This webpage is intended for UK Healthcare Professionals only

Webpage contains promotional material

Prescribing Information can be found at the end of this webpage

CLICK HERE

If you are interested in
iron deficiency in inflammatory bowel disease

CLICK HERE

If you are interested in
iron deficiency in patients listed for surgery

Welcome to this Iron Deficiency Anaemia resource from Pharmacosmos, designed for healthcare professionals who manage patients with inflammatory bowel disease or listed for surgery

Monofer logo

For patients ≥18 years for treatment of iron deficiency when oral iron preparations are ineffective or cannot be used or where there is a clinical need to deliver iron rapidly. The diagnosis must be based on laboratory tests.

Iron deficiency in inflammatory bowel disease

The impact of anaemia on the quality of life of patients with inflammatory bowel disease (IBD) is significant. IBD-related iron deficiency anaemia (IDA) increases the risk of hospitalisation, and adds to healthcare costs.1

Achieve treatment goals by treating your patient's full iron need

According to European Crohn's and Colitis Organisation (ECCO) guidelines, the goal of iron supplementation is to normalise haemoglobin (Hb) levels and iron stores.1

The aim of therapy for IDA, as stated in the ECCO guidelines, is to increase Hb levels by more than 20 g/l or to normal values within 4 weeks1

The guidelines also state that IBD patients with IDA often have a total iron need of 1000 - 2000 mg.1

Click here to read a summary of the ECCO guideline, including diagnostic and treatment algorithms

CLICK HERE

In an observational study of 282 patients, including 149 with IBD, the mean iron need of IBD patients was >1400 mg,2 (calculated using the simplified dosing method – see below).

This study also highlighted that the need for retreatment with IV iron may be reduced by using doses above 1000 mg.2

How do you calculate the IV iron dose needed for your IBD patients?

Calculate iron dose using a simplified dosing scheme.3

Hb (g/l) Body weight 50 kg to <70 kg Body weight ≥70 kg
≥100 1000 mg 1500 mg
<100 1500 mg 2000 mg

Monofer® SPC.
The amount of iron that can be administered to a patient as a single dose depends on the Intravenous (IV) iron product used. Refer to individual product SPCs for full prescribing details. Individualised dosing is recommended in certain patient groups.

View the Monofer simplified and individualised dosing schemes here

CLICK HERE

Increased iron doses may support improved rates of iron repletion4

Primary endpoint was change in Hb from baseline to week 8 based on non-inferiority between oral and IV iron. Non-inferiority was not demonstrated.

93% of patients treated with Monofer >1000 mg achieved increases in Hb of ≥20 g/l by week 85

The need for retreatment may be reduced by using doses above 1000 mg2

Adapted from Frigstad SO, et al. Gastroenterol Res Pract. 2017;2017:4585164. doi: 10.1155/2017/4585164. Epub 2017 Oct 22

At 52 weeks, 83% of patients receiving >1000 mg Monofer did not require retreatment2
  • Monofer offers convenient and fast iron correction in just one visit, up to 20 mg/kg.3,6–8
  • Monofer is the only fast IV iron that can be administered in a single dose exceeding 1000 mg.6
  • All patients with a body weight ≥75 kg and Hb ≥100 g/l can be treated with a single dose.3

Each IV iron administration is associated with a risk of a hypersensitivity reaction. To minimise risk, the number of single IV administrations should be kept to a minimum.3

Potential benefits of Monofer

Potential benefits of high-dose administration of IV iron such as Monofer compared with low-dose regimens include:

  • Potential for fewer infusions9
  • Fewer clinic visits10
  • Less patient travel and reduced absence from work10

Fewer infusions may improve capacity and resource utilisation10

Budget modelling indicates that using Monofer in place of ferric carboxymaltose (FCM) or iron sucrose in patients with IBD and IDA results in a reduction in the number of infusions required to correct iron deficit.9*

