Intravenous iron (Venofer®)

Title of Guideline (must include the word “Guideline” (not Guidelines for the administration of intravenous
protocol, policy, procedure etc) iron sucrose (Venofer) to children attending as
outpatients.

Contact Name and Job Title (author) Roy Connell – Clinical Nurse Specialist

Directorate & Speciality Family Health – Paediatric Nephrology

Date of submission May 2014

Date on which guideline must be reviewed (this should January 2016

be one to three years)
Explicit definition of patient group to which it applies Children and Young People treated with
(e.g. inclusion and exclusion criteria, diagnosis) intravenous iron sucrose under the care of the
Children’s Renal Unit, QMC Campus.

Abstract This guideline describes the Assessment,

administration and management of intravenous iron
sucrose in paediatric patients.

Key Words Iron, ferritin, TSats, Child, Young Person, Renal.

Statement of the evidence base of the guideline – has the 2a

guideline been peer reviewed by colleagues?

Evidence base: (1-5)

1a meta analysis of randomised controlled trials
1b at least one randomised controlled trial
2a at least one well-designed controlled study
without randomisation
2b at least one other type of well-designed quasi-
experimental study
3 well –designed non-experimental descriptive
studies (ie comparative / correlation and case
studies)
4 expert committee reports or opinions and / or
clinical experiences of respected authorities
5 recommended best practise based on the clinical
experience of the guideline developer
Consultation Process Children’s Renal Unit guideline review.
Paediatric Clinical Guidelines Group
Target audience Clinicians and healthcare professionals caring for
children and young people treated with peritoneal
dialysis at Nottingham University Hospitals NHS
Trust

This guideline has been registered with the trust. However, clinical guidelines are guidelines only.
The interpretation and application of clinical guidelines will remain the responsibility of the
individual clinician. If in doubt contact a senior colleague or expert. Caution is advised when using
guidelines after the review date.

Roy Connell Page 1 of 5 January 2013

These guidelines are to ensure the safe administration of intravenous iron
sucrose (Venofer®) to all peritoneal dialysis (PD), pre-dialysis and renal
transplant patients requiring treatment for absolute and/or functional iron
deficiency.

Indications
Management of anaemia should be considered in patients with anaemia of
chronic kidney disease when their haemoglobin level is less than or equal to
11 g/dL (or 10 g/dL if younger than 2 years of age).

Iron-deficiency in chronic kidney disease

Absolute iron deficiency should be:

 Diagnosed in people with stage 5 Chronic Kidney Disease (CKD) with

a ferritin level of less than 100 micrograms/L
 Considered in people with stage 3 and 4 CKD if the ferritin level is less
than 100 micrograms/L

In children with CKD who have serum ferritin levels greater than 100mcg/L,
functional iron deficiency should be defined by:

 Transferrin saturation of less than 20%

Patients receiving Epoetin therapy should be given iron supplements to

maintain:

 Serum ferritin levels between 200 and 500 micrograms/L

and
 Transferrin saturation levels above 20% (unless ferritin is greater than
800 micrograms/L)

Maximum Iron Levels

In children with chronic kidney disease treated with iron, serum ferritin levels
should not rise above 800 micrograms/L.
In order to prevent this, the dose of iron should be reviewed when serum
ferritin levels reach 500 micrograms/L.

Roy Connell Page 2 of 5 January 2013

Assessment
Patients with evidence or history of the following should be excluded or
reassessed by the consultant Paediatric Nephrologist
:
 Hypersensitivity to parental iron.
 Asthma, Eczema or other atopic allergy.
 Cirrhosis or Hepatitis.
 Acute or Chronic infection.
 Anaemia not attributed to iron deficiency.
 Pregnancy.
Also:
 Serum ferritin greater than 500 micrograms/L.
 Transferrin saturation greater than 30%

Blood pressure, pulse and weight of the child should be measured and
recorded prior to administration.

Site for cannulation/venepuncture should be assessed and negotiated with

the child.

Access
An appropriately sized cannula should be sited and flushed with Sodium
Chloride 0.9%. This method is required if the child is receiving the first dose of
IV iron sucrose.

Alternatively, administration of the IV iron can be carried out using a butterfly

device after performing venepuncture for blood sampling. (Connell 2011)

Iron Sucrose Dose

 3mg/kg/dose (maximum dose 200mg) made up to 20ml with Sodium

Chloride 0.9%.

 Maximum weekly dose of IV iron sucrose is 200mg or 3mg/kg (whichever

is less) three times a week.

 A test dose must be administered to patients receiving IV iron for first time.
(see below)

Equipment

 Resuscitation equipment.
 Anaphylactic shock drug box
 Oxygen either piped or bottled.

Roy Connell Page 3 of 5 January 2013

Administration

 Intravenous injection over 3 - 5 minutes (by slow bolus)

 Test dose should be 3mg/kg administered at 20ml/hr, using syringe
driver, for first 15 minutes. If no adverse reactions have been observed
during this period, the remainder of the infusion can be given over the
next 15 minutes.

MHRA Alert (August 2013): Intravenous iron and serious hypersensitivity reactions: new
strengthened recommendations to manage and minimise risk.

A European-wide review of intravenous iron products for iron deficiency and anaemia has
recommended strengthened measures are taken to manage and minimise the risk of
hypersensitivity reactions.
 IV iron should only be given in an environment where the patient can be adequately
monitored, and where resuscitation facilities are available. In case of a
hypersensitivity reaction, treatment should be stopped immediately and appropriate
management initiated.
 There are no clear data that an initial test dose minimises risk. Therefore, an initial
test dose on first use of an IV iron product for a patient is no longer recommended.

Response to recommendations for this guideline.

 All administrations of intravenous iron to children are carried out in a controlled
environment with resuscitation facilities.
 A slower infusion (test dose) for first dose in children will continue to be given to
assess suitability of giving as a bolus for subsequent treatment.

http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON300398

Observation
Blood pressure should be rechecked after 15 minutes in patients receiving a
test dose.
Side effects include:

 Anaphylactic reaction (very rare)

 Headache
 Hypotension
 Metallic taste
 Nausea and vomiting

Blood pressure and pulse should be measured and recorded after the infusion
has finished.

The patient should be observed for 30 minutes after the infusion has finished.

Roy Connell Page 4 of 5 January 2013

Discharge

Cannula should be removed and site checked.

Any bleeding from venepuncture site should be stopped and site checked.

Follow up
Serum ferritin and Transferrin saturations to be reviewed 2 - 4 weeks after IV
Iron course.
If patient remains iron deficient then to receive subsequent iron doses after
discussion with clinician.

References
Anaemia management in people with chronic kidney disease.
NICE clinical guideline 39. September 2006.

Connell, R (2011) Improved outpatients pathway for giving intravenous iron to

children. Journal of Renal Nursing. May vol 3 No 3.

Roy Connell Page 5 of 5 January 2013