Posaconazole Therapeutic Drug Monitoring in the Real-life Setting: A Single-Center Experience and Review of the Literature

2013 ◽  
Vol 33 (10) ◽  
pp. 1117-1125 ◽  
Author(s):  
Barbara N. Gross ◽  
Gabriele Ihorst ◽  
Manfred Jung ◽  
Ralph Wäsch ◽  
Monika Engelhardt
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Real Life ◽  
Therapeutic Drug ◽  
Review Of The Literature ◽  
Single Center ◽  
The Real ◽  
Single Center Experience ◽  
Real Life Setting

Su2028 - Therapeutic Drug Monitoring of Infliximab During Induction: A Single-Center Experience

2018 ◽  
Vol 154 (6) ◽  
pp. S-671
Author(s):  
Jenna Diaz ◽  
Yasemin Cagil ◽  
Sneha Kolli ◽  
Alejandro Frade Garcia ◽  
Weize Wang ◽  
...  
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Therapeutic Drug ◽  
Single Center ◽  
Single Center Experience

scholarly journals Su1044 COLON CLEANSING EFFICACY AND SAFETY OF 1L PEG SOLUTION NER1006 IN A REAL-LIFE SETTING: A SINGLE CENTER EXPERIENCE IN MADRID, SPAIN

2020 ◽  
Vol 91 (6) ◽  
pp. AB280
Author(s):  
Elena Perez Arellano ◽  
Maria Isabel Rodriguez Garcia ◽  
Ana Belen Galera Rodena ◽  
Emilio de la Morena Madrigal
Keyword(s):  
Real Life ◽  
Efficacy And Safety ◽  
Single Center ◽  
Colon Cleansing ◽  
Single Center Experience ◽  
Real Life Setting

Posaconazole Prophylaxis in Patients Undergoing Chemotherapy for Acute Myeloid Leukemia: A Single Center Experience of Therapeutic Drug Monitoring.

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2595-2595 ◽  
Author(s):  
Laura Pavan ◽  
Arianna Loregian ◽  
Angela Maria Quinto ◽  
Speranza Antonia Di Maggio ◽  
Silvana Pagni ◽  
...  
Keyword(s):  
Liquid Chromatography ◽  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Salvage Therapy ◽  
Plasma Concentrations ◽  
Response To Therapy ◽  
Therapeutic Drug ◽  
Single Center ◽  
Breakthrough Infection ◽  
Acute Myeloid

Abstract Abstract 2595 Background: Posaconazole is indicated for prophylaxis and salvage therapy of invasive fungal infections. Based on pharmacokinetic-pharmacodynamic data, a minimum serum concentration higher than 0.5 mg/L and 1.0 mg/L has been proposed for prophylaxis and therapy, respectively. While therapeutic drug monitoring (TDM) of plasma concentrations is widely accepted for triazole antifungal agents such as voriconazole, the utility of TDM for posaconazole is controversial due to debate over the relationship between posaconazole exposure in plasma and clinical response to therapy. In fact only few reports correlate posaconazole plasma concentrations (PPCs) with breakthrough infection. Methods: In this retrospective single center study we evaluated the correlation of PPCs with breakthrough invasive mould infections (IMIs) in 50 patients with acute myeloid leukaemia (AML) who underwent chemoterapy (induction or salvage therapy) between July 2009 and March 2012. To measure the posaconazole concentration in human plasma, we developed and validated a rapid and simple high-performance liquid chromatography method. The method involved a solid-phase extraction of posaconazole using Oasis HLB cartridges, a reversed-phase liquid chromatography on an XTerra RP18 column with a mobile phase consisting of acetonitrile/ammonium acetate and ultraviolet detection. Patient characteristics and microbiological data such galactomannan detection and TDM were collected retrospectively. A total of 454 PPCs were measured before and 4 hours after administration in 50 patients with AML receiving posaconazole prophylaxis at dose of 200 mg 3 times/day. When plasma levels were below 0.5 mg/L, the dose was increased to 200 mg 4 times/day. Results: Average levels below the target of 0.5 μg/mL were detected in 38 (76%) out of 50 cases; 5 out of 38 cases showed plasma concentrations <0.20 μg/mL. Six patients (12%) receiving PCZ prophylaxis met the criteria of breakthrough infection (5 possible and 1 probable). Noteworthy, none of these patients achieved a complete remission after chemotherapy. Prior to development of IMIs, PPCs were below the target in 4 out of 6 (66%) cases experiencing breakthrough infection (between 0.2 and 0.5 μg/mL). Interestingly, only one patient had galactomannan positivity in the bronchoalveolar lavage fluid whereas none of the cases had serum galactomannan. Furthermore, out of 13 patients with resistant disease who did not develop IMIs, 8 (62%) presented PCPs < 0.5 μg/mL. Conclusions: Our data demonstrate that low PPCs are common in patients receiving posaconazole prophylaxis during chemotherapy for AML. However, in spite of low PPCs, the rate of IMIs was low. This is possibly due to the good lung bioavailability of the drug, despite the presence of low drug serum levels. In addition, our data seems to confirm that refractory disease is a strong risk factor for the development of IMIs. Even in this high risk group, low PPCs did not correlate with high IMIs' incidence. A prospective evaluation of TDM of posaconazole is needed. Disclosures: No relevant conflicts of interest to declare.