*Figures stated here are from budget impact modelling. Iron deficits were modelled using a simplified dosing approach and the base case analysis was conducted in a sub-group of patients with IBD and IDA with a mean bodyweight of 75.4 kg (SD 17.4 kg) and haemoglobin levels of 108 g/l (SD 14 g/l).9 The mean iron deficit was calculated at 1,374 mg.11 Individualised dosing is recommended in certain patient groups, refer to product SPC.3

Treating 2.5 IBD patients with Monofer rather than FCM could avoid one infusion.9

CLICK HERE to request a representative visit to learn more about the resource impact of treating iron deficiency in IBD patients with Monofer in the UK

CLICK HERE

Monofer tolerability

Monofer is well tolerated, confirmed in >10 million doses in the post marketing experience and in >3,000 patients in clinical studies.12,13

  • Low incidence of adverse drug reactions (ADRs)4,8,14–19
  • No dose dependency of ADRs4,15,19
  • Low occurrence of clinically significant hypophosphataemia4,15,16,20

Hypophosphataemia

Hypophosphataemia can be a side effect of treatment with iron.3

Published data do not appear to show a marked association between Monofer and severe hypophosphataemia.20

Weighing scales icon

Up to 20 mg/kg in
just one visit

IV drip icon

Infusion

≤ 1000 mg over > 15 minutes

> 1000 mg over ≥ 30 minutes

Syringe icon

Injection

500 mg over
2 minutes

If iron need >20 mg/kg, administer maximum dose at first visit, second administration based on clinical judgement, at least one week after first visit.3

IV iron should only be administered when trained staff are present and the patient should be observed for at least 30 minutes following each injection.3

Monofer offers convenience for healthcare professionals and their patients

CONVENIENT6

Monofer delivers easy and fast iron correction in just ONE visit, with single dose up to 20 mg/kg3,6,8

GOOD SAFETY PROFILE6

No dose dependency of ADRs4,15,19 and no marked association with severe hypophosphataemia4,15,16,20

COST EFFECTIVE6

May reduce patient visits and waiting lists, and free up treatment capacity10

ECCO consensus on the diagnosis and management of iron deficiency and anaemia in IBD

ECCO: European Consensus on the diagnosis and management of iron deficiency and anaemia in inflammatory bowel disease

Simplified dosing guide cover

Simplified dosing guide for IV iron administration

Individual dosing guide cover

Individualised dosing guide for IV iron administration

Selecting an IV iron preparation to meet your hospital’s needs:
Real life experience from a UK hospital with Monofer (iron isomaltoside 1000)

Dr Matthew Johnson, consultant gastroenterologist at Luton & Dunstable Hospital looks at the benefits of Monofer in their hospital's experience of treating patients with IDA in terms of efficacy and tolerability, advantages for patients, increased efficiency and capacity for the Trust, and cost savings and service improvement for the CCG. (Video duration: 7:25)

References

  1. Dignass AU et al. J Crohns Colitis 2015;9:211-222
  2. Frigstad SO, et al. Gastroenterol Res Pract. 2017;2017:4585164. doi: 10.1155/2017/4585164. Epub 2017 Oct 22
  3. Monofer SmPC. Available at: https://www.medicines.org.uk/emc/product/5676/smpc [Accessed September 2018]
  4. Reinisch W, et al. Am J Gastroenterol 2013;108:1877-88
  5. Reinisch W, et al. Am J Gastroenterol 2013;108:1877-88 (supplementary data)
  6. Kalra PA, et al. Port J Nephro Hyperten 2012;26(1):13-24
  7. Jahn MR, et al. Eur J Pharmaceutics Biopharmaceutics 2011;78:480-91
  8. Hildebrandt PR, et al. Transf Altern Transf Med 2010;11(4):127-63
  9. Pollock RF, et al. Expert Opin Drug Deliv. 2017 Dec;14(12):1439-1446.
  10. Gozzard D et al. Drug Des Devel Ther 2011;5:51-60
  11. Data on file_04 Nov 2017
  12. Data on file_02 Aug 2018
  13. Data on file_01 Oct 2017
  14. Wikström B, et al. J Nephrol 2011;24(5):589-96
  15. Bhandari S, et al. Nephrol Dial Transplant 2015;30(9):1577-89
  16. Birgegård G, et al. Pharmacotherapy 2016;38(4):402-14
  17. Reinisch W, et al. Scand J Gastroenterol. 2015;50(10):1226-33
  18. Johansson PI, et al. Vox Sang 2015;109(3):257-66
  19. Kalra P, et al. Nephrol Dial Transplant. 2016 Apr;31(4):646-55
  20. Bager P, et al. Br J Clin Pharmacol 2017;83(5):1118-25
Monofer logo

