Intravenous iron administration

Objectives

The purpose of this guideline is to ensure all nursing and medical staff working within NHS Lothian paediatric services will be competent to prescribe, prepare, administer and monitor Monofer® intravenous (IV) iron infusions for children and young people in hospital.

Scope

This guideline applies to all nursing and medical staff caring for children and young people treated with Monofer® intravenous iron within NHS Lothian paediatric services.

Audience

NHS Lothian paediatric services.

Roles and responsibilities

It is the responsibility of all staff involved in the care of a patient receiving a Monofer® intravenous iron infusion to have read and understood this guideline. If any member of staff has any concerns they should address these with an experienced member of staff before proceeding.

Introduction, iron deficiency, indications for use and investigations prior to use

Introduction
Iron deficiency is a common problem in children with many different gastrointestinal conditions, especially inflammatory bowel disease (IBD). Iron deficiency in IBD can be caused, amongst other things, by active small bowel disease leading to poor systemic absorption or blood loss. Similarly, children with short gut syndrome that are dependent on parenteral nutrition can also become iron deficient. Control of the underlying disease or oral iron replacement is usually adequate for most IBD patients. Children with short gut syndrome may be able to absorb some enteral nutrition and thus consequently absorb enteral iron as well.
However, oral iron treatment in some patients may not be suitable due to poor oral iron tolerance, abnormal absorption due to surgery or gastrointestinal disease, significant bleeding or non-compliance. These patients will benefit from intravenous iron.
Monofer® (ferric derisomaltose) is an intravenous product indicated for the treatment of iron deficiency when oral iron preparations are ineffective or contra-indicated. Use of Monofer® in patients under the age of 18 years is unlicensed; there is however strong evidence that it is both safe and effective in paediatric patients.^3,4 Patients in whom the benefit from IV iron is uncertain should be discussed with the paediatric haematology team prior to infusion.

Iron Deficiency

Hb <100g/L and iron deficiency anaemia (MCV < 79fl; MCHC < 320g/L; ZPP > 60 micromol/mol)

Indications for Use

Persistent iron deficiency despite oral therapy
Contra-indications to oral iron or issues with compliance
Genuine intolerance to oral iron preparations
Co-morbidities affecting absorption
Patients receiving erythropoietin stimulating agents
Genetic disorders of iron transport

Investigations Prior to Treatment

FBC, ferritin, LFTs & CRP
In some patients consider iron, transferrin and transferrin saturation to help guide clinical decision making.

Cautions & contraindications

Contraindications

History of hypersensitivity to ferric derisomaltose or any of its excipients
Known serious hypersensitivity to parenteral iron products.
Anaemias not attributable to iron deficiency, unless first discussed and approved with haematology
Iron overload or disturbances in utilisation of iron
Cirrhosis, hepatitis or transaminases over three times the upper limit of normal

Cautions

Allergic disorders, eczema, hepatic dysfunction, immune conditions, pregnancy, current infection and inflammatory conditions.

Dose calculations, example calculations

Dose Calculation
The dose of Monofer® (ferric derisomaltose) is 20mg of iron per kg (maximum 1500mg). Doses should be rounded to the nearest 100mg. The Ganzoni equation can be used to calculate iron deficit, in practice the equation exceeds the maximum 20mg/kg weekly dose. Repeat Monofer® infusions should be given at least 7 days apart.

Patients Currently Taking Oral Iron Supplements
Oral iron supplements should be stopped for 7 days before and after the administration of intravenous iron.

Monitoring prior to use, preparation, administration

Monitoring Prior to Infusion
Ensure the following is complete before commencing the infusion:

Ensure there is no underlying infection.
If a patient has central intravenous access this should be used for administration, otherwise site a large gauge intravenous cannula in an appropriate large vein ensuring that the cannula flushes well. If in doubt the cannula should be resited. Monofer®, due to its high osmolarity, has the potential to cause permanent tissue damage if extravasated.
Take bloods to check Hb, MCV, ferritin, CRP and LFT.
In some patients consider iron, transferrin and transferrin saturation to help guide clinical decision making.
Baseline temperature, pulse, respiratory rate and blood pressure. Record immediately prior to commencing the infusion.

Preparation
To prepare the infusion:

Calculate the required volume of Monofer® for the prescribed dose.
Draw up the required volume of Monofer® from the vial of solution for injection and slowly add to a 100mL bag of sodium chloride 0.9%. There is no requirement to withdraw the addition volume from the infusion bag before mixing. Mix well.
For doses less than 200mg seek dilution advice from Pharmacy.
The infusion is now ready to be administered, over 60 minutes. It may be appropriate to infuse over a longer period of time for younger patients.
Doses can be given undiluted however dilution is preferable due to the high osmolarity of the undiluted solution. Contact pharmacy for further advice on dilution if required.

Administration

In 2014 the MHRA issued a drug safety update on serious hypersensitivity reactions to intravenous iron.⁵ Prior to starting the infusion ensure emergency drugs are available in the ward area in case of any adverse reaction.

All medications should be given in accordance with NHS Lothian Safe Use of Medicines Policy.
Visually inspect the infusion for particulate matter or foreign particles. Note the resulting solution will be a deep red colour.
Using a standard intravenous giving set, infuse over 60 minutes. It may be appropriate to infuse over a longer period of time for younger patients.
Flush with 30mL of sodium chloride 0.9% at the same rate as the iron infusion.

