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1 DRUG AND PROFILE REPORTS Ferric carboxymaltose: a guide to its use in iron-deficiency anaemia Ferric carboxymaltose, a novel iron complex that consists of a ferric hydroxide core stabilized by a carbohydrate shell, allows for controlled delivery of iron. Administered intravenously, it is effective in the treatment of irondeficiency anaemia, delivering a replenishment dose of up to 1000 mg of iron (maximum dose 15 mg/kg bodyweight per week). Adapted from Drugs 2009; 69 (6): 739-56.[1] Adis Evaluation Key clinical benefits and limitations of ferric carboxymaltose in iron-deficiency anaemia Clinical benefits Produces rapid and sustained increases in haemoglobin levels, improves iron stores, increases the amount of iron available for erythropoiesis and improves health-related quality of life Effective in various patient populations Provides the efficacy of intravenous administration without the inconvenience of multiple small-dose injections with long infusion times Patients generally require only one or two infusions to replenish iron stores Risk of acute toxicity is low because the release of iron is slow and controlled A test dose is not required before administration Well tolerated Limitations Results of trials evaluating its efficacy, safety and cost effectiveness relative to other intravenous iron preparations in various patient populations would be beneficial in clarifying its position What is the rationale for developing the drug? Anaemia is frequently caused by iron deficiency, which is associated with a variety of co-existing conditions. Symptoms of iron-deficiency anaemia include fatigue, headache, dizziness, breathlessness, palpitations and reduced cognitive function. Iron-deficiency anaemia may reduce the patient’s health-related quality of life (HR-QOL), physical performance and ability to work, and increase morbidity and mortality.[1] Treatment of iron-deficiency anaemia involves identifying and treating the cause of the condition, as well as replacing iron.[1] Treatment with oral iron is a convenient, effective, inexpensive first-line therapy in many populations with iron-deficiency anaemia; however, such formulations may not be suitable or effective in all patients, due to poor absorption and tolerability.[1] To overcome these problems, a number of intravenous iron preparations have been used for the replacement of iron.[1] However, some of the currently available preparations (e.g. sodium ferric gluconate and iron sucrose) require multiple administrations of low doses to replenish iron stores.[1] There is a need, therefore, for the development of preparations of iron that are able to rapidly replenish iron stores, with minimal risks of adverse effects. Ferric carboxymaltose (FerinjectÒ) is a complex of iron that allows for administration of a large replenishment dose (£1000 mg of iron; maximum dose 15 mg/kg bodyweight per week) over a short infusion period. The dose of ferric carboxymaltose and other iron preparations is expressed in milligrams of elemental iron. iron within the cells of the reticuloendothelial system and subsequent delivery to the iron-binding proteins ferritin and transferrin, with minimal risk of release of large amounts of ionic iron in the serum.[3,4] After intravenous administration, ferric carboxymaltose is rapidly cleared from the circulation and is distributed primarily to the bone marrow (»80%) and also to the liver and spleen.[1,4] This results in transient elevations in serum iron levels, improvements in serum ferritin levels and transferrin saturation, and, ultimately, in the correction of haemoglobin levels and replenishment of depleted iron stores.[3,4] Who should receive the drug? Intravenous ferric carboxymaltose is approved in several European countries for the treatment of iron deficiency when oral preparations are not able to be used or are not effective (table I).[2] What is its efficacy with regard to ... Intravenously administered ferric carboxymaltose was effective in the treatment of iron-deficiency anaemia in several 6- to 12-week, randomized, open-label, controlled trials in various patient populations (n = 200–454), including those with inflammatory bowel disease,[5] heavy uterine 1172-0360/10/0001-001/$19.95 ª 2010 Adis Data Information BV. All rights reserved. How does the drug work? Ferric carboxymaltose consists of a ferric hydroxide core stabilized by a carbohydrate shell.[2,3] The design of this macromolecular complex allows for controlled delivery of

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