For patients ≥18 years for treatment of iron deficiency when oral iron preparations are ineffective or cannot be used or where there is a clinical need to deliver iron rapidly. The diagnosis must be based on laboratory tests.

Iron deficiency in patients listed for surgery

Pre-operative anaemia is associated with increased post-operative morbidity, mortality and transfusion needs.1

An NHS BT audit found 58% of elective surgery patients were anaemic and in those patients, only 25% had recieved a pre-operative intervention.2

Treating iron deficiency can reduce the need for blood transfusion and avoid the serious risks of:1,3

  • Infection
  • Fluid overload
  • Incorrect administration of blood transfusions
  • Allosensitisation and autoimmune challenge to future transplants

Treating pre-operative anaemia may reduce the length of hospital stays and cost to the NHS1

Who is at risk of peri-operative anaemia?

  • Patients undergoing surgery expected to result in blood loss of 500 ml or with a transfusion risk of ≥10% can experience a rapid drop in post-operative haemoglobin (Hb)4,5
  • Patients with a pre-operative Hb level of <130 g/l are at increased risk of poor outcomes4
  • For every 10 g/l that patients’ Hb falls below 130 g/l there is a:6

43%

increase in transfusion need*

16%

increase in mortality*

4%

increase in length of hospital stay§

*Adjusted odds ratio (OR)

§Geometric mean ratio (GMR)

In surgical patients, a dose of 1000 mg-1500 mg of iron is sufficient to replenish iron stores and can be given in one dose of iron therapy depending on the preparation used and the patient's body weight4

To restore every 1 g of iron deficiency using autologous blood transfusion (ABT) requires 4 units of packed red blood cells (RBC).7

WATCH THE VIDEO:
Identifying, diagnosing and treating anaemia before and after surgery

CLICK HERE

NICE Quality Standard 138 (QS 138)1 is endorsed and supported by NHS England, NHS Blood and Transplant, the Royal College of Physicians and the UK Transfusion Laboratory Collaborative and describes high quality care in priority areas for improvement.

NICE1 recommends that:

  • People with iron deficiency anaemia who are having surgery are offered iron supplementation before and after surgery1
  • Hb levels are checked ≥2 weeks prior to surgery1
  • IV iron should be considered if oral iron is not appropriate1

This means that all stakeholders have a role to play in delivering the standard:

Healthcare professionals icon

Healthcare professionals (doctors, nurses and blood transfusion specialists) should offer iron supplementation before and after surgery to people with iron-deficiency anaemia.

Service providers icon

Service providers (primary and secondary care services) should ensure that systems are in place to offer iron supplementation before and after surgery to people with iron-deficiency anaemia.

Commissioners icon

Commissioners (clinical commissioning groups) should commission services that offer iron supplementation before and after surgery for people with iron-deficiency anaemia.

