Nemonoxacin dosage adjustment in patients with severe renal impairment based on population pharmacokinetic and pharmacodynamic analysis

Li, Yang; Lu, Jianda; Kang, Yu; Xu, Xiaoyong; Li, Xin; Chen, Yuancheng; Wang, Kun; Liu, Xiaofen; Fan, Yaxin; Wu, Haijiang; Wang, Yu; Hu, Jiali; Yu, Jingwei; Wu, Jiang; Guo, Beining; Zhang, Yingyuan; Zeng, Xin; Zhao, Ming; Xue, Jun; Zhang, Jing

doi:10.1111/bcp.14881

Cited by 5 publications

(1 citation statement)

References 20 publications

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“…Two PK studies on nemofloxacin showed a higher incidence of AEs in patients with mild and moderate hepatic or renal impairment with a creatinine clearance of ≥50 ml/min compared with the healthy population. Yet, they showed good tolerability and safety profiles of oral single-dose 500 mg nemonoxacin (Table 4) (Xiaoyong et al, 2020;Li et al, 2021). Study drug-related AEs manifested as Q-T interval prolongation, T wave change, white blood cell count decrease, total bilirubin increase, and skin pruritus, all of which were mild and transient, and the patients recovered without any treatment.…”

Section: Patients With Renal or Hepatic Impairmentmentioning

confidence: 99%

Safety of oral nemonoxacin: A systematic review of clinical trials and postmarketing surveillance

et al. 2022

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Background: Postmarketing safety analysis is an effective supplement for new drugs in clinical practice. Therefore, we aimed to systematically assess the safety of oral nemonoxacin malate, the first approved C-8-methoxy non-fluorinated quinolone, in clinical studies and via postmarketing safety surveillance.Methods: We electronically and manually searched and screened safety data (including premarketing and postmarketing data) of oral nemonoxacin from clinical registries. We standardized and summarized the reported adverse events according to the Medical Dictionary for Regulatory Activities System Organ Class and Preferred Terms. We summarized and reported the number and frequency (%) of the AEs and serious AEs in patients with community-acquired pneumonia and in specific patients.Results: Three Phase II/III comparator studies (n = 670, nemonoxacin), one Phase IV study (n = 461), two special population pharmacokinetic studies (n = 40), four observational studies (n = 1,852), and one 5-year postmarketing surveillance project (n = 257,420) were included in this study. The Phase II/III studies showed that the commonly reported drug-related AEs were similar for oral 500 mg nemonoxacin and levofloxacin treatments, which mainly included increased alanine aminotransferase levels (4.4% vs. 2.5%), neutropenia (2.5% vs. 4.4%), nausea (2.5% vs. 1.6%), and leukopenia (2.3% vs. 3.2%). No drug-related deaths were reported. Postmarketing safety surveillance revealed that known adverse drug reaction characteristics were generally unchanged. Pharmacokinetic data suggested that dose adjustment was not necessary in elderly patients, which was confirmed by a Phase IV study in an elderly population, in patients with renal impairment with CLcr ≥50 ml/min, and in those with mild-to-moderate hepatic impairment.Conclusion: Clinical trial data of approximately 1,450 patients and postmarketing data of >257,420 patients suggest that nemonoxacin is generally well tolerated and can be a suitable alternative to fluoroquinolones for patients with CAP.

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Section: Patients With Renal or Hepatic Impairmentmentioning

confidence: 99%

Safety of oral nemonoxacin: A systematic review of clinical trials and postmarketing surveillance

et al. 2022

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Current status and challenges of model-informed drug discovery and development in China

Wang,

Ji,

Yao

et al. 2024

Advanced Drug Delivery Reviews

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The Dosage Recommendation of Cyclosporin in Children with Hemophagocytic Lymphohistiocytosis based on Population Pharmacokinetic Model

Yang,

Li,

et al. 2023

CPD

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Objectives:: Cyclosporin is one of the therapeutic regimens for hemophagocytic lymphohistiocytosis (HLH); however, the optimal dosage of cyclosporine in children with HLH is unknown. It has been found that piperacillin-tazobactam affects the cyclosporine pharmacokinetic process in pediatric HLH patients. Thus, the purpose of the present study was to recommend cyclosporin dosage for pediatric HLH with and without piperacillin- tazobactam. Methods:: A previously established cyclosporine population pharmacokinetic model for pediatric HLH patients has been used in this study to recommend optimal dosage based on Monte Carlo simulation. The pediatric HLH patients have been included in eight weight groups (5, 10, 20, 30, 40, 50, 60, 70 kg) for sixteen dosages (1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 mg/kg), split into one dose or two doses. Results:: The optimal cyclosporin dosages for children having HLH without piperacillin-tazobactam have been found to be 15, 13, 12, 11, 10, and 9 mg/kg, split into two doses for weights of 5-7, 7-10, 10-20, 20-28, 28-45, and 45-70 kg, respectively. For children with HLH, optimal cyclosporin dosages with piperacillin-tazobactam have been found to be 8 and 7 mg/kg, split into two doses for weights of 5-20 and 20-70 kg, respectively. Conclusion: It is the first time that the cyclosporin dosage regimens for HLH in children have been developed based on Monte Carlo simulation, and the initial dosage optimizations of cyclosporine in pediatric HLH patients have been recommended.

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Nemonoxacin dosage adjustment in patients with severe renal impairment based on population pharmacokinetic and pharmacodynamic analysis

Cited by 5 publications

References 20 publications

Safety of oral nemonoxacin: A systematic review of clinical trials and postmarketing surveillance

Safety of oral nemonoxacin: A systematic review of clinical trials and postmarketing surveillance

Current status and challenges of model-informed drug discovery and development in China

The Dosage Recommendation of Cyclosporin in Children with Hemophagocytic Lymphohistiocytosis based on Population Pharmacokinetic Model

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