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

Interactions
PK
Renal impairment
References

Ferricarboxymaltose

Generic name
Ferricarboxymaltose
Brand name
ATC Code
B03AC

Pharmacokinetics in children

Children ≥14 years:
Vd: 0.04 l/kg
t½: 7-12 hours

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

On-label

Licensed use Licensed use

Registration Status Title

Behandeling van ijzerdeficiëntie:
>14 jaar: op basis van Hb en lichaamsgewicht:

Hb

 < 35 kg 35-70 kg > 70 kg

<10 g/dl OF

< 6,2 mmol/l

 500 mg 1500 mg 2000 mg

10-<14 g/dl

OF

6,2 tot <8,7 mmol/l

 500 mg 1000 mg 1500 mg

> 14 g/dl

OF

> 8,7 mmol/l

 500 mg 500 mg 500 mg

Maximum: .als injectie tot 15 mg Fe/kg per keer of als infusie tot 20 mg Fe/kg per keer met een maximum van 1000 mg Fe; max.1000 mg Fe per week

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Available formulations

Inj.vlst. (overeenkomend met Fe) 50 mg/ml

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Dosages

Iron deficiency anaemia
  • Intravenous
    • ≥ 14 years and < 35 kg
      • Onafhankelijk van Hb: 500 mg/dose, once only. Max: 20mg/kg/dose, but not exceeding 1.000 mg/dose.
    • 1 year up to 18 years and 35 up to 70 kg
      • 15 - 20 mg/kg/dose, once only. Max: 1.000 mg/dose.

      • Depending on the Hb value, the following total dose is required to correct the iron deficiency:

        Hb total dose
        <10 g/dl or <6,2 mmol/l 1.500 mg
        10-<14 g/dl or 6,2-<8,7 mmol/l 1.000 mg
        ≥14 g/dl or ≥8,7 mmol/l 500 mg

        NOTE: Multiple doses spread over several weeks may be required to administer the total dose as listed in the table above.
        Maximum dosage PER WEEK: 1000 mg

    • 1 year up to 18 years and ≥ 70 kg
      • 500 - 1.000 mg/dose, once only. Max: 1.000 mg/week.

      • Depending on the Hb value, the following total dose is required to correct the iron deficiency:

        Hb total dose
        <10 g/dl or <6,2 mmol/l 2.000 mg
        10-<14 g/dl or 6,2-<8,7 mmol/l 1.500 mg
        ≥10 g/dl or ≥8,7 mmol/l 500 mg

        NOTE: Multiple doses spread over several weeks may be required to administer the total dose as listed in the table above.
        Maximum dosage PER WEEK: 1000 mg

    • 1 year up to 18 years and < 35 kg
      • 15 - 20 mg/kg/dose, once only. Max single dose: 500 mg/dose.

      • Depending on the Hb level, the following total dose is required to correct iron deficiency:

        Hb

         

        		 total dose
        <10 g/dL or <6,2 mmol/L 30 mg/kg
        10 - <14 g/dL or 6,2 - <8,7 mmol/L 15 mg/kg
        ≥14 g/dL or ≥8,7 mmol/L 15 mg/kg

        NOTE: Multiple doses spread over several weeks may be required to administer the total dose as listed in the table above.
        Maximum dosage PER WEEK: 
        1-14 jaar: 750 mg
        > 14 jaar: 1000 mg

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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

Adult Side Effects

Vaak (1-10%): hypertensie. Hoofdpijn, duizeligheid. Misselijkheid. Reacties op injectieplaats (zoals pijn, blauwe plekken, huidverkleuring, extravasatie, irritatie). Roodheid in het gezicht. Hypofosfatemie.

Soms (0,1-1%): overgevoeligheid. Tachycardie. Hypotensie. Dyspneu. Braken, dyspepsie, buikpijn, obstipatie, diarree. Spier–, rug– of gewrichtspijn, pijn in ledematen, spierkramp. Paresthesie, smaakverlies. Jeuk, urticaria, erytheem, huiduitslag. Koorts, vermoeidheid, pijn op de borst, rillingen, perifeer oedeem. Stijging ALAT, ASAT, γ-GT, lactaatdehydrogenase en alkalische fosfatase.

