Heart Failure Pregnancy: Limited data in pregnant women — a careful benefit/risk evaluation is required and the product should not be used during pregnancy unless clearly necessary. Iron deficiency in the first trimester can in many cases be treated with oral iron; treatment should be confined to the second and third trimesters if the benefit outweighs the potential risk. Foetal bradycardia may occur — monitor the unborn baby during intravenous administration. Breast-feeding: transfer of iron to human milk was negligible (≤1%) and a risk to the breast-fed child is unlikely.

Ferric Carboxymaltose

Brand names: Ferinject

Used in: Anaemia

Ferric carboxymaltose is an intravenous iron preparation used to treat iron deficiency, including in heart failure and where oral iron is not tolerated, is ineffective, or rapid replacement 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 determined from SPC Table 1 by haemoglobin and body weight: Hb <10 g/dL (<6.2 mmol/L) — 1,500 mg (35 kg to <70 kg) or 2,000 mg (70 kg and above); Hb 10 to <14 g/dL (6.2 to <8.7 mmol/L) — 1,000 mg (35 kg to <70 kg) or 1,500 mg (70 kg and above); Hb ≥14 g/dL (≥8.7 mmol/L) — 500 mg at either weight. For patients below 35 kg the total iron need is 30 mg/kg body weight (Hb <10 g/dL) or 15 mg/kg body weight (Hb ≥10 g/dL). Two doses may be required to replenish the total iron need.

Route: Intravenous only — by injection (undiluted), by infusion (diluted in sterile 0.9% sodium chloride only), or undiluted directly into the venous limb of the dialyser during a haemodialysis session. Must not be given by the subcutaneous or intramuscular route.

Frequency: Single administration; where the total iron need exceeds the maximum single dose, give the additional dose a minimum of 7 days after the first. Re-assess Hb no earlier than 4 weeks after the final administration and recalculate the iron need if further repletion is required.

Max: Adults and adolescents aged 14 years and older: a single administration must not exceed 15 mg iron/kg body weight (intravenous injection) or 20 mg iron/kg body weight (intravenous infusion), and must not exceed 1,000 mg of iron (20 mL). Maximum recommended cumulative dose 1,000 mg iron per week. In haemodialysis-dependent chronic kidney disease, a single maximum daily dose of 200 mg iron must not be exceeded.

HEART-FAILURE CAVEAT: this page is ferric carboxymaltose in a cardiac context, but the fetched UK SPC (Ferinject 50 mg iron/mL) contains NO heart-failure-specific regimen — dosing is by the iron-need table above. The US label in the same bundle (Injectafer) does carry a separate dosing table for iron deficiency with heart failure (NYHA class II/III), but the fetched text of that table is garbled and incomplete, so it has NOT been transcribed here; a clinician must source the heart-failure regimen from the full label or a heart-failure guideline. Administration rates — intravenous injection: 2 to 4 mL (100 to 200 mg) no minimum prescribed time; >4 to 10 mL (>200 to 500 mg) at 100 mg iron/min; >10 to 20 mL (>500 to 1,000 mg) over 15 minutes. Intravenous infusion (dilute in 0.9% sodium chloride only): 2 to 4 mL (100 to 200 mg) in max 50 mL, no minimum time; >4 to 10 mL (>200 to 500 mg) in max 100 mL over at least 6 minutes; >10 to 20 mL (>500 to 1,000 mg) in max 250 mL over at least 15 minutes. For stability, do not dilute to less than 2 mg iron/mL. Observe the patient for at least 30 minutes after each administration; only administer where staff trained to manage anaphylactic reactions and full resuscitation facilities are available. Monitor serum phosphate in patients receiving multiple or higher doses, long-term treatment, or with risk factors for hypophosphataemia (symptomatic hypophosphataemia leading to osteomalacia and fractures has been reported). PAEDIATRIC (from the same SPC, not carried into paedDose because no single clean per-kg therapeutic dose is stated): children and adolescents aged 1 to 13 years — a single administration must not exceed 15 mg iron/kg body weight and must not exceed 750 mg of iron (15 mL); maximum recommended cumulative dose 750 mg iron per week; additional doses a minimum of 7 days apart; total iron need for patients below 35 kg is 30 mg/kg (Hb <10 g/dL) or 15 mg/kg (Hb ≥10 g/dL). Not recommended below 1 year of age (efficacy and safety not investigated). Not recommended in children aged 1 to 13 years with chronic kidney disease requiring haemodialysis. Verify all paediatric dosing against a children's formulary. Source: eMC SPC for Ferinject 50 mg iron/mL dispersion for injection/infusion (§4.2).

