Introduction. This booklet also highlights ways to minimise the potential risks associated with micafungin use.

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2 2 Introduction This booklet for prescribers and nurses provides practical guidance on the safe use and administration of micafungin, an echinocandin antifungal drug. This booklet also highlights ways to minimise the potential risks associated with micafungin use.

3 3 About micafungin Micafungin is an echinocandin antifungal drug. It is active against many fungal species, including most clinically relevant species of Candida and Aspergillus spp. In vitro data show that micafungin is also active against fluconazole-resistant Candida strains. Micafungin is used to treat candidaemia and invasive candidiasis in adults and children. It is also used for the treatment of oesophaeal candidiasis, if i.v. therapy is considered appropriate for the patient. The drug is also suitable for prophylactic treatment in immunosuppressed patients. The decision to use micafungin should take into account the potential risk for the development of liver tumours. Micafungin should therefore only be used if other antifungals are not appropriate. Treatment with micafungin should only be initiated by a physician experienced in the management of systemic fungal infections. Consideration should be given to official/national guidance on the appropriate use of antifungal agents. Side effects The most frequently reported adverse reactions in clinical studies were nausea (2.8%), increased blood alkaline phosphatase (2.7%), phlebitis (2.5%, primarily in HIV infected patients with peripheral lines), vomiting (2.5%) and increased aspartate aminotransferase (2.3%). No clinically significant differences were seen when the safety data were analysed by gender or race. Micafungin is associated with the potential risk of liver tumour formation. For details of the main risks (anaphalactic/anaphalactoid reactions, exfoliative cutaneous reactions, hepatotoxicity, haemolysis and renal toxicity) and specific monitoring recommendations during micafungin treatment, refer to sections 4.4 and 4.8 of the micafungin Summary of Product Characteristics (SmPC) and the Patient monitoring section of this booklet (page 6). Initiating treatment Micafungin should be used if other antifungals are not appropriate in accordance with the SmPC, the key features of which are summarized in the Prescriber Checklist. The Prescriber Checklist should be used before administering micafungin to a new patient. The completed checklist should be kept in the patient s notes.

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7 7 Useful Contacts For further information about micafungin, please refer to the Summary of Product Characteristics or contact the local representative of the Marketing Authorisation holder: Astellas Pharma Co. Ltd. 5 Waterside Citywest Business Campus Naas Road Dublin 24 Ireland Phone: Fax: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL-Dublin 2; Tel: ; Fax: Website: medsafety@hpra.ie. Adverse events should also be reported to Astellas Pharma Co Ltd; irishdrugsafety@astellas.com; Tel: ; Fax: This publication is copyright under the Berne Convention and the Universal Copyright Convention. All rights reserved. No part of this publication may be reproduced or transmitted in any form by any means including electronic, photocopying, microfilimg and recording without the written permission of the copyright holder, application for which should be addressed to the publisher. Such written permission must always be obtained before any part of this publication is stored in a retrieval system of any nature. Date of preparation 07/2011. MYC15001IEa