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IV Iron Preparation — Iron Deficiency Anaemia in Pregnancy Pregnancy: Limited data in pregnant women. A careful benefit/risk evaluation is required and Ferinject should not be used during pregnancy unless clearly necessary; treatment should be confined to the second and third trimester if the benefit is judged to outweigh the potential risk to mother and foetus (first-trimester iron deficiency can in many cases be treated with oral iron). Foetal bradycardia may occur following parenteral iron — usually transient and secondary to maternal hypersensitivity; monitor the unborn baby carefully during intravenous administration. Animal data suggest iron released from Ferinject can cross the placental barrier and that use during pregnancy may influence skeletal development in the fetus. Breast-feeding: transfer of iron to human milk was negligible (<=1%) and it is unlikely to represent a risk to the breast-fed child.

Ferric Carboxymaltose (IV Iron — Pregnancy)

Brand names: Ferinject

Intravenous ferric carboxymaltose used to treat iron-deficiency anaemia in pregnancy, typically when oral iron is ineffective, not tolerated or a rapid response is needed.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Total iron need is calculated from body weight and haemoglobin (SPC Table 1). Hb <10 g/dL (<6.2 mmol/L): 1,500 mg iron if 35 kg to <70 kg, 2,000 mg if 70 kg and above (30 mg iron/kg body weight if below 35 kg). Hb 10 to <14 g/dL (6.2 to <8.7 mmol/L): 1,000 mg if 35 kg to <70 kg, 1,500 mg if 70 kg and above (15 mg iron/kg if below 35 kg). Hb 14 g/dL and above (>=8.7 mmol/L): 500 mg if 35 kg to <70 kg and 500 mg if 70 kg and above (15 mg iron/kg if below 35 kg). Two doses may be required to replenish the total iron need.
Route: Intravenous only — by injection (undiluted dispersion), by infusion (diluted in sterile 0.9% m/V sodium chloride solution only), or during a haemodialysis session undiluted directly into the venous limb of the dialyser. Must NOT be administered by the subcutaneous or intramuscular route.
Frequency: Given as one or two administrations; if the total iron need exceeds the maximum single dose, the additional dose should be a minimum of 7 days apart from the first. Re-assess Hb no earlier than 4 weeks after the final administration; if further repletion is needed, recalculate the iron need from Step 1.
Max: Adults and adolescents aged 14 years and older: a single administration should not exceed 15 mg iron/kg body weight (intravenous injection) or 20 mg iron/kg body weight (intravenous infusion), and should not exceed 1,000 mg of iron (20 mL). Maximum recommended cumulative dose 1,000 mg of iron (20 mL) per week. In haemodialysis-dependent chronic kidney disease, a single maximum daily dose of 200 mg iron should not be exceeded.
Product: Ferinject 50 mg iron/mL dispersion for injection/infusion (ferric carboxymaltose), UK SPC https://www.medicines.org.uk/emc/product/5910/smpc. Iron deficiency must be confirmed by laboratory tests. PREGNANCY-SPECIFIC (SPC §4.6, the reason this page exists) — there are limited data in pregnant women; a careful benefit/risk evaluation is required and Ferinject should not be used during pregnancy unless clearly necessary. Iron deficiency occurring in the FIRST TRIMESTER can in many cases be treated with oral iron; treatment with Ferinject should be CONFINED TO THE SECOND AND THIRD TRIMESTER if the benefit is judged to outweigh the potential risk for both mother and foetus. Foetal bradycardia may occur following administration of parenteral irons — usually transient and a consequence of a hypersensitivity reaction in the mother; the unborn baby should be carefully monitored during intravenous administration to pregnant women. ADMINISTRATION RATES, intravenous injection (Table 2): 2 to 4 mL (100 to 200 mg iron) — no minimal prescribed time; >4 to 10 mL (>200 to 500 mg) — 100 mg iron/min; >10 to 20 mL (>500 to 1,000 mg) — 15 minutes. INTRAVENOUS INFUSION dilution plan (Table 3, sodium chloride 0.9% only): 2 to 4 mL (100 to 200 mg) in a maximum of 50 mL — no minimal prescribed time; >4 to 10 mL (>200 to 500 mg) in a maximum of 100 mL — minimum 6 minutes; >10 to 20 mL (>500 to 1,000 mg) in a maximum of 250 mL — minimum 15 minutes. For stability reasons Ferinject should not be diluted to concentrations less than 2 mg iron/mL. MONITORING (§4.2): monitor carefully for signs and symptoms of hypersensitivity during and following each administration; administer only when staff trained to evaluate and manage anaphylactic reactions are immediately available, in an environment where full resuscitation facilities can be assured; observe the patient for adverse effects for at least 30 minutes after each administration. PAEDIATRIC (§4.2, stated as CEILINGS not as a recommended dose, and out of scope for this obstetric page — hence paedDose is null): in children and adolescents aged 1 to 13 years a single administration should not exceed 15 mg iron/kg body weight or 750 mg of iron (15 mL), with a maximum recommended cumulative dose of 750 mg of iron per week and any additional dose a minimum of 7 days apart; efficacy and safety have not been investigated in children below 1 year of age and Ferinject is not recommended in that age group. Verify any paediatric use against a children's formulary.

