Dosing Recommendations for Pediatric Patients With Renal Impairment

Al-khouja, Amer; Park, Kyunghun; Anderson, Daijha J.C.; Young, Caitlyn; Wang, Jian; Huang, Shiew Mei; Khurana, Mona; Burckart, Gilbert J.

doi:10.1002/jcph.1676

Cited by 7 publications

(10 citation statements)

References 96 publications

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“…As shown in Table 3, all nine patients were treated for CMV with oral valganciclovir 14mg/kg twice daily. Doses may be renally adjusted, which occurred in one patient 9 . Of those nine, six (66.6%) received valganciclovir only for the treatment of CMV.…”

Section: Resultsmentioning

confidence: 99%

Valganciclovir for the treatment of cytomegalovirus infections in pediatric intestinal transplant recipients: A case series

Henry

Leick

Florescu

et al. 2021

Pediatric Transplantation

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Background Cytomegalovirus (CMV) is the most common opportunistic infection post‐transplant and is associated with significant morbidity and mortality. Currently, there are no FDA dosing recommendations for the use of valganciclovir for the treatment of CMV infections in pediatric patients. This case series describes the use of valganciclovir for the treatment of CMV infections in nine pediatric intestinal transplant recipients (pITR). Methods Retrospective review of pITR between January 2004 and December 2016. The primary outcome was resolution of CMV viremia. Secondary outcomes included time‐to‐resolution of viremia, relapse rate, incidence of resistance, hematologic adverse effects, rejection, graft loss, and death. Results Of 214 pITR, ten CMV infections were treated with valganciclovir. One patient was lost to follow‐up while on treatment and was not included. Eight (89%) patients had resolution of CMV viremia. The average dose of valganciclovir was 14.3mg/kg (SD 0.82) twice daily. CMV resistance testing was completed in three (33.3%) patients; one patient had a documented mutation requiring leflunomide to clear viremia. Three (33.3%) patients experienced rejection within one month prior to or during treatment for CMV. Six (66.6%) experienced hematologic side effects. No patients died or experienced graft loss. Conclusion This is the first study to assess the use of valganciclovir for the treatment of CMV in pITR. Based on these results, weight‐based dosing of valganciclovir seems to be an appropriate option for the treatment of CMV in pITR. Given limited number of patients reviewed in this case series and the high incidence of hematologic side effects, further investigation is warranted.

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Section: Resultsmentioning

confidence: 99%

Valganciclovir for the treatment of cytomegalovirus infections in pediatric intestinal transplant recipients: A case series

Henry

Leick

Florescu

et al. 2021

Pediatric Transplantation

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“…One of the best examples of a need for dosing information in a specific pediatric patient population is the lack of current recommendations for pediatric dosing in renal impairment. A recent review of the evidentiary standards for those recommendations in a standard Wolters‐Kluwer Lexicomp pediatric dosing handbook demonstrated that <25% of those pediatric renal impairment dosing recommendations have any clinical information to substantiate the recommendation 56 …”

Section: Filling the Gap For Dosing In Pediatric Drug Developmentmentioning

confidence: 99%

“…The application of the same adult renal dosing recommendations to pediatric patients based on adult renal impairment PK data is most common 56 . This method assumes similar proportional effects of renal impairment on PK between adults and pediatric patients, but often without observed pediatric data to validate this assumption.…”

Section: Filling the Gap For Dosing In Pediatric Drug Developmentmentioning

confidence: 99%

Progress in Drug Development–Pediatric Dose Selection: Workshop Summary

Wang

Anker

Burckart

2021

The Journal of Clinical Pharma

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“…Specific subpopulations are not addressed in pediatric anti-infective drugs development, such as children and neonates with kidney dysfunction or KRT. As pointed out in a recent review, clinical evidence in children does not exist for most renal dosing recommendations in a widely used pediatric dosing handbook, with the adult recommendations from the manufacturer's label being the primary source for pediatric dosing ( 4 ). Most studies on drug dosage in patients with kidney failure are performed in adults for ethical reasons, and off-label use is frequent in pediatrics.…”

Section: Introductionmentioning

confidence: 99%

Anti-infective Medicines Use in Children and Neonates With Pre-existing Kidney Dysfunction: A Systematic Review

et al. 2022

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BackgroundDosing recommendations for anti-infective medicines in children with pre-existing kidney dysfunction are derived from adult pharmacokinetics studies and adjusted to kidney function. Due to neonatal/pediatric age and kidney impairment, modifications in renal clearance and drug metabolism make standard anti-infective dosing for children and neonates inappropriate, with a risk of drug toxicity or significant underdosing. The aim of this study was the systematic description of the use of anti-infective medicines in pediatric patients with pre-existing kidney impairment.MethodsA systematic review of the literature was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The EMBASE, Medline and Cochrane databases were searched on September 21st, 2021. Studies in all languages reporting data on pre-defined outcomes (pharmacokinetics-PK, kidney function, safety and efficacy) regarding the administration of anti-infective drugs in children up to 18 years with pre-existing kidney dysfunction were included.Results29 of 1,792 articles were eligible for inclusion. There were 13 case reports, six retrospective studies, nine prospective studies and one randomized controlled trial (RCT), reporting data on 2,168 pediatric patients. The most represented anti-infective class was glycopeptides, with seven studies on vancomycin, followed by carbapenems, with five studies, mostly on meropenem. Antivirals, aminoglycosides and antifungals counted three articles, followed by combined antibiotic therapy, cephalosporins, lipopeptides with two studies, respectively. Penicillins and polymixins counted one study each. Nine studies reported data on patients with a decreased kidney function, while 20 studies included data on kidney replacement therapy (KRT). Twenty-one studies reported data on PK. In 23 studies, clinical outcomes were reported. Clinical cure was achieved in 229/242 patients. There were four cases of underdosing, one case of overdosing and 13 reported deaths.ConclusionThis is the first systematic review providing evidence of the use of anti-infective medicines in pediatric patients with impaired kidney function or requiring KRT. Dosing size or interval adjustments in pediatric patients with kidney impairment vary according to age, critical illness status, decreased kidney function and dialysis type. Our findings underline the relevance of population PK in clinical practice and the need of developing predictive specific models for critical pediatric patients.

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Dosing Recommendations for Pediatric Patients With Renal Impairment

Cited by 7 publications

References 96 publications

Valganciclovir for the treatment of cytomegalovirus infections in pediatric intestinal transplant recipients: A case series

Valganciclovir for the treatment of cytomegalovirus infections in pediatric intestinal transplant recipients: A case series

Progress in Drug Development–Pediatric Dose Selection: Workshop Summary

Anti-infective Medicines Use in Children and Neonates With Pre-existing Kidney Dysfunction: A Systematic Review

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