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Inicio Enfermedades Infecciosas y Microbiología Clínica (English Edition) Amphotericin B deoxycolate availability in Spain
Journal Information
Vol. 41. Issue 8.
Pages 525-526 (October 2023)
Vol. 41. Issue 8.
Pages 525-526 (October 2023)
Letter to the Editor
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Amphotericin B deoxycolate availability in Spain
Disponibilidad de anfotericina B desoxicolato en España
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David Campany-Herreroa,
Corresponding author
david.campany@vallhebron.cat

Corresponding author.
, Òscar Len-Abadb
a Servicio de Farmacia, Hospital Universitari Vall Hebron, Barcelona, Spain
b Servicio de Enfermedades Infecciosas, Hospital Universitari Vall Hebron, Barcelona, Spain
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Dear Editor,

With regard to the scientific letter recently published in the journal Enfermedades Infecciosas y Microbiología Clínica by Capilla-Miranda et al.,1 which describes the treatment option with liposomal amphotericin B for fluconazole-resistant Meyerozyma guilliermondiicystitis, we would like to present updated information about amphotericin B deoxycholate availability in Spain.

The authors of the letter are right to point out that, in Spain, ever since the withdrawal some years ago of the only amphotericin B deoxycholate product available (Fungizona®), only two lipid forms of this antifungal are currently on the market (Abelcet® and AmBisome®),2 which have established themselves as the preferred option when systemic treatment must be considered. Despite that, other clinical scenarios requiring the topical administration of amphotericin B are not uncommon. Because of its physical and chemical properties (water soluble), ease of use (free of lipid particles) and lower cost, amphotericin B deoxycholate has classically been used to prepare different formulations intended for administration by different routes. These include intravesical administration, such as that proposed by Capilla-Miranda et al.,1,3 the nebulised treatment or prophylaxis of pulmonary aspergillosis,4,5 intraocular injection for cases of fungal eye infection6 or other situations that require the local administration of amphotericin B.7

Despite the lack of availability in Spain of an amphotericin B deoxycholate medicinal product required by pharmacy departments to correctly formulate this antifungal, we feel it is necessary to qualify the claim made by the authors of the scientific letter regarding the difficulty obtaining this particular antifungal, and would like to share some options for easily acquiring amphotericin B deoxycholate. The first is by compounding, a practice regulated in every Spanish autonomous community through legally established pharmacies for the production of this type of medicinal product,8 while the second is through the ‘Access to Medicines in Special Situations’ programme run by the Spanish Agency of Medicines and Medical Devices (Agencia Española de Medicamentos y Productos Sanitarios),9 which facilitates the importing of amphotericin B deoxycholate marketed in other European countries. This was almost certainly the route used to obtain the medicinal product in the cases published recently in this journal.3 It is currently possible to import the product Amphotericin B® 50mg (Pharma International, SA).

We feel it is important to update information pertaining to the availability of amphotericin B deoxycholate in Spain in order to facilitate the possibility of considering a series of treatments with this antifungal, through a simpler formulation in different clinical scenarios, with greater clinical experience in several indications and with a significant cost saving.

Funding

The authors declare that they received no funding to write this paper.

References
[1]
A. Capilla-Miranda, D. Plaza-López, P. García-Clemente, F. Baquero-Artiago.
Instilaciones vesicales intermitentes con anfotericina B liposomal para el tratamiento de una cistitis por Meyerozyma guilliermondii resistente a fluconazol en un adolescente inmunodeprimido.
Enferm Infecc Microb Clin., 41 (2023), pp. 253-254
[2]
Centro de información online de medicamentos de la AEMPS. Ministerio de Sanidad. Amfotericina [accessed 6 Apr 2023]. Available from: https://cima.aemps.es/cima/publico/lista.html.
[3]
Comes-Escoda A, Villaronga-Flaqué M, Velasco-Arnaiz E, Esteban E, Pertierra-Cortada À, Noguera-Julian A. Renal fungus balls in neonates and very young infants treated with local amphotericin B deoxycolate: two cases reports and review of the literatura. Enferm Infecc Microb Clin (Engl Ed). https://doi.org/10.1016/j.eimc.2023.02.003.
[4]
A.A. Otu, P. Langridge, D.W. Denning.
An evaluation of nebulised amphotericin B deoxycholate (Fungizone®) for treatment of pulmonary aspergillosis in the UK National Aspergillosis Centre.
Mycoses., 62 (2019), pp. 1049-1055
[5]
K. Brunet, J.P. Martellosio, F. Tewes, S. Marchand, B. Rammaert.
Inhaled antifungal agents for treatment and prophylaxis of bronchopulmonary invasive mold infections.
Pharmaceutics., 14 (2022), pp. 641
[6]
W. Kongwattananon, T. Rattanaphong.
Granulomatous panuveitis in disseminated sporotrichosis: case report and review of the literature.
J Ophthalmic Inflamm Infect., 13 (2023), pp. 11
[7]
R.H. Drew, J.R. Perfect.
Conventional antifungals for invasive infections delivered by unconventional methods; aerosols, irrigants, directed injections and impregnated cement.
J Fungi (Basel)., 8 (2022), pp. 212
[8]
Departament de Salut. Generalitat de Catalunya [accessed 6 Apr 2023]. Available from: https://salutweb.gencat.cat/ca/ambits_actuacio/per_perfils/empreses_i_establiments/oficines_de_farmacia/formulacio_magistral/.
[9]
Agencia Española de Medicamentos y Productos Sanitarios [accessed 6 Apr 2023]. Available from: https://www.aemps.gob.es/medicamentos-de-uso-humano/acceso-a-medicamentos-en-situaciones-especiales/.
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