Dose adjustments

Renal

In adults and adolescents aged 14 years and older with haemodialysis-dependent chronic kidney disease, a single maximum daily dose of 200 mg iron should not be exceeded. Not recommended in children aged 1 to 13 years with chronic kidney disease requiring haemodialysis (efficacy and safety not investigated).

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance, to Ferinject or any of its excipients
  • Known serious hypersensitivity to other parenteral iron products
  • Anaemia not attributed to iron deficiency, e.g. other microcytic anaemia
  • Evidence of iron overload or disturbances in the utilisation of iron

Side effects

  • Nausea (common; occurring in 3.2% of subjects — the most commonly reported reaction); abdominal pain, vomiting, constipation, diarrhoea and dyspepsia (uncommon)
  • Injection/infusion site reactions (common) — including pain, haematoma, discolouration, extravasation and irritation
  • Hypophosphataemia (common); hypophosphataemic osteomalacia reported post-marketing
  • Headache and dizziness (common); dysgeusia and paraesthesia (uncommon)
  • Flushing and hypertension (common); hypotension, tachycardia, presyncope, syncope and phlebitis (uncommon)
  • Hypersensitivity (uncommon) and anaphylactic reactions (rare) — the most serious reaction, with fatalities reported; Kounis syndrome reported post-marketing

Clinical monograph

How it works

It delivers a stable iron-carbohydrate complex directly into the circulation, allowing iron to be taken up by the reticuloendothelial system and used for haemoglobin synthesis and replenishment of iron stores.

Prescribing in practice

  • Intravenous iron is generally avoided in the first trimester and should be given where facilities to manage hypersensitivity and anaphylaxis are available, with the patient observed during and after infusion.
  • Ferric carboxymaltose can cause hypophosphataemia, which may be symptomatic or prolonged with repeated dosing, so consider checking phosphate when courses are repeated.
  • Extravasation can cause persistent brown skin staining, so secure venous access and monitor the infusion site.

Monitoring

Monitor for hypersensitivity during and after the infusion and reassess haemoglobin and iron indices after an appropriate interval to confirm response.

Counselling the patient

  • Report any rash, itching, swelling, breathlessness or feeling unwell during or shortly after the infusion.
  • Tell staff immediately of any pain, stinging or swelling at the drip site as leakage can cause lasting skin staining.
  • A blood test will be repeated later to check the anaemia has improved.

Evidence & guidelines

MHRA guidance highlights serious hypersensitivity and hypophosphataemia with intravenous iron, and NICE supports parenteral iron when oral iron is unsuitable in pregnancy.

Reference: NICE NG25; RCOG Iron Deficiency Anaemia in Pregnancy (2015); Ferinject SPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.