young children?, J Fam Pract, 2006, Jul;55(7), 629-30
  6. Choudhury P, et al, Rationale of iron dosage and formulations in under three children, http://www.idpas.org/pdf/985Rationale.pdf
  7. Dallman PR, et al, Iron deficiency in infancy and childhood, Am J Clin Nutr, 1980, Jan;33(1), 86-118
  8. Edmond K, et al, Optimal feeding of low-birth-weight infants. Technical review. , World Health Organization, 2006
  9. Grant CC, et al, Policy statement on iron deficiency in pre-school-aged children, J Paediatr Child Health, 2007, Jul-Aug;43(7-8), 513-21
  10. Lafeber HN, et al., Werkboek Enterale en parenterale voeding bij pasgeborenen. (3e druk). , Sectie Neonatologie van de Nederlandse Vereniging voor Kindergeneeskunde,.VU Uitgeverij, Amsterdam., 2012
  11. Long H, et al, Benefits of iron supplementation for low birth weight infants: a systematic review, BMC Pediatr, 2012, Jul 16, 12:99
  12. Mills RJ, et al, Enteral iron supplementation in preterm and low birth weight infants, Cochrane Database Syst Rev, 2012 , Mar 14;3, CD005095
  13. Bouma M. et al, NHG Standaard Anemie (M76), Huisarts Wet , Revisie datum: oktober 2014, Versie 2.1
  14. Oski FA, Iron deficiency in infancy and childhood, N Engl J Med, 1993 , Jul 15;329(3):, 190-3
  15. Teva Nederland BV, SmPC suspensie (RVG 51411) 28-06-2023, www.geneesmiddeleninformatiebank.nl
  16. Rao R, et al, Iron therapy for preterm infants, Clin Perinatol, 2009, Mar;36(1), 27-42
  17. de Souza Queiroz S, et al, Iron deficiency anemia in children, J. pediatr. (Rio J.), 2000, 76 (Supl.3), S298-S304
  18. Wall CR, et al, Milk versus medicine for the treatment of iron deficiency anaemia in hospitalised infants, Arch Dis Child, 2005, Oct;90(10), 1033-8
  19. World Health Organization. . , Iron Deficiency Anaemia Assessment, Prevention and Control. A guide for programme managers, http://whqlibdoc.who.int/hq/2001/WHO_NHD_01.3.pdf
  20. Dors, N. et al, Background information on diseases: iron deficiency anemia, https://hematologienederland.nl/achtergrondinformatie-per-ziektebeeld/, 2019, July
  21. Vifor Pharma., Ferrum Hausmann, Lösung 50 mg Eisen/ml., Available from: https://www.fachinfo.de/suche/fi/005720, 09-2022
  22. von Siebenthal HK, et al, Regulation of iron absorption in infants., Am J Clin Nutr., 2023, 117(3), 607-15
  23. Stoffel NU, et al., Oral iron supplementation in iron-deficient women. How much and how often?, Mol Aspects Med, 2020, 75, 100865
  24. Domellöf M, et al., Iron requirements of infants and toddlers, J Pediatr Gastroenterol Nutr, 2014, 58(1), 119-29
  25. Uyoga MA, et al. , The effect of iron dosing schedules on plasma hepcidin and iron absorption in Kenyan infants. , Am J Clin Nutr., 2020, 112(4), 1132-41
  26. Moretti D, et al., Oral iron supplements increase hepcidin and decrease iron absorption from daily or twice-daily doses in iron-depleted young women, Blood, 2015, 126(17), 1981-9
  27. Wegmüller R, et al, Hepcidin-guided screen-and-treat interventions for young children with iron-deficiency anaemia in The Gambia: an individually randomised, three-arm, double-blind, controlled, proof-of-concept, non-inferiority trial., Lancet Glob Health, 2023, 11(1), e105-e16
  28. Embleton ND, et al. , Enteral Nutrition in Preterm Infants (2022): A Position Paper From the ESPGHAN Committee on Nutrition and Invited Experts., Journal of Pediatric Gastroenterology and Nutrition., 2023, 76(2), 248-68.

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