The independent international consensus on the peri-operative management of anaemia and iron deficiency,4 published in Anaesthesia 2017, offers peer-reviewed practical recommendations on how to introduce guidelines into clinical practice.*

  • The presence of anaemia should be investigated in all surgical procedures with expected moderate to high blood loss (>500 ml) or a transfusion risk of ≥10%4
  • Hb of <130 g/l should prompt a laboratory investigation for IDA4
  • Pre-operative treatment should target a Hb concentration of ≥130 g/l4
  • IV iron is recommended if surgery is planned for <6 weeks from IDA diagnosis4
  • IV iron should be used as a front line therapy if oral iron cannot be tolerated or is ineffective4
Flowchart depicting course of deciding to administer IV iron to a patient or continue with oral iron

* Pharmacosmos provided logistical support and funding to allow the expert panel to meet. Pharmacosmos had no influence over the content of the publication

View the Consensus Summary here

CLICK HERE

In most surgical patients, a dose of 1000-1500 mg of iron is sufficient.4 Administration of Monofer just 1 day before, or even on the day of surgery, can improve post-operative Hb recovery.4,8

Click here for the Business Case support resource provided by Pharmacosmos, to help you introduce an IV iron clinic for iron deficiency anaemia in patients undergoing surgery

CLICK HERE

Not all patients may respond to or be able to tolerate oral iron, for example:4

  • Those with functional iron deficiency4
  • Presence of chronic illness or infection4
  • Gastro-intestinal side effects4
  • Ongoing blood loss4

Monofer is the only fast IV iron that can be administered in a single dose exceeding 1000 mg up to 20 mg/kg.9,10

Weighing scales icon

Up to 20 mg/kg in
just one visit

IV drip icon

Infusion

≤ 1000 mg over > 15 minutes

> 1000 mg over ≥ 30 minutes

Syringe icon

Injection

500 mg over
2 minutes

If iron need >20 mg/kg, administer maximum dose at first visit, second administration based on clinical judgement, at least one week after first visit.10

IV iron should only be administered when trained staff are present and the patient should be observed for at least 30 minutes following each injection.10

Ability to administer up to 20 mg/kg in one visit could help with:

  • Minimising the need for blood transfusions1
  • Reducing length of stay in hospital4
  • Improving resource utilisation and costs1

Recent data from Blaudszun and colleagues11 in Anaesthesia showed that patients listed for cardiac surgery weighed on average 81.8 kg prior to surgery.

Calculate iron dose using a simplified dosing scheme.10

Hb (g/l) Body weight 50 kg to <70 kg Body weight ≥70 kg
≥100 1000 mg 1500 mg
<100 1500 mg 2000 mg

Monofer® SPC.
The amount of iron that can be administered to a patient as a single dose depends on the Intravenous (IV) iron product used. Refer to individual product SPCs for full prescribing details. Individualised dosing is recommended in certain patient groups.

View the Monofer simplified dosing scheme

CLICK HERE

View the Monofer individualised dosing scheme

CLICK HERE

Monofer offers fast iron correction in one visit, up to 20 mg/kg. Each IV iron administration is associated with a risk of a hypersensitivity reaction. Thus to minimise the risk, the number of single IV iron administrations should be kept to a minimum.10

Monofer tolerability

Monofer is well tolerated, confirmed in >10 million doses in the post marketing experience and in >3,000 patients in clinical studies.12,13

  • Low incidence of adverse drug reactions (ADRs)9,14–20
  • No dose dependency of ADRs14,17,21
  • Low occurrence of clinically significant hypophosphataemia18,22

Hypophosphataemia

Hypophosphataemia can be a side effect of treatment with iron.10 In affected patients, hypophosphataemia typically occurs 2 weeks after IV iron administration,23 the time at which approximately 50% of patients with identified anaemia have their surgery.2

Published data do not appear to show a marked association between Monofer and severe hypophosphataemia.22

Line graph plotting phosphate levels against time in patients after a treatment of Monofer vs a treatment of FCM

No patients experienced severe hypophosphataemia while receiving Monofer22

In this small retrospective study of IBD patients, 32 individuals served as their own controls and were exposed to both ferric carboxymaltose and Monofer.22 Data on the impact of multiple doses of IV iron on phosphate levels and any associated clinical outcomes in affected individuals are lacking.