Monitoring

During the infusion

Monitor pulse, temperature, respiratory rate and blood pressure every 15 minutes during the infusion.
Monitor administration site for extravasation injury
Acute infusion reactions may develop anytime during or after the infusion.
If a patient develops a reaction follow the infusion-related reaction treatment guidance in Appendix A.

Post infusion

Monitor pulse, temperature, respiratory rate and blood pressure every 15 minutes for 30 minutes post infusion
If a patient develops a reaction follow the infusion-related reaction treatment guidance in Appendix A.
Advise patients and carers to report any signs of infection or possible side effects. Delayed hypersensitivity-like reactions may appear 1-14 days after the infusion.
Advise patients and carers to seek immediate medical advice if hypersensitivity symptoms occur.

Side effects

Possible side effects

See BNF or Summary of Product Characteristics for full list of side effects.

Common

Dizziness
Headache
Nausea

Uncommon

Blurred vision
Fatigue
Hypophosphataemia
Muscle complaints

Rare

Anaphylactic reaction
Arrhythmia
Malaise
Seizure
Tremor

Frequency not known

Kounis Syndrome (acute coronary syndrome)

Appendix A - Infusion reactions

Reaction	Symptoms	Action
Mild	Pruritus Mild rash Headache No respiratory distress or CVS instability	STOP infusion Administer oral chlorphenamine If symptoms persist treat as moderate reaction
Moderate	Urticaria/rash Tachycardia Nausea & Vomiting Back pain	STOP infusion Call emergency 2222 Lay patient flat and secure airway. Check vital signs Administer IV chlorphenamine If worsening treat as severe reaction Seek medical advice before restarting infusion
Severe	Hypotension Respiratory - Distress/Stridor/Wheeze Swollen lips/airways Reduced conscious level Reduced oxygen saturation Flushed/pale	STOP infusion Call emergency 2222 Lay patient flat and secure airway Give facial oxygen and monitor oxygen saturation Administer IM adrenaline 1:1000 If respiratory distress administer nebulised salbutamol Monitor oxygen saturation, pulse, blood pressure Repeat adrenaline if no clinical improvement Patient must stay overnight and be assessed by consultant prior to discharge

Appendix B - Anaphylaxis drug doses

Reaction	Route	Drug	Age	Dose
MILD
	Oral	Chlorphenamine	Under 2 years	1mg, max twice daily
	Oral	Chlorphenamine	2 - 5 years	1mg every 4 - 6 hours, max 6mg daily
	Oral	Chlorphenamine	6 - 11years	2mg every 4 - 6 hours, max 12mg daily
	Oral	Chlorphenamine	Over 12 years	4mg every 4 - 6 hours, max 24mg daily
MODERATE
	IV	Chlorphenamine	6 months - 5 years	2.5mg by intravenous injection
	IV	Chlorphenamine	6 - 11years	5mg by intravenous injection
	IV	Chlorphenamine	Over 12 years	10mg by intravenous injection
These doses can be repeated if necessary with max 4 doses in 24 hours
SEVERE
	IM	Adrenaline (1:1000)	Under 6 years	150 micrograms (0.15mL) by IM injection*
	IM	Adrenaline (1:1000)	6 -11 years	300 micrograms (0.3mL) by IM injection*
	IM	Adrenaline (1:1000)	Over 12 years	500 micrograms (0.5mL) by IM injection*
*Repeat dose of adrenaline after 5 minutes if no improvement in patient’s condition

Last reviewed: 11/09/2024

Next review date: 27/09/2027

Author(s): Consultant Paediatric Gastroenterologist, Specialist Paediatric Nutrition Nurse, Specialist Paediatric IBD and Liver Nurse, Senior Pharmacist.

Version: Version 1

Approved By: Guidelines Group Committee

Related resources

Definitions

CRP – C Reactive Protein
FBC – Full Blood Count
Hb – Haemoglobin
IBD – Inflammatory Bowel Disease
IV – Intravenous
LFTs – Liver Function Tests
MCHC – Mean Corpuscular Haemoglobin Concentration
MCV – Mean Cell Volume
Monofer® – Ferric Derisomaltose
ZPP – Zinc Protoporphyrin

References

Joint Formulary Committee. British National Formulary (Online) London: BMJ Group and Pharmaceutical Press. Available at [http://www.medicinescomplete.com]. Accessed 10/12/19.
Medusa IV Monographs (2019). Monofer. Available at [https://medusa.wales.nhs.uk/]. Accessed 10/12/19.
Evelina London. 2020. Evelina Paediatric Formulary. Iron Intravenous Supplementation. Available at [http://cms.ubqo.com/public/d2595446-ce3c-47ff-9dcc-63167d9f4b80/content/8c68ae04-9427-4b1e-b2cc-d96e1ed4d192]. Accessed 02/10/20.
Toh, C et al. 2016. Long term safety and efficacy of single dose parenteral iron in children with inflammatory bowel disease (IBD) in one of the largest tertiary centres in Northern England. University of Sheffield.
Medicines and Healthcare products Regulatory Agency, 2014. Intravenous iron and serious hypersensitivity reactions: strengthened recommendations. Available at [https://www.gov.uk/drug-safety-update/intravenous-iron-and-serious-hypersensitivity-reactions-strengthened-recommendations]. Accessed 02/10/20.