Ferric derisomaltose parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Solution for injection/infusion containing iron as ferric derisomaltose.
Drugs List
Therapeutic Indications
Uses
Rapid replenishment of depleted iron stores
Treatment of iron deficiency anaemia
Dosage
Adults
Iron replacement in patients with iron deficiency anaemia
The dose and dosage schedule for this medication must be individually established for each patient based on a calculation of the total iron deficit. The optimal haemoglobin target level may vary in different patient groups. Please refer to official guidelines. The dose of this medication is expressed in mg of elemental iron.
The total iron dose is calculated by the following Ganzoni formula, where haemoglobin is abbreviated Hb:
Total iron dose [mg iron] = [ Body weight (kg) x (Target Hb - Actual Hb) (g/dl) x 2.4 ]+ Iron for iron stores (mg iron).
A. It is recommended to use the patient's ideal body weight or pre-pregnancy weight.
B. To convert Hb [mM] to Hb [g/dl] you should multiply Hb [mM] by factor 1.61145.
C. Factor 2.4 = 0.0034 x 0.07 x 10,000
0.0034: Iron content of haemoglobin is 0.34%.
0.07: Blood volume 70ml/kg of body weight equivalent to 7% of body weight.
10,000: The conversion factor 1g/dl = 10,000mg/l
D. For a person with a body weight above 35kg, the iron stores are approximately 500mg or above. Iron stores of 500mg are at the lower limit normal for small women. Some guidelines suggest using 10mg to 15mg iron/kg body weight.
E. Default Hb target is 15g/dl in the Ganzoni formula. In special cases such as pregnancy consider using a lower haemoglobin target.
Iron deficiency anaemia will not appear until essentially all iron stores have been depleted. Iron therapy should, therefore, replenish both haemoglobin iron and iron stores.
After the total iron deficit has been corrected, patients may require continued therapy with this medication to maintain target levels of haemoglobin and acceptable limits of other iron parameters.
Iron replacement for blood loss
Iron therapy in patients with blood loss should supply an amount of iron equivalent to the amount of iron represented in the blood loss.
If the Hb level is reduced
Use the previous Ganzoni formula considering that the depot iron does not need to be restored:
Total iron dose [mg iron] =[ Body weight (kg) x (Target Hb - Actual Hb) [g/dl] x 2.4
If the volume of blood lost is known
The administration of 200mg ferric derisomaltose results in an increase of haemoglobin which is equivalent to 1 unit blood:
Iron to be replaced [mg iron] = number of units blood lost x 200.
Administration
This medication can be administered either as an intravenous bolus injection, as an intravenous drip infusion or as a direct injection into the venous limb of the dialyser.
The number of single IV iron administrations should be kept to a minimum due to the associated risk of hypersensitivity reactions.
Intravenous bolus injection
Ferric derisomaltose may be administered as an intravenous bolus injection up to 500mg up to three times a week at an administration rate of up to 250mg iron/minute. It may be administered undiluted or diluted in 20ml sterile 0.9% sodium chloride.
Intravenous drip infusion
The cumulative iron dose required may be administered in a single infusion up to 20mg iron/kg body weight or as weekly infusions until the cumulative iron dose has been administered.
If the cumulative iron dose exceeds 20mg iron/kg body weight, the dose must be split in two administrations with an interval of at least one week. Whenever possible, it is recommended that 20mg iron/kg body weight is given in the first administration. Dependent on clinical judgement the second aministration could await follow-up laboratory tests.
Doses up to 1000mg must be infused over more than 15 minutes.
Doses exceeding 1000mg must be infused over 30 minutes or more.
Ferric derisomaltose should be added to maximum 500ml sterile 0.9% sodium chloride.
Injection into dialyser
Ferric derisomaltose may be administered during a haemodialysis session directly into the venous limb of the dialyser under the same procedures as outlined for intravenous bolus injection.
Contraindications
Bacteraemia
Children under 18 years
Decompensated liver disease
First trimester of pregnancy
Haemochromatosis
Haemosiderosis
Porphyria cutanea tarda
Precautions and Warnings
Allergic disposition
Atopy
Autoimmune disease
Infection
Inflammatory disorder
Eczema
Hepatic impairment
Second trimester of pregnancy
Severe asthma
Third trimester of pregnancy
Exclude non-iron deficiency anaemia
Have available adrenaline injection 1:1000 for anaphylaxis
Treat and control infections prior to commencing therapy
If extravasation occurs follow local policy & seek expert help immediately
Observe patient closely during and immediately after administration
Rapid intravenous administration may cause acute short-lasting hypotension
Resuscitation facilities must be immediately available
Always administer by slow intravenous injection or infusion
Diagnosis of iron deficiency must be based on appropriate laboratory tests
Caution with every dose of IV iron even if previously well tolerated
Monitor for hypersensitivity reactions for at least 30 mins after admin
Large doses may impart brown colour to serum from blood sample after admin.
May give falsely decreased values of serum calcium
May give falsely elevated values of serum bilirubin
Discontinue if anaphylactoid reaction occurs
Do not take oral iron preparations during treatment
Advise patients that hypersensitivity reactions may be life threatening
In compensated liver dysfunction, parenteral iron should only be administered after careful benefit/risk assessment. Avoid parental iron administration in patients with hepatic impairment (alanine aminotransferase and or aspartate aminotransferase greater than 3 times the upper limit of normal) where iron overload is a precipitating factor, in particular porphyria cutanea tarda.
Pregnancy and Lactation
Pregnancy
Ferric derisomaltose is contraindicated during the first trimester of pregnancy and should be used with caution during the second and third trimesters.
The manufacturer advises that iron deficiency anaemia occurring during 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.
Following administration of parental irons, foetal bradycardia may occur. This is usually due to a hypersensitivity reaction in the mother. As a result, if parental irons are intravenously administered to a pregnant woman, the unborn baby should be carefully monitored.
There is no adequate data from the use of ferric derisomaltose during pregnancy. Studies in animals have shown teratogenicity and reproductive toxicity.
Lactation
Ferric derisomaltose is considered safe for use during breastfeeding.
The manufacturer advises that the transfer of iron from ferric derisomaltose to human milk was very low. At therapeutic doses of ferric derisomaltose no effects on the breastfed newborn or infant are anticipated.
Side Effects
Abdominal pain
Anaphylactic reaction
Anaphylactoid reaction
Angioedema
Arrhythmias
Arthralgia
Back pain
Blurred vision
Bronchospasm
Bruising at injection site
Burning pain at injection site
Chest pain
Chills
Constipation
Dermatitis
Diarrhoea
Discolouration (injection site)
Dizziness
Dysgeusia
Dyspepsia
Dysphonia
Dyspnoea
Elevation of liver enzymes
Erythema at injection site
Extravasation
Fatigue
Fever
Flushing
Foetal bradycardia
Headache
Hypersensitivity reactions
Hypertension
Hypophosphataemia
Hypotension
Infections
Influenza-like symptoms
Injection site reactions
Irritation (injection site)
Kounis syndrome
Loss of consciousness (transient)
Malaise
Mental status changes
Muscle spasm
Myalgia
Nausea
Pain / soreness (injection site)
Paraesthesia
Phlebitis (injection site)
Pruritus
Rash
Seizures
Shivering
Skin discolouration
Sweating
Swelling (injection site)
Tachycardia
Tremor
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: February 2020
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Summary of Product Characteristics: Monofer 100mg/ml solution for injection/infusion. Pharmacosmos UK Limited. Revised May 2020.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 11 February 2020
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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