title: Comparison of posaconazole serum concentrations from haematological cancer patients on posaconazole tablet and oral suspension for treatment and prevention of invasive fungal infections.
abstract: Posaconazole tablet formulation (PTF) was developed to optimise bioavailability. This study compared posaconazole levels between patients on the PTF and oral suspension formulation (OSF). We also examined factors that may impact posaconazole levels. The primary and secondary objectives were analysed by comparing trough levels and attainment of target level between the formulation groups. For the 86 patients on PTF and 176 on OSF, the mean first levels was 1.32 μg ml-1(SD = 0.69) and 0.81 μg ml-1(SD = 0.59), P < 0.0001 respectively. PTF group was more likely to achieve levels ≥0.7 μg ml-1than OSF group (OR 7.97 [95 CI; 3.75-16.93], P < 0.0001). Levels from patients on PTF and with presence of acid suppression, GI GVHD, mucositis or diarrhoea were not statistically different from those without these factors. For PTF, no correlation was found between patient's weight (kg) and levels (R2= 0.0536, P = 0.035). The incidences of elevation in ALT/AST or Tbili were similar between the formulation groups. In conclusion, PTF should be considered the preferred formulation because it demonstrated better absorption than the OSF. Patients on PTF for prophylaxis are more likely to attain target level and may not routinely require therapeutic drug monitoring during prophylaxis.
authors.affiliation: Department of Pharmacy Services, Oregon Health & Science University Hospital and Clinics, Portland, OR, USA.
authors.forename: Aaron N
authors.initials: AN
authors.lastname: Pham
authors.affiliation: Department of Pharmacy Services, Oregon Health & Science University Hospital and Clinics, Portland, OR, USA.
authors.forename: Joseph S
authors.initials: JS
authors.lastname: Bubalo
authors.affiliation: Department of Pharmacy Services, Oregon Health & Science University Hospital and Clinics, Portland, OR, USA.
authors.forename: James S
authors.initials: JS
authors.lastname: Lewis
mesh_terms: D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D018890:Chemoprevention / Q000379:methods*; D005260:Female; D006801:Humans; D000072742:Invasive Fungal Infections / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications*; D012189:Retrospective Studies; D044967:Serum / Q000737:chemistry*; D013535:Suspensions / Q000008:administration & dosage; D013607:Tablets / Q000008:administration & dosage; D014230:Triazoles / Q000008:administration & dosage / Q000493:pharmacokinetics*; D055815:Young Adult
chemical_list: D000935:Antifungal Agents; D013535:Suspensions; D013607:Tablets; D014230:Triazoles; C101425:posaconazole
keywords: Triazole antifungals; acute myeloid leukaemia; antifungal prophylaxis; therapeutic drug monitoring