Pharmacosmos has developed services to support the implementation of pre-operative anaemia clinics and NICE QS138

CLICK HERE

Symposium report 2018 - Pre-operative anaemia: Managing patients in the pre-operative clinic Meeting. A report from a Pharmacosmos sponsored symposium that took place at the Association of Anaesthetists of Great Britain and Ireland (AAGBI) Winter Scientific Meeting, 10–12 January 2018, London

Identifying, diagnosing and treating anaemia before and after surgery

Dr Andrew Klein, consultant anaesthetist at Papworth Hospital, Cambridge discusses his current clinical practice

Experience with intravenous iron at a UK hospital

Dr Seema Agarwal, consultant anaesthetist at Liverpool Cardiac Thoracic Centre talks about her experience of introducing a pre-operative anaemia clinic, within the 18 week care pathway for cardiac surgery patients.

Targeting pre-operative IV iron treatment to the right patients in a busy clinic

Dr Rhona Sinclair, consultant anaesthetist, Newcastle-upon-Tyne Hospitals. Building on the successful implementation of a pre-assessment anaemia clinic for gastrointestinal cancer surgery patients, Dr Sinclair explains how her service overcame the limitations of being unable to administer >1g IV iron in a single dose

Diagnosis and treatment of anaemia is a NICE standard -
how are you doing in your Hospital? - part one

Dr Andrew Klein, challenges you to compare the service in your unit with the NICE Quality Standard 138

Diagnosis and treatment of anaemia is a NICE standard -
how are you doing in your Hospital? - part two

Dr Andrew Klein, discusses perioperative management of anaemia and iron deficiency, along with The International Consensus Statement and their experience at Papworth Hospital

References

  1. NICE Blood transfusion Quality Standard. December 2016. Available at: http://www.nice.org.uk/guidance/qs138 [Accessed September 2018]
  2. NHS BT National Comparative Audit of Blood Transfusion 2015. Available at: http://hospital.blood.co.uk/audits/national-comparative-audit/national-comparative-audit-reports/ [Accessed September 2018]
  3. Leffell MS, et al. Transplantation 2014;97(5):525-533
  4. Muñoz M, et al. Anaesthesia 2017;72(2):233-247
  5. Nagra NS, et al. AOTT 2016;50(5):507–13
  6. Klein AA, et al. Anaesthesia 2016;71(6):627-635
  7. Remacha A, et al. Blood Transfus 2013;11:128–39
  8. Suh DW, et al. Blood Transfus 2017;15:506-11
  9. Kalra PA, et al. Port J Nephro Hyperten 2012;26(1):13-24
  10. Monofer SmPC. Available at: https://www.medicines.org.uk/emc/product/5676/smpc [Accessed September 2018]
  11. Blaudszun G, et al. Anaesthesia 2018;73(5):572-578
  12. Data on file_02 Aug 2018
  13. Data on file_01 Oct 2017
  14. Reinisch W, et al. Am J Gastroenterol 2013;108:1877-88
  15. Hildebrandt PR, et al. Transf Altern Transf Med 2010;11(4):127-63
  16. Wikström B, et al. J Nephrol 2011;24(5):589-96
  17. Bhandari S, et al. Nephrol Dial Transplant 2015;30(9):1577-89
  18. Birgegård G, et al. Pharmacotherapy 2016;38(4):402-14
  19. Reinisch W, et al. Scand J Gastroenterol. 2015;50(10):1226-33
  20. Johansson PI, et al. Vox Sang 2015;109(3):257-66
  21. Kalra P, et al. Nephrol Dial Transplant. 2016 Apr;31(4):646-55
  22. Bager P, et al. Br J Clin Pharmacol 2017;83(5):1118-25
  23. Wolf M, et al. J Bone Miner Res 2013;28(8):1793-1803

