Information intended for UK healthcare professionals only. 

This formulary decision guide is promotional and was developed from content provided by Norgine Pharmaceuticals Limited in a format developed by Guidelines in Practice. It was commissioned by Norgine Pharmaceuticals Limited, who carried out full medical approval to ensure compliance with regulations (contains promotional information).

View FERACCRU® (ferric maltol) prescribing information and adverse event reporting information here

Key points:

FERACCRU®:

  • is indicated for the treatment of iron deficiency in adults1,2
  • contains the ferric form of iron (Fe3+)1,2
  • is a stable complex—ferric iron is tightly bound to three maltol molecules (a naturally occurring sugar derivative)1–3
  • Unlike oral ferrous (Fe2+) salts, the Fe3+ in FERACCRU® remains tightly bound to maltol until the point of iron absorption.1,2,4,5

View the PDF of this formulary decision guide here

Drug names

FERACCRU® (ferric maltol) 30 mg hard capsules

Indication

  • FERACCRU® is indicated in adults for the treatment of iron deficiency.1,2

British Society of Gastroenterology (BSG) guidelines6

  • Iron deficiency anaemia (IDA):
    • is a common and major cause of morbidity worldwide
    • is the most common form of anaemia seen in primary care in the UK
    • can be caused by poor dietary intake and malabsorption of dietary iron, as well as several significant gastrointestinal (GI) pathologies, for example cancer
    • in adult men and postmenopausal women is often due to chronic blood loss from the GI tract 
  • The BSG guidelines state that the best option for patients with significant intolerance to oral iron replacement therapy (IRT) (usually GI disturbance) is unclear and, depending on the patient, oral ferric maltol, alternate day oral iron and parenteral iron are all options
  • The standard practice of switching to a different traditional iron salt is not supported by evidence
  • Although more expensive than traditional iron salts, ferric maltol is considerably less expensive than parenteral irons
  • For patients with intolerance or failure of haemoglobin (Hb) response at the 2–4 weeks point, alternate day traditional iron salts (if not already used) or ferric maltol may be alternatives to parenteral iron on those with mild-to-moderate anaemia (Hb >95 g/l).

Dosage

  • Each FERACCRU® capsule contains 30 mg iron (as ferric maltol)1,2

  • The recommended dose is one capsule twice daily, morning and evening, on an empty stomach1,2
  • Patients should take FERACCRU® with half a glass of water (one hour before a meal, or at least two hours after a meal)7,8
  • Treatment duration will depend on the severity of iron deficiency, but generally at least 12 weeks treatment is required1,2
  • The treatment should be continued as long as necessary to replenish iron stores, according to blood tests1,2
  • No dose adjustment is needed in elderly patients1,2
  • FERACCRU® has not been studied in patients with impaired renal (eGFR <15 ml/min/1.73 m2) and/or impaired hepatic function.1,2 

Evidence for use3

  • FERACCRU® —for patients with mild-to-moderate inflammatory bowel disease (IBD) or in remission, with IDA (Hb ≥9.5 g/dl)
  • In the Phase III study FERACCRU® relieved IDA by week 12 in comparison to placebo
  • At week 12: 
    • mean Hb concentrations increased by 2.2 g/dl from baseline in the FERACCRU® group compared to placebo
    • in the FERACCRU® group, 66% had normal[A]  Hb levels (percentage based on a responder analysis)
    • the efficacy of FERACCRU® was not affected by IBD type, severity, or time since flare.

[A] normal Hb; women ≥12 g/dl; men ≥13 g/dl

Tolerability and safety

  • FERACCRU® was generally well tolerated with:
    • no deterioration of disease-specific quality of life scores or disease severity
    • no treatment-related serious adverse events attributed to FERACCRU® at 12 weeks 
    • 74% of patients completing 64 weeks of treatment
  • The most frequently reported adverse reactions were gastrointestinal symptoms (abdominal pain [8%], flatulence [4%], constipation [4%], abdominal discomfort [2%], distension [2%], and diarrhoea [3%]) and these were mainly mild to moderate in severity
  • Reported severe adverse reactions were abdominal pain [4%], constipation [0.9%], and diarrhoea [0.9%].

References

  1. FERACCRU® 30 mg hard capsules—Great Britain summary of product characteristics. www.medicines.org.uk/emc/  
  2. FERACCRU® 30 mg hard capsules—Northern Ireland summary of product characteristics. www.emcmedicines.com/en-GB/northernireland/  
  3. Gasche C, et al. Inflamm Bowel Dis 2015; 21 (3): 579–588.
  4. Stallmach A, et al. Expert Opin Pharmacother 2015; 12; 16 (18): 2859–2867.
  5. Harvey R, et al. Aliment Pharmacol Ther 1998; 12 (9): 845–848.
  6. Snook J, et al. Gut 2021; 70: 2030–2050.
  7. FERACCRU® 30 mg hard capsules—Great Britain patient information leaflet. www.medicines.org.uk/emc/product/2083/pil  
  8. FERACCRU® 30 mg hard capsules—Northern Ireland patient information leaflet. www.emcmedicines.com/en-gb/northernireland/medicine?id=05178c0c-776a-4eb6-b05e-85e9ca408165&type=pil  

UK-HAE-FER-2100127

Date of preparation: December 2021

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/. Adverse events should also be reported to Norgine Pharmaceuticals Ltd on: Tel. +44 (0)1895 826 606 Email. medinfo@norgine.com