Ferric carboxymaltose parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Parenteral formulations of iron as ferric carboxymaltose.
Drugs List
Therapeutic Indications
Uses
Anaemia - iron deficiency
Dosage
Adults
Dose and dosage schedule should be individually determined based on the calculation of the total iron deficit and must not be exceeded.
Total cumulative dose of ferric carboxymaltose equivalent to the total iron deficit should be determined by the haemoglobin (Hb) level and body weight.
Hb less than 10g/dL (less than 6.2 mmol/L):
Patients with body weight less than 35kg: 500mg
Patients with body weight 35kg to less than 70kg: 1500mg (no more than 1000mg of iron (20mL) per week)
Patients with body weight greater than or equal to 70kg: 2000mg (no more than 1000mg of iron (20mL) per week)
Hb greater than or equal to 10g/dL to less than 14g/dL (6.2 mmol/L to less than 8.7 mmol/L):
Patients with body weight less than 35kg: 500mg
Patients with body weight 35kg to less than 70kg: 1000mg
Patients with body weight greater than or equal to 70kg: 1500mg (no more than 1000mg of iron (20mL) per week)
Hb greater than or equal to 14g/dL (greater than or equal to 8.7 mmol/L):
An initial dose of 500mg iron should be given and iron parameters should be checked before repeating the dose.
Post iron repletion assessment
Following repletion, regular assessments should be completed to ensure that iron levels are corrected and maintained. The Hb level should be re-assessed no earlier than 4 weeks post ferric carboxymaltose administration to allow adequate time for erythropoiesis and iron utilisation.
Maximum tolerated single dose
A single dose of ferric carboxymaltose should not exceed 1000mg of iron (20ml) per week.
Intravenous injection
By intravenous injection using undiluted solution up to 1000mg iron (up to a maximum of 15mg/kg body weight).
For doses from 100mg and up to 200mg iron, ferric carboxymaltose has no minimum administration time.
For doses greater than 200mg and up to 500mg iron, ferric carboxymaltose should be administered at a rate of 100mg/minute.
For doses greater than 500mg and up to 1000mg iron, ferric carboxymaltose should be administered over 15 minutes.
Intravenous infusion
By intravenous infusion up to a maximum single dose of 1000mg of iron (up to a maximum of 20mg/kg body weight).
Children
Children aged 14 years and over
(See Dosage; Adult)
Patients with Renal Impairment
Undiluted ferric carboxymaltose may be administered directly into the venous limb of the dialyser during a haemodialysis session.
A single maximum daily injection dose of 200mg iron should not be exceeded in haemodialysis-dependent chronic kidney disease patients. No safety data on haemodialysis-dependent chronic kidney disease patients receiving single doses of more than 200mg iron are available.
Administration
For intravenous injection, intravenous infusion or during a haemodialysis session via the dialyser.
Contraindications
Bacteraemia
Children under 14 years
First trimester of pregnancy
Haemochromatosis
Haemosiderosis
Porphyria cutanea tarda
Precautions and Warnings
Allergic disposition
Atopy
Autoimmune disease
Infection
Inflammatory disorder
Restricted sodium intake
Asthma
Eczema
Hepatic impairment
Second trimester of pregnancy
Third trimester of pregnancy
Sodium content of formulation may be significant
Exclude non-iron deficiency anaemia
Have available adrenaline injection 1:1000 for anaphylaxis
Treat and control infections prior to commencing therapy
Do not start oral iron therapy until at least 5 days after last injection
If extravasation occurs follow local policy & seek expert help immediately
Observe patient closely during and immediately after administration
Resuscitation facilities must be immediately available
Diagnosis of iron deficiency must be based on appropriate laboratory tests
Caution with every dose of IV iron even if previously well tolerated
Monitor serum phosphate during high doses or long-term treatment
Monitor serum phosphate in patients with hypophosphataemia risk factors
Consider interrupting treatment if persistent hypophosphataemia occurs
May cause anaphylactic / anaphylactoid reactions
Monitor for hypersensitivity reactions for at least 30 mins after admin
Seek medical advice if worsening fatigue with myalgias or bone pain occurs
Discontinue if anaphylactoid reaction occurs
Discontinue if serious allergic or anaphylactic reaction occurs
Advise patients that hypersensitivity reactions may be life threatening
Avoid in patients with hepatic impairment where iron overload is a precipitating factor (e.g. Porphyria Cutanea Tarda). Careful monitoring of iron status is recommended to avoid iron overload.
