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posaconazol in children's

Edoardo Bruno Vicenzi, Simone Cesaro
INTRODUCTION: Posaconazole is a broad-spectrum triazole widely used to prevent and treat invasive mycoses in adults. Since it received marketing authorization more than a decade ago, many authors have reported on its off-label use in pediatric patients, despite the fact that the pharmacokinetics, safety and efficacy in children have not been extensively investigated. AREAS COVERED: We reviewed pediatric studies published between 2010 and 2017 describing the prophylactic and therapeutic use of posaconazole, with special attention to the correlation between oral dose, plasma levels, safety, and effectiveness...
June 18, 2018: Expert Review of Anti-infective Therapy
María T Rosanova, Carla Voto, María S Mussini, Claudia Sarkis, Sandra Gómez, Norma Sberna, Susana Carnovale, Beatriz Caracciolo, Roberto Lede
There is limited information on the use of posaconazole in children. This retrospective and descriptive study was conducted to evaluate the clinical, microbiological characteristics and evolution of patients treated with posaconazole between August 2010 and March 2017. We included 16 children. Median age: 161 months (interquartile range -IQR- 69-173 m). All had underlying disease and a proven invasive fungal infection. The most frequent isolated were Mucor spp. and Aspergillus spp. The mean posaconazole dose was 600 mg/day (400-800 mg/day) and the median duration of treatment was 223 days (IQR 48-632)...
June 1, 2018: Archivos Argentinos de Pediatría
Sophida Boonsathorn, Iek Cheng, Frank Kloprogge, Carlos Alonso, Charmion Lee, Bilyana Doncheva, John Booth, Robert Chiesa, Adam Irwin, Joseph F Standing
OBJECTIVES: The objectives of this study were to investigate the population pharmacokinetics of posaconazole in immunocompromised children, evaluate the influence of patient characteristics on posaconazole exposure and perform simulations to recommend optimal starting doses. METHODS: Posaconazole plasma concentrations from paediatric patients undergoing therapeutic drug monitoring were extracted from a tertiary paediatric hospital database. These were merged with covariates collected from electronic sources and case-note reviews...
April 20, 2018: Clinical Pharmacokinetics
Romina Valenzuela, Patricio García, Marlon Barraza, Julia Palma, Paula Catalán, M Elena Santolaya, J Pablo Torres, Jorge Morales
Background There is no consensus on the optimal dosage use of posaconazole (PSC) for invasive fungal infection (IFI) in pediatric patients and normally it is adjusted with drug levels (DLs) ≥ 0.7 μg/ml and ≥ 1.25 μg/ml for prophylaxis and treatment, respectively. Objective To describe the experience of monitoring DLs of PSC in immunocompromised pediatric patients with IFI and to determine if the recommended doses reach CP effective in prophylaxis (≥ 0.7 μg/mL) and treatment (≥ 1.25 μg/mL). Method A retrospective analysis in children who received PSC from January 2012 to October 2016, in the Oncology and Bone Marrow Transplant units at Hospital Calvo Mackenna was done Six patients with 78 DLs were reviewed (4 prophylaxis and 4 treatment)...
2018: Revista Chilena de Infectología: órgano Oficial de la Sociedad Chilena de Infectología
Ricardo García-Sepúlveda, Josefina Navarrete-Solís, Hiram Villanueva-Lozano, Rogelio de J Treviño-Rangel, Gloria M González, Jorge Enríquez-Rojas, Javier Molina-Durazo, Roberto Arenas-Guzmán
Mucormycosis of the scalp is a rare cutaneous presentation of the disease. It is also an unusual infection in children. We present the case of a 4-year-old girl with acute lymphoblastic leukemia, who presented with atypical cutaneous mucormycosis simulating an ecthyma gangrenosum lesion. Risk factors for the infection are diabetes, neoplastic diseases, immunosuppression in organ transplant recipients, and neutropenia. The cutaneos forms have been associated with trauma, burns and surgical wounds. First line treatment is amphotericin B...
December 1, 2017: Journal of Dermatological Case Reports
Françoise Livio
The main pharmacovigilance updates in 2017 are reviewed. Denosumab : rebound-associated multiple vertebral fractures after discontinuation. Canagliflozine: increased risk of foot/leg amputations. Biologic and targeted cancer therapies, direct-acting antivirals for chronic hepatitis C: risk of hepatitis B reactivation. Checkpoint inhibitors : immune-related adverse events and graft rejection. Fingolimod : rebound-associated reactivation of MS following withdrawal. Daclizumab: risk of severe liver injury leading to restricted use in MS patients...