Monofer® (iron isomaltoside 1000) prescribing information

▼This medicinal product is subject to additional monitoring, and healthcare professionals are asked to report any suspected adverse reaction

Note: Before prescribing please read full Summary of Product Characteristics. Pharmaceutical form: Iron isomaltoside 1000 is a dark brown, non-transparent solution for injection/infusion. Presentations: Iron in the form of iron isomaltoside 1000; 100 mg/ml available in vials of 100 mg/ml, 500 mg/5 ml and 1,000 mg/10 ml. Indications: Monofer® is indicated in patients ≥18 years for treatment of iron deficiency when oral iron preparations are ineffective or cannot be used or when there is a need to deliver iron rapidly. The diagnosis must be based on laboratory tests. Administration: Each IV iron administration is associated with a risk of a hypersensitivity reaction. Thus, to minimise risk, the number of single IV iron administrations should be kept to a minimum. The cumulative iron need can be determined using either the Simplified Table or the Ganzoni formula, please consult full Summary of Product Characteristics. Monofer® may be administered as an IV bolus injection of up to 500 mg at an administration rate of up to 250 mg iron/minute up to three times a week, during a haemodialysis session directly into the venous limb of the dialyser under the same procedures as outlined for IV bolus injection, or as an up to 20 mg iron per kg body weight infusion. If the cumulative iron dose exceeds 20 mg iron per kg body weight, the dose must be split into two administrations with an interval of at least one week. It is recommended whenever possible to give 20 mg iron/kg body weight in the first administration. Dependent on clinical judgement the second administration could await follow-up laboratory tests. Doses up to 1,000 mg must be administered over >15 minutes; dose above 1,000 mg must be administered over ≥30 minutes. In case of infusion, Monofer® should be added to maximum 500 ml sterile 0.9% sodium chloride. Contraindications: Non-iron deficiency anaemia, iron overload or disturbances in utilisation of iron, hypersensitivity to any of the ingredients, decompensated liver disease, or known serious hypersensitivity to other parental iron products. Warnings/Precautions: Parenterally administered iron preparations can cause potentially fatal anaphylactic/anaphylactoid reactions. The risk is enhanced for patients with known allergies, a history of severe asthma, eczema or other atopic allergy, and in patients with immune or inflammatory conditions. Monofer® should only be administered in the presence of staff trained to manage anaphylactic reactions where full resuscitation facilities are available (including 1:1000 adrenaline solution). Each patient should be observed for at least 30 minutes following administration. If hypersensitivity reactions or signs of intolerance occur during administration, the treatment must be stopped immediately. In patients with compensated liver dysfunction, parenteral iron should only be administered after careful benefit/risk assessment. Careful monitoring of iron status is recommended to avoid iron overload. Parenteral iron should be used with caution in case of acute or chronic infection. Monofer® should not be used in patients with ongoing bacteraemia. Hypotensive episodes may occur if intravenous injection is administered too rapidly. Caution should be exercised to avoid paravenous leakage when administering Monofer®. Pregnancy: Monofer® should not be used during pregnancy unless clearly necessary. The treatment should be confined to second and third trimester. In rare cases, foetal bradycardia has been observed in pregnant women with hypersensitivity reactions. Undesirable effects: No very common (≥10 %) undesirable effects listed. Common undesirable effects (1 % to 10 %): nausea; injection site reactions. For information on other undesirable effects, please consult full Summary of Product Characteristics. Legal Category: POM. Package Quantities and basic Prices: 5 vials of 1 ml, £84.75; 5 vials of 5 ml, £423.75; 2 vials of 10 ml, £339.00. Marketing Authorisation Number/Holder: PL 18380/001, Pharmacosmos A/S, Roervangsvej 30, DK-4300 Holbaek, Denmark. Date of preparation: June 2017. Further information is available on request to Pharmacosmos UK. Date of revision: January 2018

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Pharmacosmos UK Ltd. E: pvuk@pharmacosmos.co.uk, T: +44 1844 269 007