Drugs List

Therapeutic Indications

Uses

Anaemia - iron deficiency

Iron sucrose injection or infusion is indicated for the treatment of iron deficiency in the following indications:

- Where a rapid iron supply is clinically necessary.
- In patients who cannot tolerate oral iron therapy or who are non-compliant.
- In active inflammatory bowel disease where oral iron preparations are ineffective.
- In chronic kidney disease when oral iron preparations are less effective.

Administration

By slow intravenous (IV) injection or infusion only; other routes contraindicated. Administration by intravenous drip infusion is the preferred route as this may help to reduce the risk of hypotensive episodes and paravenous leakage.

By slow IV injection - administer iron hydroxide sucrose complex at a rate of 1ml undiluted solution per minute (i.e. 5 minutes per vial) and not exceeding 200mg (2 vials) per injection. Apply pressure to the injection site for at least 5 minutes to reduce the risk of paravenous leakage after IV injection administration. Paravenous leakage of iron sucrose may cause pain, inflammation and brown discolouration of the skin at the injection site.

By IV infusion - administer diluted solution of iron hydroxide sucrose complex at an infusion rate of not more than 5ml in at least 15 minutes.

Contraindications

Bacteraemia
First trimester of pregnancy
Haemochromatosis
Haemosiderosis
Porphyria cutanea tarda

Precautions and Warnings

Allergic disposition
Atopy
Autoimmune disease
Children under 18 years
Inflammatory disorder
Eczema
Hepatic impairment
Second trimester of pregnancy
Severe asthma
Third trimester of pregnancy

Advise ability to drive/operate machinery may be affected by side effects
Treat and control infections prior to commencing therapy
Do not start oral iron therapy until at least 5 days after last injection
Observe patient closely during and immediately after administration
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 signs and symptoms of allergic reaction
Monitor for hypersensitivity reactions for at least 30 mins after admin
Discontinue if anaphylactoid reaction occurs
Do not take oral iron preparations during treatment
Advise patients that hypersensitivity reactions may be life threatening

Pregnancy and Lactation

Pregnancy

Iron sucrose injection is contraindicated during the first trimester of pregnancy and should be used with caution during the second and third trimester.

There is no data from the use of iron sucrose in pregnant women in the first trimester. Data from the use of iron sucrose in pregnant women in the second and third trimester indicated no adverse effects on pregnancy or on the health of the foetus/newborn child.

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. Iron sucrose injection should only be used in pregnant women in whom oral iron is ineffective or cannot be tolerated and the level of anaemia is judged sufficient to put mother and foetus at risk.

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.

Following administration of parenteral irons, foetal bradycardia may occur. This is usually due to a hypersensitivity reaction in the mother. As a result, if parenteral irons are intravenously administered to a pregnant woman, the unborn baby should be carefully monitored.

Lactation

Iron sucrose is considered safe for use during breastfeeding.

There is limited information on the excretion of iron in human milk following administration of intravenous iron sucrose. The manufacturer states that when a small group of healthy breast-feeding mothers with iron deficiency were treated with 100mg of iron in the form of iron sucrose, the iron content of the breast milk in these women had not increased when measured four days after treatment. No differences were observed when compared to the control group.

The manufacturer also states that non-metabolised iron sucrose is unlikely to pass into the mother's milk and therefore, iron sucrose should not present a risk to the nursing child.

Animal studies do not indicate direct or indirect harmful effects to the nursing child.

Side Effects

Abdominal pain
Alanine aminotransferase increased
Anaphylactic reaction
Anaphylactoid reaction
Angioedema
Anxiety
Arthralgia
Aspartate aminotransferase increased
Asthenia
Back pain
Bradycardia
Bronchospasm
Chest pain
Chromaturia
Circulatory collapse
Cold sweat
Confusion
Constipation
Diarrhoea
Dizziness
Dysgeusia
Dyspnoea
Erythema
Extremity pain
Fatigue
Flushing
Gamma glutamyl transferase (GGT) increased
Headache
Hyperhidrosis
Hypersensitivity reactions
Hypertension
Hypoaesthesia
Hypotension
Impaired consciousness
Increase in lactate dehydrogenase
Increased serum ferritin
Influenza-like symptoms
Injection site reactions
Light-headedness
Loss of consciousness (transient)
Malaise
Muscle spasm
Myalgia
Nausea
Pallor
Palpitations
Paraesthesia
Peripheral oedema
Phlebitis
Pruritus
Pyrexia
Rash
Somnolence
Syncope
Tachycardia
Thrombophlebitis
Tremor
Urticaria
Vomiting

Presentation

Solution for injection / infusion containing iron hydroxide sucrose complex.

Drugs List

Therapeutic Indications

Uses

Anaemia - iron deficiency

Iron sucrose injection or infusion is indicated for the treatment of iron deficiency in the following indications:

- Where a rapid iron supply is clinically necessary.
- In patients who cannot tolerate oral iron therapy or who are non-compliant.
- In active inflammatory bowel disease where oral iron preparations are ineffective.
- In chronic kidney disease when oral iron preparations are less effective.