January 10, 2018: Revue Médicale Suisse
Edoardo Bruno Vicenzi, Elisabetta Calore, Nunzia Decembrino, Massimo Berger, Katia Perruccio, Francesca Carraro, Sara Rossin, Maria Caterina Putti, Mariadelfina Molinaro, Gloria Tridello, Simone Cesaro
BACKGROUND: Posaconazole is a triazole with limited pharmacokinetic information in children. This study assessed the correlation between posaconazole oral solution daily dosage/kg/body weight and trough plasma level. METHODS: A total of 97 hematology-oncology pediatric patients with ≥1 posaconazole plasma concentration level (PPC) assessment in the first 6 weeks after the start of posaconazole treatment were included. RESULTS: Posaconazole was used as prophylaxis in 84 of 97 (87%) patients and as therapy in 13 of 97 (13%)...
March 2018: European Journal of Haematology
Esra Pekpak, Talia İleri, Elif İnce, Mehmet Ertem, Zümrüt Uysal
BACKGROUND: Vincristine (VCR) is one of the main drugs of acute lymphoblastic leukemia (ALL) treatment. Azole antifungal medications are used for treatment or prophylaxis of invasive fungal infections in acute leukemia. Coadministration of these drugs increases the risk of VCR toxicity. OBSERVATIONS: We presented a girl with ALL using posaconazole prophylaxis. She developed VCR toxicity that included tubulopathy, high blood pressure, neuropathic pain, difficulty walking, diffuse muscular weakness, constipation, abdominal pain...
December 6, 2017: Journal of Pediatric Hematology/oncology
Eric Rhoden, W Allan Nix, William C Weldon, Rangaraj Selvarangan
Parechovirus A3 (Par-A3, formerly human parechovirus 3) is an emerging viral infection of the central nervous system in children. We used an automated, homogeneous, cell based assay to identify itraconazole and posaconazole as inhibitors of Par-A3, with antiviral activity below concentrations clinically attainable in pediatric patients. Currently, there is no approved antiviral treatment for Par-A3 infection, despite numerous reports of serious Par-A3 disease in neonates and infants.
January 2018: Antiviral Research
Jessica McMahon, Yves Théorêt, Julie Autmizguine, Henrique Bittencourt, Bruce Tapiéro, Philippe Ovetchkine
Plasma posaconazole exposure was assessed in 13 children who underwent a hematopoietic stem cell transplant. The median dosage was 12.5 mg/kg per day, divided into 3 doses. Of these 13 patients, 46.2% (6) and 30.8% (4) achieved concentrations higher than 0.7 and 1.25 mg/L, respectively. In children at high risk, a higher dosage might be needed to achieve target concentrations.
November 24, 2017: Journal of the Pediatric Infectious Diseases Society
T Jancel, P A Shaw, C W Hallahan, T Kim, A F Freeman, S M Holland, S R Penzak
WHAT IS KNOWN AND OBJECTIVE: Posaconazole is an extended-spectrum triazole antifungal with activity against a variety of clinically significant yeasts and moulds. Posaconazole is not currently approved by the U.S. Food and Drug Administration for use in children younger than 13 years of age. Our primary objective was to describe the dosing and observed trough concentrations with posaconazole oral suspension in paediatric patients at the National Institutes of Health Clinical Center (Bethesda, MD)...
February 2017: Journal of Clinical Pharmacy and Therapeutics
Kim Vanstraelen, Anca Colita, Ana Maria Bica, Raf Mols, Patrick Augustijns, Nele Peersman, Pieter Vermeersch, Pieter Annaert, Isabel Spriet
BACKGROUND: Antifungal prophylaxis remains challenging in immunocompromised children as no clear consensus has yet been reached about which drug to be used. Posaconazole has a broad spectrum of activity, a favorable safety profile and excellent prophylactic activity in adults. However, a lack of pharmacokinetic studies in pediatric patients hampers routine implementation. This study investigates the pharmacokinetics of a newly introduced posaconazole dosing regimen based on the body surface area in pediatric hematologic patients...
February 2016: Pediatric Infectious Disease Journal
Nina M Clark, Shellee A Grim, Joseph P Lynch
Posaconazole, a fluorinated triazole antifungal drug, is approved by the U.S. Food and Drug Administration (FDA) for (1) prophylaxis against Aspergillus and Candida infections in immunocompromised patients at high risk for these infections and (2) oropharyngeal candidiasis (OPC), including cases refractory to fluconazole and/or itraconazole. The European Medicines Agency (EMA) has approved posaconazole for (1) treatment of aspergillosis, fusariosis, chromoblastomycosis, and coccidioidomycosis in patients who are refractory to or intolerant of other azoles or amphotericin B; (2) first-line therapy for OPC for severe disease or in those unlikely to respond to topical therapy; and (3) prophylaxis of invasive fungal infections in high-risk hematologic patients and stem cell transplant recipients...
