scholarly journals Valganciclovir—Ganciclovir Use and Systematic Therapeutic Drug Monitoring. An Invitation to Antiviral Stewardship

Antibiotics ◽  
2021 ◽  
Vol 10 (1) ◽  
pp. 77
Author(s):  
Alicia Galar ◽  
Maricela Valerio ◽  
Pilar Catalán ◽  
Xandra García-González ◽  
Almudena Burillo ◽  
...  
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
High Performance ◽  
Initial Dosage ◽  
Serum Levels ◽  
Individual Variability ◽  
Therapeutic Drug ◽  
Drug Discontinuation ◽  
Tertiary Institution ◽  
Treatment Adequacy

Valganciclovir (VGCV) and ganciclovir (GCV) doses must be adjusted according to indication, renal function and weight. No specific therapeutic exposure values have been established. We aimed to evaluate the adequacy of VGCV/GCV doses, to assess the interpatient variability in GCV serum levels, to identify predictive factors for this variability and to assess the clinical impact. This is a prospective study at a tertiary institution including hospitalized patients receiving VGCV/GCV prophylaxis or treatment. Adequacy of the antiviral dose was defined according to cytomegalovirus guidelines. Serum levels were determined using High-Performance Liquid Chromatography. Blood samples were drawn at least 3 days after antiviral initiation. Outcome was considered favorable if there was no evidence of cytomegalovirus infection during prophylaxis or when a clinical and microbiological resolution was attained within 21 days of treatment and no need for drug discontinuation due to toxicity. Seventy consecutive patients [74.3% male/median age: 59.2 years] were included. VGCV was used in 25 patients (35.7%) and GCV in 45 (64.3%). VGCV/GCV initial dosage was deemed adequate in 47/70 cases (67.1%), lower than recommended in 7/70 (10%) and higher in 16/70 (22.9%). Large inter-individual variability of serum levels was observed, with median trough levels of 2.3 mg/L and median peak levels of 7.8 mg/L. Inadequate dosing of VGCV/GCV and peak levels lower than 8.37 or greater than 11.86 mg/L were related to poor outcome. Further studies must be performed to confirm these results and to conclusively establish if VGCV/GCV therapeutic drug monitoring could be useful to improve outcomes in specific clinical situations.

scholarly journals Implementation and Comparison of Two Pharmacometric Tools for Model-Based Therapeutic Drug Monitoring and Precision Dosing of Daptomycin

Pharmaceutics ◽  
2022 ◽  
Vol 14 (1) ◽  
pp. 114
Author(s):  
Justine Heitzmann ◽  
Yann Thoma ◽  
Romain Bricca ◽  
Marie-Claude Gagnieu ◽  
Vincent Leclerc ◽  
...  
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Joint Infection ◽  
Significant Proportion ◽  
Initial Dosage ◽  
Validation Dataset ◽  
Therapeutic Drug ◽  
Efficacy And Safety ◽  
Absolute Percent Error ◽  
Better Than

Daptomycin is a candidate for therapeutic drug monitoring (TDM). The objectives of this work were to implement and compare two pharmacometric tools for daptomycin TDM and precision dosing. A nonparametric population PK model developed from patients with bone and joint infection was implemented into the BestDose software. A published parametric model was imported into Tucuxi. We compared the performance of the two models in a validation dataset based on mean error (ME) and mean absolute percent error (MAPE) of individual predictions, estimated exposure and predicted doses necessary to achieve daptomycin efficacy and safety PK/PD targets. The BestDose model described the data very well in the learning dataset. In the validation dataset (94 patients, 264 concentrations), 21.3% of patients were underexposed (AUC24h < 666 mg.h/L) and 31.9% of patients were overexposed (Cmin > 24.3 mg/L) on the first TDM occasion. The BestDose model performed slightly better than the model in Tucuxi (ME = −0.13 ± 5.16 vs. −1.90 ± 6.99 mg/L, p < 0.001), but overall results were in agreement between the two models. A significant proportion of patients exhibited underexposure or overexposure to daptomycin after the initial dosage, which supports TDM. The two models may be useful for model-informed precision dosing.

scholarly journals Comparison of vancomycin serum levels prior to and post therapeutic drug monitoring in patients admitted to hospital

2021 ◽  
Vol 37 (3) ◽  
pp. 187-192
Author(s):  
Kaveh Eslami ◽  
Sasan Moogah ◽  
Reza Ganji ◽  
Farhad Najmeddin ◽  
Sorour Moogahi
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Serum Levels ◽  
Therapeutic Drug

Management of Chronic Myelogenous Leukemia Using Therapeutic Drug Monitoring of Imatinib: The French Experience of a Centralized Laboratory

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 3222-3222
Author(s):  
Mathieu Molimard ◽  
Stephane Bouchet ◽  
Gabriel Etienne ◽  
Laurence Legros ◽  
Delphine Rea ◽  
...  
Keyword(s):  
Plasma Concentration ◽  
Therapeutic Drug Monitoring ◽  
Sex Ratio ◽  
Chronic Myelogenous Leukemia ◽  
Drug Monitoring ◽  
Individual Variability ◽  
Myelogenous Leukemia ◽  
Therapeutic Drug ◽  
Efficient Treatment ◽  
Trough Plasma

Abstract Pharmacokinetic monitoring is widely used in different medical specialities, but it has been rarely applied in clinical oncology practice. The current gold standard treatment of chronic myelogenous leukemia (CML) is imatinib, a tyrosine kinase inhibitor. We have previously shown the necessity to obtain a trough plasma threshold of 1000 ng/mL for efficient treatment with imatinib. We routinely perform centralized quantification for patients in France and this has allowed the assessment of imatinib therapeutic monitoring and its use in a real-life setting. After 16 months of data collection, we had gathered 1607 samples for 1044 CML patients (mean age 55 years, F/M sex ratio 0.67) treated with imatinib 400 mg (median) range (100–800mg). We received only one sample for 739 patients and more than one sample for 305 patients. The mean trough plasma concentration of imatinib (Cmin) was 1043 ng/mL (median: 876 ng/mL) and 596 of the 1044 CML patients (57%) had a Cmin &lt;1000ng/ml at first determination. Plasma concentration increased with dose, but there was a large inter-individual variability (64%) and intra-individual variability was twice as small. For plasma concentrations &lt; 1000 ng/mL, mean dose was 420 mg and for those ≥ 1000 ng/mL, this was 510 mg. For the 189 patients having had at least 2 correct Cmin determination, 70% had initial Cmin&lt; 1000 ng/mL (mean concentration of 1st determination: 583 ng/mL). Among the 62 patients who initially had a Cmin below 1000 ng/mL that subsequently rose above this threshold, 63% had their imatinib dose increased; the rest did not have a dose modification. For the latter, it is probable in view of low intra-individual variability that this was due to enhanced compliance. For the 32 patients with a first Cmin &lt;1000 and no CCyR, none of those with Cmin remaining below 1000 ng/mL achieved CCyR, wheras 5 (28%) achieved CCyR when Cmin rose above 1000 ng/mL. In cases where there was suspicion of a drug–drug interaction, the most frequently combined drugs were proton pump inhibitors (such as omeprazole), diuretics, allopurinol and NSAIDs. The most recurrent adverse effects were digestive, hematological and muscular. Although the studied population had characteristics generally described for this pathology (age, sex ratio), there was probably selection bias at the beginning of study: we received first and foremost the patients having an insufficient response, and therefore low plasma concentration. Therapeutic drug monitoring of imatinib appears to be helpful for the management of CML patients and the resulting database allows a better understanding and use of this treatment.

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