Dosage

Dose and dosage schedule should be individually determined based on the calculation of the total iron deficit.

The MHRA have advised that there are no clear data that an initial test dose of intravenous iron minimises the risk of hypersensitivity reactions: conversely, it may give false reassurance because hypersensitivity reactions have been reported in patients despite a negative initial test dose. The MHRA concludes that therefore, an initial test dose on first use of an IV iron product for a patient is no longer recommended.

Adults

Children

Patients with Renal Impairment

Administration

By slow intravenous (IV) injection or infusion only; other routes contraindicated. Administration by intravenous drip infusion is the preferred route as this may help to reduce the risk of hypotensive episodes and paravenous leakage.

By slow IV injection - administer iron hydroxide sucrose complex at a rate of 1ml undiluted solution per minute (i.e. 5 minutes per vial) and not exceeding 200mg (2 vials) per injection. Apply pressure to the injection site for at least 5 minutes to reduce the risk of paravenous leakage after IV injection administration. Paravenous leakage of iron sucrose may cause pain, inflammation and brown discolouration of the skin at the injection site.

By IV infusion - administer diluted solution of iron hydroxide sucrose complex at an infusion rate of not more than 5ml in at least 15 minutes.

Contraindications

Bacteraemia
First trimester of pregnancy
Haemochromatosis
Haemosiderosis
Porphyria cutanea tarda

Precautions and Warnings

Allergic disposition
Atopy
Autoimmune disease
Children under 18 years
Inflammatory disorder
Eczema
Hepatic impairment
Second trimester of pregnancy
Severe asthma
Third trimester of pregnancy

Advise ability to drive/operate machinery may be affected by side effects
Treat and control infections prior to commencing therapy
Do not start oral iron therapy until at least 5 days after last injection
Observe patient closely during and immediately after administration
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 signs and symptoms of allergic reaction
Monitor for hypersensitivity reactions for at least 30 mins after admin
Discontinue if anaphylactoid reaction occurs
Do not take oral iron preparations during treatment
Advise patients that hypersensitivity reactions may be life threatening

Pregnancy and Lactation

Pregnancy

Iron sucrose injection is contraindicated during the first trimester of pregnancy and should be used with caution during the second and third trimester.

There is no data from the use of iron sucrose in pregnant women in the first trimester. Data from the use of iron sucrose in pregnant women in the second and third trimester indicated no adverse effects on pregnancy or on the health of the foetus/newborn child.

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. Iron sucrose injection should only be used in pregnant women in whom oral iron is ineffective or cannot be tolerated and the level of anaemia is judged sufficient to put mother and foetus at risk.

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.

Following administration of parenteral irons, foetal bradycardia may occur. This is usually due to a hypersensitivity reaction in the mother. As a result, if parenteral irons are intravenously administered to a pregnant woman, the unborn baby should be carefully monitored.

Lactation

Iron sucrose is considered safe for use during breastfeeding.

There is limited information on the excretion of iron in human milk following administration of intravenous iron sucrose. The manufacturer states that when a small group of healthy breast-feeding mothers with iron deficiency were treated with 100mg of iron in the form of iron sucrose, the iron content of the breast milk in these women had not increased when measured four days after treatment. No differences were observed when compared to the control group.

The manufacturer also states that non-metabolised iron sucrose is unlikely to pass into the mother's milk and therefore, iron sucrose should not present a risk to the nursing child.

Animal studies do not indicate direct or indirect harmful effects to the nursing child.

Side Effects

Abdominal pain
Alanine aminotransferase increased
Anaphylactic reaction
Anaphylactoid reaction
Angioedema
Anxiety
Arthralgia
Aspartate aminotransferase increased
Asthenia
Back pain
Bradycardia
Bronchospasm
Chest pain
Chromaturia
Circulatory collapse
Cold sweat
Confusion
Constipation
Diarrhoea
Dizziness
Dysgeusia
Dyspnoea
Erythema
Extremity pain
Fatigue
Flushing
Gamma glutamyl transferase (GGT) increased
Headache
Hyperhidrosis
Hypersensitivity reactions
Hypertension
Hypoaesthesia
Hypotension
Impaired consciousness
Increase in lactate dehydrogenase
Increased serum ferritin
Influenza-like symptoms
Injection site reactions
Light-headedness
Loss of consciousness (transient)
Malaise
Muscle spasm
Myalgia
Nausea
Pallor
Palpitations
Paraesthesia
Peripheral oedema
Phlebitis
Pruritus
Pyrexia
Rash
Somnolence
Syncope
Tachycardia
Thrombophlebitis
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: September 2019.

Reference Sources

Summary of Product Characteristics: Venofer (Iron Sucrose). Vifor Pharma UK Ltd. Revised October 2019.

MHRA Drug Safety Update September 2013
Available at: https://www.mhra.gov.uk
Last accessed: 17 August 2019.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 17 August 2019.