Drugs List

Therapeutic Indications

Uses

Iron deficiency anaemia in patients with chronic kidney disease

Administration

This medication can be administered either as an intravenous bolus injection or during a haemodialysis session directly into the venous limb of the dialyser.

It may be administered undiluted or diluted in up to 20ml sterile 0.9% sodium chloride.

Contraindications

Bacteraemia
Children under 18 years
Decompensated liver disease
First trimester of pregnancy
Haemochromatosis
Haemosiderosis
Hepatitis

Precautions and Warnings

Allergic disposition
Atopy
Autoimmune disease
Infection
Inflammatory disorder
Eczema
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
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
Rapid intravenous administration may cause acute short-lasting hypotension
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 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

Paravenous leakage when administering ferric derisomaltose, may cause irritation of the skin and potentially long lasting brown discolouration at the injection site.

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.

There is no adequate data from the use of ferric derisomaltose during pregnancy. Studies in animals have shown teratogenicity and reproductive toxicity.

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.

Lactation

Ferric derisomaltose is considered safe for use during breastfeeding.

The manufacturer notes that there is no information available on the excretion of ferric derisomaltose in human breast milk.

Side Effects

Abdominal pain
Anaphylactic reaction
Anaphylactoid reaction
Angioedema
Arrhythmias
Arthralgia
Blurred vision
Chest pain
Constipation
Cramp
Deafness (transient)
Diarrhoea
Dizziness
Dysphonia
Dyspnoea
Exacerbation of rheumatoid arthritis
Fatigue
Feeling hot
Fever
Flushing
Foetal bradycardia
Haemolysis
Headache
Hypersensitivity reactions
Hypertension
Hypotension
Inflammation (injection site)
Influenza-like syndrome
Itching
Kounis syndrome
Loss of consciousness (transient)
Mental status changes
Myalgia
Nausea
Numbness
Pain / soreness (injection site)
Palpitations
Paraesthesia
Phlebitis (injection site)
Pruritus
Rash
Restlessness
Seizures
Shivering
Sweating
Tachycardia
Tremor
Urticaria
Vomiting

Presentation

Solution for injection containing iron as ferric derisomaltose.

Drugs List

Therapeutic Indications

Uses

Iron deficiency anaemia in patients with chronic kidney disease

Dosage

The iron dose and dosage schedule must be individualised based on the clinical response to treatment including evaluation of haemoglobin, ferritin and transferrin saturation, concomitant treatment with an erythropoiesis stimulating agent (ESA) and the doses of ESA treatment. Targets may vary from patient to patient and depending on local guidelines.

Maintenance therapy with IV iron treatment may be given as small doses administered at regular intervals to maintain iron status tests stable within specific limits with the intent of avoiding development of iron deficiency or decline of iron test parameters below specific levels.

Adults

Administration

This medication can be administered either as an intravenous bolus injection or during a haemodialysis session directly into the venous limb of the dialyser.

It may be administered undiluted or diluted in up to 20ml sterile 0.9% sodium chloride.

Contraindications

Bacteraemia
Children under 18 years
Decompensated liver disease
First trimester of pregnancy
Haemochromatosis
Haemosiderosis
Hepatitis

Precautions and Warnings

Allergic disposition
Atopy
Autoimmune disease
Infection
Inflammatory disorder
Eczema
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
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
Rapid intravenous administration may cause acute short-lasting hypotension
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 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

Paravenous leakage when administering ferric derisomaltose, may cause irritation of the skin and potentially long lasting brown discolouration at the injection site.

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.

There is no adequate data from the use of ferric derisomaltose during pregnancy. Studies in animals have shown teratogenicity and reproductive toxicity.

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.

Lactation

Ferric derisomaltose is considered safe for use during breastfeeding.

The manufacturer notes that there is no information available on the excretion of ferric derisomaltose in human breast milk.

Side Effects

Abdominal pain
Anaphylactic reaction
Anaphylactoid reaction
Angioedema
Arrhythmias
Arthralgia
Blurred vision
Chest pain
Constipation
Cramp
Deafness (transient)
Diarrhoea
Dizziness
Dysphonia
Dyspnoea
Exacerbation of rheumatoid arthritis
Fatigue
Feeling hot
Fever
Flushing
Foetal bradycardia
Haemolysis
Headache
Hypersensitivity reactions
Hypertension
Hypotension
Inflammation (injection site)
Influenza-like syndrome
Itching
Kounis syndrome
Loss of consciousness (transient)
Mental status changes
Myalgia
Nausea
Numbness
Pain / soreness (injection site)
Palpitations
Paraesthesia
Phlebitis (injection site)
Pruritus
Rash
Restlessness
Seizures
Shivering
Sweating
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: Diafer 50mg/ml solution for injection. Pharmacosmos UK Limited. Revised August 2020.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 11 February 2020