Concomitant intake of abiraterone acetate and food to increase pharmacokinetic exposure: real life data from a therapeutic drug monitoring programme

2020 ◽  
Vol 130 ◽  
pp. 32-38 ◽  
Author(s):  
Stefanie L. Groenland ◽  
Merel van Nuland ◽  
Andries M. Bergman ◽  
Jeantine M. de Feijter ◽  
Vincent O. Dezentje ◽  
...  
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Real Life ◽  
Abiraterone Acetate ◽  
Monitoring Programme ◽  
Therapeutic Drug ◽  
Life Data ◽  
Real Life Data

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.

scholarly journals Real-life isoniazid and rifampicin plasma concentrations in children: a tool for therapeutic drug monitoring of tuberculosis

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Chiara Tersigni ◽  
Giulia Boiardi ◽  
Lorenzo Tofani ◽  
Elisabetta Venturini ◽  
Carlotta Montagnani ◽  
...  
Keyword(s):  
Plasma Concentration ◽  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Venous Blood ◽  
Plasma Concentrations ◽  
Age Groups ◽  
Real Life ◽  
Therapeutic Drug ◽  
Blood Samples ◽  
Drug Concentrations

Abstract Background Low plasma levels of first-line antitubercular drugs can be counted among the main causes of poor response to antitubercular therapy, and therapeutic drug monitoring has been proposed as a method to promote tailored treatments for both child and adult patients. The main aim of the study was to evaluate serum concentrations of isoniazid (INH) and rifampicin (RIF) and to investigate reasons for sub-therapeutic plasma concentrations in order to fix dosages. Methods Children with TB were prospectively enrolled from January to August 2019. Two venous blood samples were collected (the first at least 15 days after the beginning of antitubercular treatment, and the second between 1 and 8 weeks later). Plasma concentrations were determined by a validated high-performance liquid chromatography method. Results In all, 45 children were included. Seventy blood samples for INH plasma concentration were collected between 120 and 240 min after drug intake. Adjusting for dose (mg/kg/day) and time of INH administration, when considering three different age groups (≤ 2 years, 2–12 years, > 12 years), a statistically significant lower INH plasma concentration was observed in younger children compared to the older age groups in the multivariate analysis (p < 0.001 and p < 0.001). A total of 68 blood samples were evaluated for RIF concentrations. Both for INH and RIF a statistically significant lower plasma concentration was also observed in adolescents (p < 0.001). Fifteen children (15/45, 33%) presented drug concentrations under the referral therapeutic range. Conclusions Based on our findings, monitoring patients’ drug plasma concentrations in children under 2 years of age and in adolescents can make treatment more patient-tailored.

scholarly journals ‘Therapeutic drug monitoring of posaconazole delayed release tablet while managing COVID‐19 associated mucormycosis in a real‐life setting’

Mycoses ◽  
2021 ◽  
Author(s):  
Atul K Patel ◽  
Ketan K Patel ◽  
Kamlesh Patel ◽  
Kinjal Shah ◽  
Arunaloke Chakrabarti
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Real Life ◽  
Therapeutic Drug ◽  
Delayed Release ◽  
Real Life Setting ◽  
Release Tablet

scholarly journals A retrospective study on therapeutic drug monitoring of mood stabilizers in real-life clinical scenario

2020 ◽  
Vol 12 (3) ◽  
pp. 351
Author(s):  
JishaM Lucca ◽  
Hawra Abu-Qurain ◽  
Fatimah Almashhad ◽  
Mahdi Saeed Abumadini
Keyword(s):  
Retrospective Study ◽  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Real Life ◽  
Mood Stabilizers ◽  
Therapeutic Drug ◽  
Clinical Scenario

Therapeutic drug monitoring of second-generation antipsychotics in pediatric patients: an observational study in real-life settings

2015 ◽  
Vol 72 (3) ◽  
pp. 285-293 ◽  
Author(s):  
Marco Pozzi ◽  
Dario Cattaneo ◽  
Sara Baldelli ◽  
Serena Fucile ◽  
Annalisa Capuano ◽  
...  
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Observational Study ◽  
Drug Monitoring ◽  
Second Generation ◽  
Pediatric Patients ◽  
Real Life ◽  
Therapeutic Drug ◽  
Second Generation Antipsychotics

Fosfomycin therapeutic drug monitoring in real-life: development and validation of a LC-MS/MS method on plasma samples