Concomitant intake of abiraterone and food to increase pharmacokinetic exposure: Real-life data from a therapeutic drug monitoring program.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 3117-3117 ◽  
Author(s):  
Stefanie L. Groenland ◽  
Andre M. Bergman ◽  
Alwin Huitema ◽  
Neeltje Steeghs
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Monitoring Program ◽  
Real Life ◽  
Progression Free Survival ◽  
Abiraterone Acetate ◽  
Fixed Dose ◽  
Therapeutic Drug ◽  
Castration Resistant Prostate Cancer ◽  
Regular Treatment

3117 Background: Abiraterone acetate is registered for the treatment of metastatic castration resistant prostate cancer. Pharmacokinetic (PK) exposure has been linked to efficacy, since patients with Cmin ≥ 8.4 ng/mL have a significantly longer progression free survival compared to patients with a Cmin below this threshold (7.4 vs. 12.2 months, p = 0.044) (Carton, 2017). At the recommended fixed dose of 1000 mg QD administered in a modified fasting state, 35% of patients do not reach this efficacy threshold (Carton, 2017), providing a strong rationale for therapeutic drug monitoring (TDM). Since a clinically relevant food effect has been established, concomitant intake of abiraterone and food could offer a cost-neutral solution in case of low exposure (Chi, 2015). This study aims to evaluate whether PK-guided abiraterone dosing is feasible and results in an increased proportion of patients with concentrations above the target. Methods: Patients starting regular treatment with abiraterone were included. PK sampling occurred 4, 8 and 12 weeks after start of treatment, and every 12 weeks thereafter. Abiraterone concentrations were measured and Cmin was calculated. In case of Cmin < 8.4 ng/mL and acceptable toxicity, a PK-guided intervention was advised. As a first step, concomitant intake of abiraterone and a light meal or a snack was advised. Results: In total, 35 patients were included, of which 18 patients (51%) had at least one Cmin < 8.4 ng/mL. These patients were advised to take abiraterone concomitantly with food, after which Cmin increased significantly from 5.6 (47%) ng/mL [mean (CV%)] to 40.6 (110%) ng/mL (p = 0.006) without additional toxicities. This intervention led to adequate exposure in 15 patients (83%). Seventeen patients had all Cmin levels ≥ 8.4 ng/mL, in these patients mean Cmin was 31.5 (65%) ng/mL. Conclusions: TDM of abiraterone was applied in clinical practice and proved to be feasible. Concomitant intake with food resulted into a significant increase in Cmin and offers a cost-neutral opportunity to optimize treatment for patients with low PK exposure. Up to 100 patients will be included to evaluate the effect of PK-guided abiraterone dosing on treatment efficacy. Clinical trial information: NL6695.

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