Zelden (0,01-0,1%): anafylactoïde reacties. Angio-oedeem, bleke gelaatskleur, gezichtsoedeem. Bronchospasmen. Bewustzijnsverlies, (pre-)syncope. Flebitis. Angst. Flatulentie. Malaise, influenza-achtige verschijnselen.

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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 in adults

  • ijzerstapeling of stoornissen in het ijzerverbruik;
  • anemie die niet wordt veroorzaakt door ijzerdeficiëntie;
  • bekende ernstige overgevoeligheid voor parenterale ijzerpreparaten.

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

Given the high prevalence of post-infusion hypophosphatemia, monitoring of serum phosphate is indicated (Cococcioni L, et al)

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

Alerts And Precautions Adults

Tijdens en tot minimaal 30 minuten na elke toediening is in verband met het risico van ernstige acute, potentieel letale anafylactische/anafylactoïde reacties zorgvuldige observatie aangewezen en dienen faciliteiten voor cardiopulmonaire reanimatie inclusief adrenaline (epinefrine) beschikbaar te zijn. Aanvullende behandeling met antihistaminica en/of corticosteroïden indien nodig geven. Bij de geringste tekenen van een anafylactische reactie de toediening direct staken. Overgevoeligheidsreacties kunnen ook optreden als eerdere toediening geen bijwerkingen veroorzaakte. Er is meer kans op anafylactische reacties bij bekende (geneesmiddelen)allergie, bij een voorgeschiedenis van ernstig astma, eczeem of andere atopische allergie en bij immuun- of inflammatoire aandoeningen (bv. SLE, reumatoïde artritis).

Voorzichtig toepassen bij infecties; therapie tijdelijk stoppen bij acute infectie.

Onmiddellijk de infusie stoppen bij (tekenen van) paraveneus lekken, wegens irritatie en langdurige bruine verkleuring van de huid.

Bij leverdisfunctie moet terughoudend worden behandeld, vooral als belasting met ijzer de aandoening kan verergeren zoals bij porphyria cutanea tarda.

Na repletie regelmatig de ijzerspiegels controleren en zo nodig corrigeren.

Er zijn geen gegevens bekend van enkelvoudige doseringen > 200 mg ijzer bij hemodialyse.

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

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References

  1. Vifor France, SmPC Ferinject (RVG 33865) 06-11-2024, www.geneesmiddeleninformatiebank.nl
  2. Powers JM, Intravenous Ferric Carboxymaltose in Children with Iron Deficiency Anemia Who Respond Poorly to Oral Iron., J Pediatr., 2017, Jan 180, 212-216
  3. Laass MW, Effectiveness and safety of ferric carboxymaltose treatment in children and adolescents with inflammatory bowel disease and other gastrointestinal diseases., BMC Gastroenterol, 2014, 17(14), 184
  4. Tan MLN et al., Retrospective review of effectiveness and safety of intravenous ferric carboxymaltose given to children with iron deficiency anaemia in one UK tertiary centre, Eur J Pediatr, 2017, 176, 1419-1423
  5. Ozsahin H. et al, Intravenous ferric carboxymaltose for iron deficiency anemia or iron deficiency without anemia after poor response to oral iron treatment: Benefits and risks in a cohort of 144 children and adolescents, Pediatr Blood Cancer, 2020, Jul 30:, e28614
  6. Cococcioni L, et al., Ferric carboxymaltose treatment for iron deficiency anemia in children with inflammatory bowel disease: Efficacy and risk of hypophosphatemia., Dig Liver Dis, 2021, S1590-8658(21), 00085-2
  7. Hong MH, et al., Letter to the Editor Ferric carboxymaltose infustions are well tolerated in children under 14 years old, a single-centre experience., J Paediatr Child Health, 2019, 55, 1515-6

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Changes

Changes