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Intravenous Iron Pregnancy: Restricted to the second and third trimesters, and only if clearly necessary. Verbatim UK SPC 4.6: 'There is no data from the use of iron sucrose in pregnant women in the first trimester. Data (303 pregnancy outcomes) from the use of Venofer in pregnant women in the second and third trimester showed no safety concerns for the mother or newborn. A careful risk/benefit evaluation is required before use during pregnancy and Venofer should not be used during pregnancy unless clearly necessary. Iron deficiency anaemia occurring in the first trimester of pregnancy can in many cases be treated with oral iron. Treatment with Venofer should be confined to second and third trimester if the benefit is judged to outweigh the potential risk for both the mother and the foetus. Foetal bradycardia may occur following administration of parenteral irons. It is usually transient and a consequence of a hypersensitivity reaction in the mother. The unborn baby should be carefully monitored during intravenous administration of parenteral irons to pregnant women.' Breast-feeding: limited information on excretion in human milk; in one study of 10 healthy breast-feeding mothers given 100 mg iron as iron sucrose, the iron content of breast milk had not increased four days after treatment and did not differ from the control group (n=5); exposure of the infant cannot be excluded, so the risk/benefit should be assessed. Fertility: 'No effects of iron sucrose treatment were observed on fertility and mating performance in rats.'

Iron Sucrose (Venofer) 100–200mg IV

Brand names: Venofer

Iron sucrose (Venofer) is an intravenous iron preparation widely used to treat iron deficiency anaemia in chronic kidney disease, particularly in haemodialysis patients, where oral iron is poorly absorbed or insufficient.

Adult dose

Dose: Iron deficiency — adults: 5 to 10 mL of Venofer (100 to 200 mg iron) 1 to 3 times a week. The cumulative dose must be calculated individually for each patient from the total iron deficit and must not be exceeded: 'Total iron deficit [mg] = BW [kg] x (target Hb - actual Hb) [g/dL] x 2.4 + storage iron [mg]', where below 35 kg body weight target Hb = 13 g/dL and storage iron = 15 mg/kg body weight, and at 35 kg body weight and above target Hb = 15 g/dL and storage iron = 500 mg. If the total necessary dose exceeds the maximum allowed single dose, the administration must be divided.
Route: Intravenous only. 'Venofer must only be administered by the intravenous route. This may be by a slow intravenous injection, by an intravenous drip infusion or directly into the venous line of the dialysis machine.' Slow intravenous injection: at a rate of 1 mL undiluted solution per minute and not exceeding 10 mL Venofer (200 mg iron) per injection. Intravenous drip infusion: diluted only in sterile 0.9% m/V sodium chloride immediately prior to infusion — 50 mg (2.5 mL) in a maximum of 50 mL over a minimum of 8 minutes; 100 mg (5 mL) in a maximum of 100 mL over a minimum of 15 minutes; 200 mg (10 mL) in a maximum of 200 mL over a minimum of 30 minutes. For stability reasons, dilutions to lower Venofer concentrations are not permissible. During haemodialysis, Venofer may be given directly into the venous line of the dialysis machine under the same conditions as for intravenous injection.
Frequency: 1 to 3 times a week
Max: 200 mg iron (10 mL Venofer) per single injection — the label states slow intravenous injection 'not exceeding 10 mL Venofer (200 mg iron) per injection'. The individually calculated cumulative dose must also not be exceeded.
SOURCE IDENTITY — EXACT MATCH. The fetched product is 'Venofer (iron sucrose) 20 mg iron / ml, solution for injection or concentrate for solution for infusion' (UK SPC via eMC, product 5911). || VERBATIM UK SPC 4.2, Posology Adults: '5 - 10 mL of Venofer (100 - 200 mg iron) 1 to 3 times a week.' Calculation of dosage, verbatim: 'The cumulative dose of Venofer must be calculated for each patient individually and must not be exceeded... The dose of Venofer must be individually calculated for each patient according to the total iron deficit calculated with the following Ganzoni formula, for example: Total iron deficit [mg] = BW [kg] x (target Hb - actual Hb) [g/dL] x 2.4* + storage iron [mg]. Below 35 kg BW: Target Hb = 13 g/dL and storage iron = 15 mg/kg BW. 35 kg BW and above: Target Hb = 15 g/dL and storage iron = 500 mg. * Factor 2.4 = 0.0034 (iron content of Hb = 0.34%) x 0.07 (blood volume = 7% of BW) x 1000 (conversion of [g] to [mg]) x 10.' To convert Hb (mM) to Hb (g/dL), multiply the former by 1.6. 'If the total necessary dose exceeds the maximum allowed single dose, then the administration must be divided.' || SCOPE: 4.2 is COMPLETE in this bundle (no truncation marker) — it carries the dosage calculation, the body-weight/Hb dosing table, the adult regimen, the paediatric statement and all three administration routes, so no licensed regimen has been omitted. Section 4.4 IS truncated at the source-fetch limit, cutting off part-way into 4.5 Interactions at 'Venofer should not be administered concomitantly with oral…' — the remainder of the interactions text was NOT retrieved and nothing has been filled in for it. || The only single-dose ceiling this label gives is 200 mg iron (10 mL) per injection. || ADMINISTRATION SAFETY, verbatim 4.2: 'Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of Venofer. Venofer should only be administered when staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilities can be assured. The patient should be observed for adverse effects for at least 30 minutes following each Venofer administration.' || DOSING TABLE (total mL of Venofer at 20 mg iron per mL, by body weight and actual Hb, target Hb 13 g/dL below 35 kg and 15 g/dL at 35 kg and above) — a sample of the label's own table: at 70 kg, 100 mL for Hb 6.0 g/dL, 87.5 mL for Hb 7.5 g/dL, 75 mL for Hb 9.0 g/dL and 62.5 mL for Hb 10.5 g/dL; at 50 kg, 80 / 70 / 60 / 52.5 mL for the same four Hb levels. || Paravenous leakage must be avoided: leakage at the injection site can lead to pain, inflammation and brown discoloration of the skin. Venofer contains up to 7 mg sodium per mL.

