Iron sucrose Other names: Saccharated iron oxide Iron oxide saccharated Iron sucrose complex Sucroferric oxyhydroxide Ferric hydroxide sucrose complex Saccharated ferric oxide

In patients with liver dysfunction, parenteral iron should only be administered after careful risk/benefit assessment. Parenteral iron administration should be avoided in patients with hepatic dysfunction where iron overload is a precipitating factor, in particular Porphyria Cutanea Tarda (PCT). Careful monitoring of iron status is recommended to avoid iron overload.

As with all parenteral iron preparations, iron sucrose should not be administered concomitantly with oral iron preparations since the absorption of oral iron is reduced. Therefore, oral iron therapy should be started at least 5 days after the last injection of Venofer.

Parenteral iron should be used with caution in the case of acute or chronic infection. It is recommended that the administration of iron sucrose is stopped in patients with bacteraemia. In patients with chronic infection, a risk/benefit evaluation should be performed.

There is no data from the use of iron sucrose in pregnant women in the first trimester. Data (303 pregnancy outcomes) from the use of iron sucrose in pregnant women in the second and third trimester showed no safety concerns for the mother or newborn.

A careful risk/benefit evaluation is required before use during pregnancy and iron sucrose should not be used during pregnancy unless clearly necessary.

Iron deficiency anaemia occurring in the first trimester of pregnancy can in many cases be treated with oral iron. Treatment with iron sucrose should be confined to second and third trimester if the benefit is judged to outweigh the potential risk for both the mother and the foetus.

Foetal bradycardia may occur following administration of parenteral irons. It is usually transient and a consequence of a hypersensitivity reaction in the mother. The unborn baby should be carefully monitored during intravenous administration of parenteral irons to pregnant women.

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

There is limited information on the excretion of iron in human milk following administration of intravenous iron sucrose. In one clinical study, 10 healthy breast-feeding mothers with iron deficiency received 100 mg iron in the form of iron sucrose. Four days after treatment, the iron content of the breast milk had not increased and there was no difference from the control group (n=5). It cannot be excluded that newborns/infants may be exposed to iron derived from iron sucrose via the mother’s milk, therefore the risk/benefit should be assessed.

Preclinical data do not indicate direct or indirect harmful effects to the nursing child. In lactating rats treated with ⁵⁹Fe-labelled iron sucrose, low secretion of iron into the milk and transfer of iron into the offspring was observed. Non metabolised iron sucrose is unlikely to pass into the mother’s milk.

Fertility

No effects of iron sucrose treatment were observed on fertility and mating performance in rats.

In the case of symptoms of dizziness, confusion or light headedness following the administration of iron sucrose, patients should not drive or use machinery until the symptoms have ceased.

The most commonly reported adverse drug reaction in clinical trials with iron sucrose was dysgeusia, which occurred with a rate of 4.5 events per 100 subjects. The most important serious adverse drug reactions associated with iron sucrose are hypersensitivity reactions, which occurred with a rate of 0.25 events per 100 subjects in clinical trials. Anaphylactoid/anaphylactic reactions were reported only in the post-marketing setting (estimated as rare); fatalities have been reported.

The adverse drug reactions reported after the administration of iron sucrose in 4,064 subjects in clinical trials as well as those reported from the post-marketing setting are presented in the table below.

Common (≥1/100, <1/10)
Uncommon (≥1/1,000, <1/100)
Rare (≥1/10,000, <1/1,000)
Frequency not known¹

Immune system disorders

Uncommon: Hypersensitivity

Frequency not known¹: Anaphylactoid/anaphylactic reactions, angioedema

Nervous system disorders

Common: Dysgeusia

Uncommon: Headache, dizziness, paraesthesia, hypoaesthesia

Rare: Syncope, somnolence

Frequency not known¹: Depressed level of consciousness, confusional state, loss of consciousness, anxiety, tremor

Cardiac disorders

Rare: Palpitations

Frequency not known¹: Bradycardia, tachycardia, Kounis syndrome

Vascular disorders

Common: Hypotension, hypertension

Uncommon: Flushing, phlebitis

Frequency not known¹: Circulatory collapse, thrombophlebitis

Respiratory, thoracic and mediastinal disorders

Uncommon: Dyspnoea

Frequency not known¹: Bronchospasm

Renal and urinary disorders

Rare: Chromaturia

Gastrointestinal disorders

Common: Nausea

Uncommon: Vomiting, abdominal pain, diarrhoea, constipation

Skin and subcutaneous tissue disorders

Uncommon: Pruritus, rash

Frequency not known¹: Urticaria, erythema

Musculoskeletal and connective tissue disorders

Uncommon: Muscle spasm, myalgia, arthralgia, pain in extremity, back pain

General disorders and administration site conditions

Common: Injection/infusion site reaction²

Uncommon: Chills, asthenia, fatigue, oedema peripheral, pain

Rare: Chest pain, hyperdrosis, pyrexia

Frequency not known¹: Cold sweat, malaise, pallor, influenza like illness³

Investigations

Uncommon: Alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased, serum ferritin increased

Rare: Blood lactate dehydrogenase increased

¹ Spontaneous reports from the post-marketing setting; estimated as rare
² The most frequently reported are: injection/infusion site pain, -extravasation, -irritation, -reaction, -discolouration, -haematoma, -pruritus.
³ Onset may vary from a few hours to several days.