Clinical practice guidelines for therapeutic drug monitoring of arbekacin: A consensus review of the Japanese Society of Chemotherapy and the Japanese Society of Therapeutic Drug Monitoring

Abstract

Arbekacin (ABK) was approved and widely used in Japan for treatment of patients infected with MRSA, and TDM was introduced in clinical practice. The Japanese Society of Chemotherapy and the Japanese Society of Therapeutic Drug Monitoring decided to develop a clinical practice guidelines for TDM of ABK for the following reasons. First, although the daily dose of 150-200 mg was approved in Japan, recent PK-PD studies revealed that higher serum concentration is required to achieve better clinical efficacy and several findings concerning the usefulness of higher dosage regimen have obtained recently. Second, although maximal concentrations that obtained immediately after the end of administration (Cmax) was generally adopted, the serum concentration at 1 h after initiation of administration [peak serum concentration (Cpeak)] proved to be more suitable as an efficacy indicator of aminoglycosides. Lastly, as ABK is approved only in Japan, no international practice guideline for TDM has not been available in ABK to date. This guideline evaluated the scientific data associated with serum ABK monitoring and provided recommendations based on the available evidence. Potential limitations of this guideline, however, include the findings that few prospective clinical trials of TDM of ABK are available in the treatment of MRSA infections and that most of the published literature describes observational studies.

Detection of KRAS mutations in circulating tumor cells from patients with metastatic colorectal cancer

“…Thus, only wild-type RAS (KRAS and NRAS) patients can receive anti-EGFR therapy for mCRC, according to Treatment Guidelines for CRC published by the National Comprehensive Cancer Network (NCCN), European Society for Medical Oncology (ESMO) and Japanese Society for Cancer of the Colon and Rectum (JSCCR). 8 Metastatic process is dynamic, so, longitudinal monitoring of CTCs can provide a noninvasive and real time evaluation of potential biomarkers related to resistance to specific target therapies.…”

Population pharmacokinetics of arbekacin in different infectious disease settings and evaluation of dosing regimens

“…First, this study was retrospective. Regard to the limitation, our study did not evaluated ideal body weight as covariate on CL and V, while previous studies and guidelines recommended to consider the ideal body weight (and BMI) for adjustment of aminoglycoside dosage [9,19]. Additionally, we did not calculate CCr with ideal body weight instead of actual body weight.…”

“…The clinical guidelines for TDM of arbekacin by the Japanese Society of Chemotherapy (JSC) and the Japanese Society of TDM (JSTDM) suggest that arbekacin should initially be administered at 4e6 mg/kg (dosing interval: 12, 24, or 48 h), and the dose interval should be adjusted based on TDM results, targeting 9e20 mg/mL of Cpeak and <2 mg/ mL of Ctrough. Furthermore, some experts have suggested that a target Cpeak of 15e20 mg/mL is recommended, especially for patients harbouring severe infections [9].…”

Clinical Evaluation of Pharmacist Interventions in Patients Treated with Anti-methicillin-Resistant <i>Staphylococcus aureus</i> Agents in a Hematological Ward

“…10) No patients in this survey were diagnosed with severe infection and the optimal concentrations were defined as: VCM and TEIC, trough concentration of 10-20 µg/mL; ABK, trough concentration of <2.0 µg/ mL and peak concentration of 9-20 µg/mL. [11][12][13] Achievement was recorded if the optimal drug concentration was reached once during treatment. We checked the incidence of acute renal injury, defined as an increase in serum creatinine to ≥1.5 times baseline after drug administration.…”