BNF for Children (BNFC) 2018-2019

MINERALS AND TRACE ELEMENTS›IRON,

INJECTABLE

Iron (injectable) f

IMPORTANT SAFETY INFORMATION

MHRA/CHM ADVICE: SERIOUS HYPERSENSITIVITY REACTIONS

WITH INTRAVENOUS IRON (AUGUST 2013)

Serious hypersensitivity reactions, including life-

threatening and fatal anaphylactic reactions, have been

reported in patients receiving intravenous iron. These

reactions can occur even when a previous administration

has been tolerated (including a negative test dose). Test

doses are no longer recommended and caution is needed

with every dose of intravenous iron.

Intravenous iron products should only be

administered when appropriately trained staff and

resuscitation facilities are immediately available;

patients should be closely monitored for signs of

hypersensitivity during and for at least 30 minutes after

every administration. In the event of a hypersensitivity

reaction, treatment should be stopped immediately and

appropriate management initiated.

The risk of hypersensitivity is increased in patients

with known allergies, immune or inflammatory

conditions, or those with a history of severe asthma,

eczema, or other atopic allergy; in these patients,

intravenous iron should only be used if the benefits

outweigh the risks.

Intravenous iron should be avoided in thefirst

trimester of pregnancy and used in the second or third

trimesters only if the benefit outweighs the potential

risks for both mother and fetus.

lSIDE-EFFECTS

▶Common or very commonDizziness.flushing.headache.

hypertension.hypophosphataemia.hypotension.nausea

.taste altered

▶UncommonArrhythmias.arthralgia.bronchospasm.chest

pain.chills.constipation.diarrhoea.dyspnoea.fatigue.

fever.gastrointestinal discomfort.hyperhidrosis.

hypersensitivity.loss of consciousness.muscle

complaints.pain.peripheral oedema.sensation abnormal

.skin reactions.vascular disorders.vision blurred.

vomiting

▶Rare or very rareAngioedema.anxiety.circulatory

collapse.influenza like illness.malaise.palpitations.

psychiatric disorder.seizure.syncope.tremor

SIDE-EFFECTS, FURTHER INFORMATIONAnaphylactic

reactions can occur with parenteral administration of iron

complexes and facilities for cardiopulmonary resuscitation

must be available. If children complain of acute symptoms

particularly nausea, back pain, breathlessness, or develop

hypotension, the infusion should be stopped.

OverdoseFor details on the management of poisoning,

see Iron salts, under Emergency treatment of poisoning

p. 832.

eiiiiFabove

Ferric carboxymaltose

lINDICATIONS AND DOSE

Iron-deficiency anaemia

▶BY SLOW INTRAVENOUS INJECTION, OR BY INTRAVENOUS

INFUSION

▶Child:Dose calculated according to body-weight and

iron deficit (consult product literature)

lUNLICENSED USENot licensed for use in children under

14 years.

lCAUTIONSAllergic disorders.asthma.eczema.

hypersensitivity can occur with parenteral iron and

facilities for cardiopulmonary resuscitation must be

available.infection (discontinue if ongoing bacteraemia).

oral iron should not be given until 5 days after last

injection

lINTERACTIONS→Appendix 1 : iron (injectable)

lSIDE-EFFECTS

▶Rare or very rareFace oedema.flatulence.presyncope

lPREGNANCYAvoid infirst trimester; crosses the placenta

inanimalstudies. May influence skeletal development.

lHEPATIC IMPAIRMENTUse with caution. Avoid in

conditions where iron overload increases risk of

impairment.

lPRESCRIBING AND DISPENSING INFORMATIONA ferric

carboxymaltose complex containing 5 %( 50 mg/mL) of

iron.

lMEDICINAL FORMS

There can be variation in the licensing of different medicines

containing the same drug.

Solution for injection

ELECTROLYTES:May contain Sodium

▶Ferinject(Vifor Pharma UK Ltd)A

Iron (as Ferric carboxymaltose) 50 mg per 1 mlFerinject

1000 mg/ 20 ml solution for injection vials| 1 vialP£ 154. 23

Ferinject 100 mg/ 2 ml solution for injection vials| 5 vialP£ 81. 18

Ferinject 500 mg/ 10 ml solution for injection vials| 5 vialP

£ 405. 88

eiiiiFabove

Iron dextran

lINDICATIONS AND DOSE

Iron-deficiency anaemia

▶BY DEEP INTRAMUSCULAR INJECTION

▶Child 14–17 years:Intramuscular injection to be

administered into the gluteal muscle, doses calculated

according to body-weight and iron deficit (consult

product literature)

▶BY SLOW INTRAVENOUS INJECTION, OR BY INTRAVENOUS

INFUSION

▶Child:Doses calculated according to body-weight and

iron deficit (consult product literature)

lUNLICENSED USENot licensed for use in children under

14 years.

lCONTRA-INDICATIONSActive rheumatoid arthritis.asthma

.eczema.history of allergic disorders.infection

lCAUTIONSHypersensitivity can occur with parenteral iron

and facilities for cardiopulmonary resuscitation must be

available.oral iron should not be given until 5 days after

last injection

lINTERACTIONS→Appendix 1 : iron (injectable)

lSIDE-EFFECTS

▶UncommonFeeling hot.muscle cramps

▶Rare or very rareDeafness (transient).haemolysis.

restlessness

▶Frequency not knownRheumatoid arthritis aggravated

lPREGNANCYAvoid infirst trimester.

lHEPATIC IMPAIRMENTAvoid in severe impairment.

lRENAL IMPAIRMENTAvoid in acute renal failure.

lPRESCRIBING AND DISPENSING INFORMATIONA complex

of ferric hydroxide with dextran containing 5 %( 50 mg/mL)

of iron.

570 Anaemias BNFC 2018 – 2019

Blood and nutrition

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