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IV iron

Ferric derisomaltose

Brand names: Monofer

Ferric derisomaltose is a parenteral (intravenous) iron preparation used to treat iron-deficiency anaemia when oral iron is ineffective, not tolerated 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: Iron deficiency anaemia (US Monoferric label §2.1): patients weighing 50 kg or more — 1,000 mg of iron by intravenous infusion over at least 20 minutes as a single dose. Patients weighing less than 50 kg — 20 mg/kg actual body weight by intravenous infusion over at least 20 minutes as a single dose. 'Repeat dose if iron deficiency anemia reoccurs.'
Route: Intravenous infusion. 'Withdraw the appropriate volume of Monoferric and dilute in 100 mL to 500 mL of 0.9% Sodium Chloride Injection, USP. Final diluted concentration should be more than 1 mg iron/mL... Administer the prepared solution via intravenous infusion over at least 20 minutes.' The dosage is expressed in mg of elemental iron; each mL of the undiluted product contains 100 mg of elemental iron (vials of 100 mg/1 mL, 500 mg/5 mL and 1,000 mg/10 mL).
Frequency: Single dose, repeated if iron deficiency anaemia reoccurs
Max: Maximum recommended human dose (MRHD) 1,000 mg of iron — the US label refers to 'the maximum recommended human dose (MRHD) of 1000 mg'
⚠️ TWO DIFFERENT PRODUCTS. The dose above is from the US Monoferric label (100 mg iron/mL), which matches the high-dose single-infusion regimen this page describes. The UK SPC fetched in this bundle is for DIAFER 50 mg/ml, a different presentation with a far lower ceiling — verbatim §4.2: 'Diafer may be administered as an up to 200 mg dosage with a maximum weekly administration of 1000 mg. If higher doses than 200 mg of iron are needed, other iron medicinal products intended for intravenous use should be used.' Diafer's route also differs: 'Diafer can be administered either as an intravenous bolus injection or during a haemodialysis session directly into the venous limb of the dialyser. It may be administered undiluted or diluted in up to 20 ml sterile 0.9% sodium chloride.' Do not apply Diafer's 200 mg per-dose limit to Monofer/Monoferric, or the 1,000 mg single dose to Diafer. INDIVIDUALISATION (Diafer SPC §4.2, applies to IV iron generally): 'The iron dose must be individualised based on the clinical response to treatment including evaluation of haemoglobin, ferritin and transferrin saturation, concomitant treatment with an erythropoiesis stimulating agent (ESA) and the dose of ESA treatment. Targets may vary from patient to patient and depending on local guidelines.' ADMINISTRATION SAFETY (both labels): give only where staff trained to evaluate and manage anaphylactic reactions are immediately available and full resuscitation facilities can be assured; observe the patient for at least 30 minutes after each administration. Do not give concomitantly with oral iron preparations, 'since the absorption of oral iron might be decreased'. Compatibility with other drugs has not been established — do not mix with or add to solutions containing other drugs. After dilution in 0.9% sodium chloride the solution may be stored at room temperature for up to 8 hours. Extravasation may cause long-lasting brown discolouration at the site — monitor for it and stop the infusion at that site immediately if it occurs. Each vial is single-dose only; discard the unused portion.

Dose adjustments

Renal

No renal dose adjustment is stated in either label. The UK Diafer SPC covers dialysis administration — 'Diafer can be administered either as an intravenous bolus injection or during a haemodialysis session directly into the venous limb of the dialyser' — and its dosing is individualised on haemoglobin, ferritin, transferrin saturation and concomitant ESA dose rather than on renal function. The US Monoferric label contains no renal-impairment dosing section in any fetched part.

Hepatic

No dose adjustment is stated, but there are explicit restrictions (Diafer SPC): decompensated liver disease is a contraindication (§4.3); and §4.4, verbatim: 'In patients with liver dysfunction, parenteral iron should only be administered after careful benefit/risk assessment. Parenteral iron administration should be avoided in patients with hepatic dysfunction (alanine aminotransferase and/or aspartate aminotransferase > 3 times upper limit of normal) where iron overload is a precipitating factor, in particular Porphyria Cutanea Tarda (PCT).'

