Venofer (Baxter Healthcare)
5 mL vials containing 20 mg/mL
Approved indication: iron deficiency anaemia associated with haemodialysis
Australian Medicines Handbook section 7.6
Patients who are having regular haemodialysis can develop anaemia. The patients' demand for iron will increase when they are given erythropoietin. If oral supplements of iron are unable to meet this increased demand, parenteral iron should be considered.
Iron sucrose solution is given by intravenous infusion. The molecule then dissociates with the elemental iron being taken up by iron stores and the sucrose being eliminated in the urine. When administered with erythropoietin, iron sucrose will increase the haemoglobin in reticulocytes.
A clinical trial of iron sucrose solution involved 77 patients who had dialysis-associated anaemia and had been taking erythropoietin for at least four months. The patients were given a slow injection three times a week. Seventy completed a course of 10 doses (1000 mg iron). Within five weeks of completing the course, 60 patients had a haemoglobin greater than 11 g/dL, from a baseline mean of 10.3 g/dL, on at least one occasion. There were also increases in serum ferritin and transferrin saturation. Although erythropoietin doses were reduced the change was not significant.1
Some patients can have an allergic reaction to iron products. In the pivotal trial there were no cases of anaphylaxis.1 The common adverse events reported in trials of iron sucrose include hypotension, cramps, nausea, vomiting and headache.
A trial in the USA has tested iron sucrose in 23 patients who were hypersensitive to iron dextran. Most of the patients completed the course of injections and none of them withdrew because of adverse effects.2
While iron sucrose may have an advantage over iron dextran its safety and efficacy needs to be compared with other parenteral iron formulations such as iron polymaltose.
- Charytan C, Levin N, Al-Saloum M, Hafeez T, Gagnon S, Van Wyck DB. Efficacy and safety of iron sucrose for iron deficiency in patients with dialysis-associated anemia: North American Clinical Trial. Am J Kidney Dis 2001;37:300-7.
- Van Wyck DB, Cavallo G, Spinowitz BS, Adhikarla R, Gagnon S, Charytan C, et al. Safety and efficacy of iron sucrose in patients sensitive to iron dextran: North American Clinical Trial. Am J Kidney Dis 2000;36:88-97.
Some of the views expressed in the following notes on newly approved products should be regarded as preliminary, as there may have been limited published data at the time of publication, and little experience in Australia of their safety or efficacy. However, the Editorial Executive Committee believes that comments made in good faith at an early stage may still be of value. Before new drugs are prescribed, the Committee believes it is important that more detailed information is obtained from the manufacturer's approved product information, a drug information centre or some other appropriate source.