Paediatric dose

NO PAEDIATRIC DOSE — the label refuses one. VERBATIM UK SPC 4.2, Paediatric population: 'The use of Venofer has not been adequately studied in children and, therefore, Venofer is not recommended for use in children.' Nothing has been scaled from the adult regimen. If a paediatric IV iron dose is needed, it must come from a source that actually licenses one, and be verified against a children's formulary.

Dose adjustments

Renal

No renal dose adjustment is stated anywhere in the fetched sections — the adult regimen (100 to 200 mg iron, 1 to 3 times a week) and the individually calculated cumulative dose apply irrespective of renal function, and no creatinine-clearance or eGFR threshold appears. What the label does add for dialysis patients is a route: 'Venofer may be administered during a haemodialysis session directly into the venous line of the dialysis machine under the same conditions as for intravenous injection.'

Hepatic

No numeric hepatic adjustment is given, but 4.4 imposes a restriction: 'In patients with liver dysfunction, parenteral iron should only be administered after careful risk/benefit assessment. Parenteral iron administration should be avoided in patients with hepatic dysfunction where iron overload is a precipitating factor, in particular Porphyria Cutanea Tarda (PCT).'

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance, to Venofer or any of its excipients listed in section 6.1
  • Known serious hypersensitivity to other parenteral iron products
  • Anaemia not caused by iron deficiency
  • Evidence of iron overload or hereditary disturbances in utilisation of iron
  • Not a contraindication but a 4.4 restriction: in patients with liver dysfunction, parenteral iron should only be given after careful risk/benefit assessment, and should be avoided in hepatic dysfunction where iron overload is a precipitating factor, in particular Porphyria Cutanea Tarda
  • Not a contraindication but a 4.4 instruction: 'It is recommended that the administration of Venofer is stopped in patients with bacteraemia.' Parenteral iron should be used with caution in acute or chronic infection, with a risk/benefit evaluation in chronic infection
  • Not a contraindication but a 4.4 risk amplifier: the risk of hypersensitivity is enhanced in patients with known allergies including drug allergies, a history of severe asthma, eczema or other atopic allergy, and in patients with immune or inflammatory conditions such as systemic lupus erythematosus and rheumatoid arthritis