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

  • Non-iron deficiency anaemia, e.g. haemolytic anaemia (Diafer SPC §4.3)
  • Iron overload or disturbances in utilisation of iron, e.g. haemochromatosis, haemosiderosis (Diafer SPC §4.3); the US label adds 'Iron Overload: Do not administer Monoferric to patients with iron overload' (§5.2)
  • Hypersensitivity to the active substance, to the product or to any of its excipients (both labels); the US label states it is 'contraindicated in patients with a history of serious hypersensitivity to Monoferric or any of its components. Reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse'
  • Known serious hypersensitivity to other parenteral iron products (Diafer SPC §4.3)
  • Decompensated liver disease (Diafer SPC §4.3)
  • Not a contraindication but an exclusion (Diafer SPC §4.4): 'Diafer should not be used in patients with ongoing bacteraemia'; parenteral iron should be used with caution in acute or chronic infection

Side effects

  • US label §6: 'Most commonly reported adverse reactions (incidence ≥1%) are rash and nausea'
  • Acute, severe hypersensitivity reactions (Diafer SPC §4.8): 'They usually occur within the first few minutes of administration and are generally characterised by the sudden onset of respiratory difficulty and / or cardiovascular collapse; fatalities have been reported.' Serious hypersensitivity, including anaphylactic-type reactions, some life-threatening and fatal, are also reported in the US label; in clinical trials in iron deficiency anaemia and CKD, serious or severe hypersensitivity occurred in 0.3% (6/2008) of treated subjects
  • Fishbane reaction (uncommon) — 'flushing in the face, acute chest and/or back pain and tightness sometimes with dyspnea'; may mimic the early symptoms of an anaphylactoid/anaphylactic reaction. Stop the infusion and assess vital signs; symptoms disappear shortly after stopping and typically do not recur if restarted at a lower infusion rate
  • Common (≥1/100 to <1/10), Diafer SPC: nausea, vomiting, abdominal pain, constipation, dyspepsia; flushing, pruritus, rash, urticaria; muscle spasm, back pain; injection site reactions (erythema, swelling, burning, pain, bruising, discolouration, extravasation, irritation)
  • Uncommon (≥1/1,000 to <1/100): hypersensitivity including severe reactions; blurred vision, hypoaesthesia, dysphonia, dysgeusia; arrhythmia, tachycardia; hypotension; dyspnoea, bronchospasm; diarrhoea; angioedema, sweating; myalgia, arthralgia; feeling hot, pyrexia, soreness, inflammation near the injection site, local phlebitic reaction; the Fishbane reaction
  • Rare / very rare / not known: anaphylactoid and anaphylactic reactions; haemolysis; loss of consciousness, seizure, dizziness, restlessness, tremor, fatigue, altered mental status; headache, paraesthesia; transient deafness; foetal bradycardia, palpitations; Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction); hypertension; chest pain; skin discolouration; malaise; influenza-like illness (onset from a few hours to several days)
  • Delayed reactions may also occur with parenteral iron preparations and can be severe (Diafer SPC §4.8; the section was truncated at the source-fetch limit)

Monitoring

  • Observe every patient for at least 30 minutes after each administration — Diafer SPC §4.2: 'The patient should be observed for adverse effects for at least 30 minutes following each Diafer injection'; US label §5.1: 'Monitor patients for signs and symptoms of hypersensitivity during and after Monoferric administration for at least 30 minutes and until clinically stable following completion of the infusion'
  • Administer only where 'staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilities can be assured', with an injectable 1:1000 adrenaline solution available; stop the treatment immediately if hypersensitivity or signs of intolerance occur
  • Iron status — haemoglobin, ferritin and transferrin saturation guide the individualised dose (Diafer SPC §4.2); 'Careful monitoring of iron status is recommended to avoid iron overload' (§4.4)
  • Watch the cannula site: 'Caution should be exercised to avoid paravenous leakage... In case of paravenous leakage, the administration of Diafer must be stopped immediately'; the US label likewise says 'Monitor for extravasation. If extravasation occurs, discontinue the Monoferric administration at that site'
  • Blood pressure — 'Hypotensive episodes may occur if intravenous injection is administered too rapidly' (Diafer SPC §4.4)
  • In pregnancy: 'The unborn baby should be carefully monitored during intravenous administration of parenteral irons to pregnant women' (Diafer SPC §4.6)

Clinical monograph

How it works

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

Prescribing in practice

  • Serious hypersensitivity and anaphylactic reactions can occur, so it must be given where resuscitation facilities are available and the patient observed during and after administration.
  • Avoid in the first trimester of pregnancy and use parenteral iron in later pregnancy only when clearly necessary.
  • Extravasation can cause persistent brown skin staining, so infusion site care is important.

Monitoring

Monitor the patient closely for hypersensitivity during and after the infusion and reassess iron indices and haemoglobin to gauge response.

Counselling the patient

  • Report any rash, breathlessness, swelling or feeling unwell during or after the infusion immediately.
  • Tell the team about any previous reactions to intravenous iron.
  • Some people experience temporary symptoms such as headache or altered taste.

Evidence & guidelines

Intravenous iron is recommended where oral iron is unsuitable or replacement must be rapid, consistent with NICE and MHRA advice on managing iron-deficiency anaemia and parenteral iron safety.

Reference: NICE NG8; 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.

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