Paravenous leakage at injection site may cause irritation and brown discolouration of the skin. Administration should be stopped immediately if paravenous leakage occurs.
Monitor iron status and parameters such as serum ferritin and transferrin saturation in order to avoid iron overload/accumulation.
Injectable 1:1000 adrenaline solution should be available in case of anaphylactic/anaphylactoid reactions. Additional treatment with antihistamines and/or corticosteroids should be given as appropriate.
Cases of hypophosphataemia leading to hypophosphataemic osteomalacia and fractures requiring medical attention have been reported. This has mainly happened in patients with existing risk factors and after prolonged exposure to high dose intravenous iron.
Pregnancy and Lactation
Pregnancy
Ferric carboxymaltose is contraindicated during the first trimester of pregnancy and should be used with caution in the second and third trimesters.
The manufacturer does not recommend using ferric carboxymaltose injections during pregnancy. Iron deficiency anaemia occurring in the first trimester of pregnancy can normally be adequately treated with oral iron. It is recommended that treatment with IV iron be confined to the second and third trimester if oral iron therapy is ineffective or impracticable. Later in pregnancy, any benefits of using IV iron should be carefully weighed against the risks: anaphylactic or anaphylactoid reactions could have serious consequences for both mother and foetus. Animal studies indicate that iron released from ferric carboxymaltose does cross the placenta and is associated with skeletal abnormalities in the foetus. Foetal bradycardia could occur following administration of intravenous ferric carboxymaltose. The manufacturer states that this is usually transient and a consequence of a hypersensitivity reaction in the mother. Careful monitoring of the unborn baby is advised if the pregnant women is administered intravenous ferric carboxymaltose.
Lactation
Ferric carboxymaltose is considered safe for use during breastfeeding.
The manufacturer states that ferric carboxymaltose may be used when breastfeeding. Intravenous ferric carboxymaltose increases breast milk iron in mothers with iron deficiency anaemia. Breastfed neonates of these mothers appear to have no serious adverse reactions (LactMed). The manufacturer advises that ferric carboxymaltose is excreted in human breast milk at low levels (concentrations less than or equal to 1%) and concludes that based on limited data regarding its use in breastfeeding women, it is unlikely to represent a risk to the nursing infant.
Side Effects
Abdominal pain
Alanine aminotransferase increased
Anaphylactic reaction
Anaphylactoid reaction
Angioedema
Anxiety
Arthralgia
Aspartate aminotransferase increased
Back pain
Bronchospasm
Chest pain
Chills
Constipation
Diarrhoea
Dizziness
Dysgeusia
Dyspepsia
Dyspnoea
Erythema
Facial oedema
Fatigue
Flatulence
Flushing
Gamma glutamyl transferase (GGT) increased
Headache
Hypersensitivity reactions
Hypertension
Hypophosphataemia
Hypotension
Increase in alkaline phosphatase
Increase in lactate dehydrogenase
Influenza-like symptoms
Injection site reactions
Kounis syndrome
Loss of consciousness (transient)
Malaise
Muscle spasm
Myalgia
Nausea
Painful extremities
Pallor
Paraesthesia
Peripheral oedema
Phlebitis
Presyncope
Pruritus
Pyrexia
Rash
Syncope
Tachycardia
Urticaria
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: November 2019
Reference Sources
Summary of Product Characteristics: Ferinject 50 mg iron/mL solution for injection/infusion. Vifor Pharma UK Limited. Revised October 2020.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Ferric carboxymaltose Last revised: 03 December 2018
Last accessed: 20 November 2019
MHRA Drug Safety Update November 2020
Available at: https://www.mhra.gov.uk
Last accessed: 13 January 2021
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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