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Micafungin

A Review of its Use in the Prophylaxis and Treatment of Invasive Candida Infections

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Abstract

Intravenous micafungin (Mycamine®; Fungard®), an echinocandin, is approved in the EU for the treatment of adult (aged ≥16 years) and paediatric patients with invasive candidiasis and for the treatment of adult patients with oesophageal candidiasis. It is also approved in the EU as prophylactic treatment to prevent Candida infections in adult and paediatric patients undergoing haematopoietic stem cell transplant (HSCT) or patients who are expected to have neutropenia for ≥10 days. This article reviews the therapeutic use of micafungin for the treatment and prophylaxis of Candida infections in adult and paediatric patients, focusing on approved indications in Europe, and briefly discusses the pharmacology of the drug.

Micafungin shows very good in vitro activity against clinically relevant isolates of Candida spp., with a low propensity to be associated with the emergence of resistant isolates. The drug has a convenient once-daily dosage regimen and is associated with relatively few drug-drug interactions. In large, multinational trials in adult and/or paediatric patients with invasive candidiasis, micafungin was noninferior to intravenous caspofungin or liposomal amphotericin B. In similarly designed trials in adult patients with oesophageal candidiasis, treatment with micafungin was noninferior to that with intravenous fluconazole or caspofungin. As prophylactic treatment in adult and paediatric patients who had undergone HSCT, micafungin was superior to fluconazole therapy and noninferior to oral itraconazole in large, multicentre trials. Micafungin was generally well tolerated by participants in these clinical trials, given the severe morbidity of the underlying conditions of patients, with a similar tolerability profile to caspofungin and, in general, to fluconazole. It was better tolerated than liposomal amphotericin B or oral itraconazole. Thus, micafungin is a valuable first-line or alternative option to other antifungal agents for the management of candidaemia and invasive candidiasis in adult and paediatric patients, including neonates, and as prophylaxis against fungal infections in patients undergoing HSCT.

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    Lesley J. Scott

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Various sections of the manuscript reviewed by:M. Bassetti, Clinica Malattie Infective, Azienda Osperdaliera Universitania San Martino, Genova, Italy; B. T. Fisher, Division of Infectious Diseases, Children’s Hospital of Philadelphia, Philadelphia, PA, USA; A. H. Groll, Infectious Diseases Research Program, Center for Bone Marrow Transplantation and Department of Pediatric Hematology/Oncology, University Children’s Hospital Münster, Albert-Schweitzer Campus-1, Münster, Germany; M. Kalin, Department of Medicine Infektionskliniken, Karolinska Institute, Stockholm, Sweden; B. M. Lomaestro, Albany Medical Center Hospital Pharmacy, Albany, NY, USA; T. Rogers, St James’s Hospital, Trinity College Dublin, Department of Clinical Microbiology, Dublin, Ireland.

Data Selection

Sources: Medical literature (including published and unpublished data) on ‘micafungin’ was identified by searching databases (including MEDLINE and EMBASE) for articles published since 1996, bibliographies from published literature, clinical trial registries/databases and websites (including those of regional regulatory agencies and the manufacturer). Additional information (including contributory unpublished data) was also requested from the company developing the drug.

Search strategy: MEDLINE and EMBASE search terms were ‘micafungin’ and (‘candidiasis’ or ‘candidaemia’ or ‘candidemia’). Searches were last updated 8 October 2012.

Selection: Studies in patients with invasive or oesophageal candidiasis or candidaemia who received micafungin treatment, or in haematopoietic stem cell transplant recipients who received micafungin as prophylaxis. Inclusion of studies was based mainly on the methods section of the trials. When available, large, well controlled trials with appropriate statistical methodology were preferred. Relevant pharmacodynamic and pharmacokinetic data are also included.

Index terms: Micafungin, echinocandin, antifungal, candidaemia, invasive candidiasis, oesophageal candidiasis, prophylaxis, pharmacodynamics, pharmacokinetics, therapeutic use.

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Scott, L.J. Micafungin. Drugs 72, 2141–2165 (2012). https://doi.org/10.2165/11209970-000000000-00000

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