Pharmacokinetics of intravenous telavancin in healthy subjects with varying degrees of renal impairment.
Purpose: We evaluated the effect of renal impairment (RI) on the pharmacokinetics of telavancin and hydroxypropylbetadex (excipient in the telavancin drug product). Methods: Adults with normal, mild, moderate or severe RI or end-stage renal disease (ESRD) receiving haemodialysis were included in two...
| Publicado en: | European Journal of Clinical Pharmacology Vol. 71; no. 6; pp. 707 - 715 |
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| Autores principales: | , , |
| Formato: | equations & formulas research tables/charts Journal Article |
| Publicado: |
Springer Nature
Jun2015
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=103797778&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 103797778 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00316970 NP9 jtl: European Journal of Clinical Pharmacology issn: 00316970 maglogo: N pubinfo: dt: Jun2015 vid: 71 iid: 6 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 103797778 102643867 10.1007/s00228-015-1847-6 NLM25939708 PMC4430595 103797778 ppf: 707 ppct: 8 formats: fmt: @attributes: type: P tig: atl: Pharmacokinetics of intravenous telavancin in healthy subjects with varying degrees of renal impairment. aug: au: Worboys, Philip Wong, Shekman Barriere, Steven affil: Theravance Biopharma US, Inc., 901 Gateway Boulevard South San Francisco 94080 USA sug: subj: Administration, Intravenous Antibiotics Pharmacokinetics Kidney Diseases Dialysis Patients Human Male Female Young Adult Adult Middle Age Aged Poland Antibiotics Blood Antibiotics Urine Post Hoc Analysis Descriptive Statistics Adverse Drug Event Adult: 19-44 years Middle Aged: 45-64 years Aged: 65+ years Male Female ab: Purpose: We evaluated the effect of renal impairment (RI) on the pharmacokinetics of telavancin and hydroxypropylbetadex (excipient in the telavancin drug product). Methods: Adults with normal, mild, moderate or severe RI or end-stage renal disease (ESRD) receiving haemodialysis were included in two open-label, phase I studies of single-dose telavancin at 7.5 mg/kg (study A, n = 29) or 10 mg/kg (study B, n = 43). Pharmacokinetic analysis of telavancin and hydroxypropylbetadex plasma concentration versus time was performed in these subjects. Results: The results in studies A and B were similar: telavancin systemic exposure (area under the concentration-time curve from 0 to infinity [AUC]) increased with RI. Telavancin half-life ( h, mean ± SD) increased in subjects with severe RI compared with subjects with normal renal function from 6.9 ± 0.6 in study A and 6.5 ± 0.9 in study B to 14.5 ± 1.3 and 11.8 ± 6.7, respectively. Conversely, clearance (ml/h/kg, mean ± SD) decreased in subjects with severe RI compared with subjects with normal renal function from 13.7 ± 2.1 in study A and 17.0 ± 3.2 in study B to 6.18 ± 0.63 and 6.5 ± 1.5, respectively. Systemic exposures for hydroxypropylbetadex also increased with severity of RI. Conclusions: Results from two independent phase 1 studies suggest that dose adjustment of telavancin is required in subjects with varying degrees of RI. pubtype: Academic Journal doctype: equations & formulas research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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