2021 ◽  
pp. 1-10
Author(s):  
Sara Baldelli ◽  
Matteo Cerea ◽  
Davide Mangioni ◽  
Laura Alagna ◽  
Antonio Muscatello ◽  
...  
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Real Life ◽  
Therapeutic Drug ◽  
Plasma Samples ◽  
Development And Validation

scholarly journals A Non-Invasive Method for Detection of Antihypertensive Drugs in Biological Fluids: The Salivary Therapeutic Drug Monitoring

2022 ◽  
Vol 12 ◽  
Author(s):  
Valeria Avataneo ◽  
Elvira Fanelli ◽  
Amedeo De Nicolò ◽  
Franco Rabbia ◽  
Alice Palermiti ◽  
...  
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Antihypertensive Drugs ◽  
Biological Fluids ◽  
Real Life ◽  
European Medicines Agency ◽  
Therapeutic Drug ◽  
Hypertensive Patients ◽  
Non Invasive ◽  
Target Values

Objectives: Arterial hypertension is still the most frequent cause of cardiovascular and cerebrovascular morbidity and mortality. Antihypertensive treatment has proved effective in reduction of cardiovascular risk. Nevertheless, lifestyle interventions and pharmacological therapy in some cases are ineffective in reaching blood pressure target values, despite full dose and poly-pharmacological treatment. Poor adherence to medications is an important cause of treatment failure. Different methods to assess therapeutic adherence are currently available: Therapeutic drug monitoring in biological fluids has previously demonstrated its efficacy and reliability. Plasma and urine have been already used for this purpose, but they may be affected by some practical limitations. Saliva may represent a feasible alternative.Methods: Fourteen antihypertensive drugs and two metabolites were simultaneously tested in plasma, urine, and saliva. Tested molecules included: atenolol, nebivolol, clonidine, ramipril, olmesartan, telmisartan, valsartan, amlodipine, nifedipine, doxazosin, chlorthalidone, hydrochlorothiazide, indapamide, sacubitril, ramiprilat, and sacubitrilat. Therapeutic drug monitoring was performed using ultra-high performance liquid chromatography, coupled to tandem mass spectrometry (UHPLC-MS/MS). The method has been preliminarily evaluated in a cohort of hypertensive patients.Results: The method has been validated according to US Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines. The application on a cohort of 32 hypertensive patients has demonstrated sensibility and specificity of 98% and 98.1%, respectively, with a good feasibility in real-life clinical practice.Conclusion: Saliva may represent a feasible biological sample for therapeutic drug monitoring by non-invasive collection, prompt availability, and potential accessibility also in out-of-clinic settings.

Therapeutic drug monitoring and pharmacogenetics of antipsychotics and antidepressants in real life settings: A 5-year single centre experience

2020 ◽  
pp. 1-12
Author(s):  
Sara Baldelli ◽  
Stefania Cheli ◽  
Cristina Montrasio ◽  
Dario Cattaneo ◽  
Emilio Clementi
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Real Life ◽  
Therapeutic Drug ◽  
Single Centre ◽  
Single Centre Experience

scholarly journals P569 Outcomes of IBD patients treated with infliximab: The impact of therapeutic drug monitoring in real-life clinical practice

2018 ◽  
Vol 12 (supplement_1) ◽  
pp. S394-S394
Author(s):  
N Kamperidis ◽  
P Middleton ◽  
T Tyrrell ◽  
I Stasinos ◽  
N Arebi
Keyword(s):  
Clinical Practice ◽  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Real Life ◽  
Therapeutic Drug ◽  
The Impact

scholarly journals A 3‐year prospective study of a multidisciplinary early proactive therapeutic drug monitoring programme of infliximab treatments in inflammatory bowel disease

2020 ◽  
Vol 86 (6) ◽  
pp. 1165-1175 ◽  
Author(s):  
José Germán Sánchez‐Hernández ◽  
Noemí Rebollo ◽  
Ana Martin‐Suarez ◽  
M. Victoria Calvo ◽  
Fernando Muñoz
Keyword(s):  
Inflammatory Bowel Disease ◽  
Therapeutic Drug Monitoring ◽  
Prospective Study ◽  
Bowel Disease ◽  
Drug Monitoring ◽  
Monitoring Programme ◽  
Therapeutic Drug ◽  
Inflammatory Bowel
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