October 2015: Seminars in Respiratory and Critical Care Medicine
C D G Hines, X Song, S Kuruvilla, G Farris, C G Markgraf
INTRODUCTION: Noxafil® (posaconazole; POS) is a potent, selective triazole antifungal approved for use in adults as an oral suspension, oral tablet and intravenous (IV) Solution. In support of pediatric administration of POS IV Solution to children<two years of age, a nonclinical study in juvenile pre-weaning Beagle dogs was conducted, which showed enlarged lateral ventricles in the brain at the conclusion of a 6 week dosing period. METHODS: To evaluate the impact of this finding on older age dogs, which would support administration to children>two years of age, two studies were undertaken using magnetic resonance imaging (MRI) to monitor brain ventricle size longitudinally during three months administration of POS IV in adult and juvenile dogs...
November 2015: Journal of Pharmacological and Toxicological Methods
Amanda Gwee, Noel Cranswick, Nigel Curtis
Posaconazole is a broad-spectrum antifungal agent used for the prevention and treatment of invasive fungal infections. It is currently only licensed for use in children greater than 12 years of age. Absorption of the oral formulation is unpredictable and affected by mucositis and concomitant medications. We reviewed studies of posaconazole use in children younger than 12 years in relation to attainment of target serum concentrations.
June 2015: Pediatric Infectious Disease Journal
Özlem Tüfekçi, Şebnem Yılmaz Bengoa, Fatma Demir Yenigürbüz, Erdem Şimşek, Tuba Hilkay Karapınar, Gülersu İrken, Hale Ören
OBJECTIVE: Rapid and effective treatment of invasive fungal infection (IFI) in patients with leukemia is important for survival. In this study, we aimed to describe variations regarding clinical features, treatment modalities, time of restarting chemotherapy, and outcome in children with IFI and acute leukemia (AL). MATERIALS AND METHODS: The charts of all pediatric AL patients in our clinic between the years of 2001 and 2013 were retrospectively reviewed. All patients received prophylactic fluconazole during the chemotherapy period...
December 2015: Turkish Journal of Haematology: Official Journal of Turkish Society of Haematology
Jasem Mohamadi, Mahsa Motaghi, Jafar Panahi, Mohamad Reza Havasian, Ali Delpisheh, Mitra Azizian, Iraj Pakzad
The purpose of the present study is to evaluate the sensitivity of Candida species isolated from oral candidiasis and diaper dermatitis infections in children. The children referring to private and public clinics in Ilam, Iran were exmined for oral candidiasis and diaper dermatitis. In this study, 248 oral candidiasis and diaper dermatitis samples were collected and cultured.Candida species were identified by using standard methods. Resistance and sensitivity to amphotericin B, nystatin, ketoconazole, fluconazole, itraconazole, clotrimazole, and posaconazole were determined using the CLSI M44-A standard disk diffusion method...
2014: Bioinformation
S Deng, G S de Hoog, P E Verweij, J Zoll, M Ilkit, F Morsali, P Abliz, X Wang, P Zhan, L Yang, H Hasimu, W Liao, W Pan, S Seyedmousavi
OBJECTIVES: Trichophyton violaceum is an anthropophilic dermatophyte that is endemic to parts of Africa and Asia and is sporadic in Europe. T. violaceum mainly causes tinea capitis in both children and adolescents. Although the infections caused by T. violaceum are of considerable medical importance, its antifungal susceptibility profile remains poorly examined. METHODS: In this study, we tested the in vitro antifungal susceptibility of a set of clinical T. violaceum isolates obtained from tinea capitis patients, using the CLSI broth microdilution method...
April 2015: Journal of Antimicrobial Chemotherapy
Mar Martí-Carrizosa, Ferran Sánchez-Reus, Francesca March, Pere Coll
BACKGROUND: Candida parapsilosis is one of the main causes of fungemia in tertiary-care hospitals. Few studies have analysed the changes in its distribution over a long period. We compared the distribution of C. parapsilosis with that of other fungi over a 15-y period in a tertiary hospital. METHODS: The susceptibility of C. parapsilosis was analysed using the new species-specific clinical breakpoints. The C. parapsilosis complex species were differentiated molecularly...
June 2014: Scandinavian Journal of Infectious Diseases
Chris Stockmann, Jonathan E Constance, Jessica K Roberts, Jared Olson, Elizabeth H Doby, Krow Ampofo, Justin Stiers, Michael G Spigarelli, Catherine M T Sherwin
Invasive fungal infections are a significant cause of morbidity and mortality in children. Successful management of these systemic infections requires identification of the causative pathogen, appropriate antifungal selection, and optimisation of its pharmacokinetic and pharmacodynamic properties to maximise its antifungal activity and minimise toxicity and the emergence of resistance. This review highlights salient scientific advancements in paediatric antifungal pharmacotherapies and focuses on pharmacokinetic and pharmacodynamic studies that underpin current clinical decision making...
May 2014: Clinical Pharmacokinetics
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