Michaela Döring1, Karin Melanie Cabanillas Stanchi2, Manon Queudeville2, Judith Feucht2, Franziska Blaeschke3, Patrick Schlegel2, Tobias Feuchtinger3, Peter Lang2, Ingo Müller4, Rupert Handgretinger2, Werner J Heinz5. 1. Department I - General Paediatrics, Haematology/Oncology, Children's Hospital, University Hospital Tübingen, Hoppe-Seyler-Str.1, 72076, Tübingen, Germany. michaela.doering@med.uni-tuebingen.de. 2. Department I - General Paediatrics, Haematology/Oncology, Children's Hospital, University Hospital Tübingen, Hoppe-Seyler-Str.1, 72076, Tübingen, Germany. 3. Ludwig-Maximilians-University München, Dr. von Hauner'sches Kinderspital, Paediatric Haematology, Oncology and Stem Cell Transplantation, Lindwurmstrasse 4, 80337, Munich, Germany. 4. Department of Paediatrics Haematology and Oncology, University Hospital Hamburg-Eppendorf, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany. 5. Division of Infectious Diseases, Department of Internal Medicine II, University Medical Centre Würzburg, Oberdürrbacher Straße 6, 97080, Würzburg, Germany.
Abstract
PURPOSE: Paediatric recipients of haematopoietic stem cell transplantation (HSCT) have a high risk for invasive fungal infections. Posaconazole oral suspension has proven to be effective in antifungal prophylaxis in adult and paediatric patients. A new posaconazole tablet formulation with absorption independent of the gastric conditions was approved by the FDA in 2013. This is the first report on the use of posaconazole tablets in paediatric patients. METHODS: This single-centre study included 63 paediatric patients with haemato-oncological malignancies who received posaconazole for antifungal prophylaxis after HSCT. They were analysed for efficacy, feasibility and the safety of posaconazole. Out of 63 patients, 31 received posaconazole oral suspension and 32 received posaconazole tablets up to 200 days after transplantation. Analyses of the posaconazole trough levels were determined. RESULTS: No possible, probable or proven invasive fungal infection was observed in either group. Posaconazole trough levels were significantly higher in the tablet group than in the suspension group at all analysed time points. Drug-related adverse events were similarly low in both groups. CONCLUSIONS: Posaconazole tablets are effective in preventing invasive fungal infections in paediatric patients. As early as day 3 after starting posaconazole tablets, over 50% of the posaconazole trough levels were >500 ng/mL, while this was observed on day 14 after start with posaconazole suspension. The administration of posaconazole tablets was safe, effective and feasible as antifungal prophylaxis in paediatric patients after HSCT.
PURPOSE: Paediatric recipients of haematopoietic stem cell transplantation (HSCT) have a high risk for invasive fungal infections. Posaconazole oral suspension has proven to be effective in antifungal prophylaxis in adult and paediatric patients. A new posaconazole tablet formulation with absorption independent of the gastric conditions was approved by the FDA in 2013. This is the first report on the use of posaconazole tablets in paediatric patients. METHODS: This single-centre study included 63 paediatric patients with haemato-oncological malignancies who received posaconazole for antifungal prophylaxis after HSCT. They were analysed for efficacy, feasibility and the safety of posaconazole. Out of 63 patients, 31 received posaconazole oral suspension and 32 received posaconazole tablets up to 200 days after transplantation. Analyses of the posaconazole trough levels were determined. RESULTS: No possible, probable or proven invasive fungal infection was observed in either group. Posaconazole trough levels were significantly higher in the tablet group than in the suspension group at all analysed time points. Drug-related adverse events were similarly low in both groups. CONCLUSIONS:Posaconazole tablets are effective in preventing invasive fungal infections in paediatric patients. As early as day 3 after starting posaconazole tablets, over 50% of the posaconazole trough levels were >500 ng/mL, while this was observed on day 14 after start with posaconazole suspension. The administration of posaconazole tablets was safe, effective and feasible as antifungal prophylaxis in paediatric patients after HSCT.
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