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 must not be exceeded; no safety data are available for single doses above 200 mg iron in this group. Not recommended in children aged 1 to 13 years with chronic kidney disease requiring haemodialysis.

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.

US labelling (FDA)

Reference — US labelling, may differ from UK

For patients weighing 50 kg or more, the recommended dosage is Injectafer 750 mg intravenously in two doses separated by at least 7 days for a total cumulative dose of 1,500 mg of iron per course. For adult patients weighing 50 kg or more, an alternative dose of Injectafer 15 mg/kg body weight up to a maximum of 1,000 mg intravenously may be administered as a single-dose per course. ( 2.1 ) For patients weighing less than 50 kg, the recommended dosage is Injectafer 15 mg/kg body weight intravenously in two doses separated by at least 7 days per course. ( 2.1 ) See Section 2.1, Table 1 for dosage in patients with iron deficiency and heart failure. ( 2.1 ) Injectafer treatment may be repeated …

Source: US FDA prescribing information (openFDA / DailyMed), label dated 2025-01-01. Accessed 2026-06-12. US dosing and indications can differ from UK practice — use UK sources for prescribing decisions.

Contraindications

Hypersensitivity to the active substance, to the product or to 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 (most commonly reported ADR, 3.2%); abdominal pain, vomiting, constipation, diarrhoea, dyspepsia
Injection/infusion site reactions (pain, haematoma, discolouration, extravasation, irritation)
Hypophosphataemia; post-marketing reports of hypophosphataemic osteomalacia and fractures
Headache, dizziness, flushing, hypertension (hypotension and tachycardia uncommon)
Hypersensitivity (uncommon) and anaphylactic reactions (rare, fatalities reported — the most serious ADR); rash, pruritus, urticaria, erythema; arthralgia, myalgia, back pain, muscle spasms

Clinical monograph

How it works

It delivers iron within a carbohydrate complex that is taken up by the reticuloendothelial system and released for incorporation into haemoglobin and replenishment of iron stores, bypassing the limitations of gastrointestinal absorption.

Prescribing in practice

Serious hypersensitivity reactions, including anaphylaxis, can occur — administer only where resuscitation facilities are immediately available and observe the patient during and after the infusion.
Hypophosphataemia can occur and may be significant or prolonged, particularly with repeated dosing — monitor serum phosphate and correct if needed.
Extravasation can cause persistent brown skin staining, so ensure secure venous access; avoid intravenous iron during active infection and use with caution in hepatic impairment.

Monitoring

Observe the patient during and after administration for hypersensitivity. Monitor haematological response (haemoglobin and iron indices) and serum phosphate, especially with repeated courses, and inspect the infusion site for extravasation.

Counselling the patient

Tell us immediately during the infusion if you feel unwell, dizzy, breathless, or develop a rash or swelling.
Report any pain, swelling or skin discolouration at the drip site, as leakage can cause long-lasting brown staining.
Some people feel tired or notice muscle symptoms afterwards; seek advice if these are marked or persistent.

Evidence & guidelines

Intravenous iron is recommended for iron deficiency where oral iron is unsuitable, and is used in selected patients with heart failure (NICE NG106; MHRA guidance on intravenous iron).

Reference: AFFIRM-AHF Lancet 2020; 396(10266):1895-1904; IRONMAN Lancet 2022; 400(10353):2199-2209; ESC HF Guidelines 2021; MHRA 2023 DSU; 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).

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