Side effects

  • Most commonly reported adverse drug reaction in clinical trials: dysgeusia, 'which occurred with a rate of 4.5 events per 100 subjects'
  • Most important serious adverse drug reactions: hypersensitivity reactions, 'which occurred with a rate of 0.25 events per 100 subjects in clinical trials'. Anaphylactoid/anaphylactic reactions were reported only post-marketing (estimated as rare); fatalities have been reported
  • Common (≥1/100 to <1/10): dysgeusia; hypotension; hypertension; nausea; injection or infusion site reaction (most frequently pain, extravasation, irritation, reaction, discolouration, haematoma, pruritus)
  • Uncommon (≥1/1,000 to <1/100): hypersensitivity; headache, dizziness, paraesthesia, hypoaesthesia; palpitations; flushing, phlebitis; dyspnoea; chromaturia; vomiting, abdominal pain, diarrhoea, constipation; pruritus, rash; muscle spasm, myalgia, arthralgia, pain in extremity, back pain; chills, asthenia, fatigue, peripheral oedema, pain; raised alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase and serum ferritin
  • Rare (≥1/10,000 to <1/1,000): syncope, somnolence; bronchospasm; chest pain, hyperhidrosis, pyrexia; raised blood lactate dehydrogenase
  • Frequency not known: anaphylactoid/anaphylactic reactions, angioedema; depressed level of consciousness, confusional state, loss of consciousness, anxiety, tremor; bradycardia, tachycardia, Kounis syndrome; circulatory collapse, thrombophlebitis; urticaria, erythema; cold sweat, malaise, pallor, influenza-like illness (onset may vary from a few hours to several days)
  • Kounis syndrome — 'acute allergic coronary arteriospasm that can result in myocardial infarction' — has been reported as a progression of hypersensitivity reactions
  • Paravenous leakage at the injection site can lead to pain, inflammation and brown discoloration of the skin

Monitoring

  • Observe the patient for adverse effects for at least 30 minutes following each Venofer administration, and monitor carefully for signs and symptoms of hypersensitivity during and after every administration
  • Give only where staff trained to evaluate and manage anaphylactic reactions are immediately available and full resuscitation facilities can be assured, including an injectable 1:1000 adrenaline solution; additional treatment with antihistamines and/or corticosteroids should be given as appropriate
  • Stop treatment immediately if hypersensitivity reactions or signs of intolerance occur during administration — hypersensitivity has been reported even after previously uneventful doses of parenteral iron complexes including iron sucrose
  • Monitor iron status carefully to avoid iron overload
  • Stop Venofer in patients with bacteraemia; perform a risk/benefit evaluation in chronic infection and use with caution in acute infection
  • Avoid paravenous leakage at the injection site
  • In pregnancy, monitor the unborn baby carefully during intravenous administration — foetal bradycardia may occur following administration of parenteral irons
  • No haemoglobin, ferritin or transferrin-saturation target and no testing interval is stated in the fetched sections; the label's only quantitative targets are the target Hb values used inside the dose calculation (13 g/dL below 35 kg body weight, 15 g/dL at 35 kg and above)

Clinical monograph

How it works

It supplies an iron-sucrose complex that is taken up by the reticuloendothelial system and incorporated into transferrin and ferritin, restoring iron available for haemoglobin synthesis.

Prescribing in practice

  • Give only where staff and equipment to treat anaphylaxis are immediately available, and observe the patient during and after administration for hypersensitivity.
  • Administer by slow intravenous injection or infusion, as rapid administration can cause hypotension.
  • Avoid in the first trimester of pregnancy and use later in pregnancy only when clearly necessary.

Monitoring

Monitor haemoglobin and iron indices to assess response and avoid iron overload, especially with repeated dialysis-unit dosing.

Counselling the patient

  • Tell staff at once about any rash, wheeze, dizziness or facial swelling during the injection.
  • Skin can stain if the drug leaks at the injection site, so report pain or burning there.
  • Several doses may be required to fully replenish your iron stores.

Evidence & guidelines

Renal anaemia guidance supports intravenous iron such as iron sucrose as first-line iron replacement in haemodialysis-dependent CKD.

Reference: KDIGO Anaemia in CKD Guidelines 2012; Venofer SPC; NICE NG203; 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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