Pharmacokinetics of Zanamivir following Intravenous Administration to Subjects with and without Renal Impairment
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| Published in | Antimicrobial Agents and Chemotherapy Vol. 57; no. 7; pp. 2967 - 2971 |
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| Main Authors | , , , , |
| Format | Journal Article |
| Language | English |
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American Society for Microbiology
01.07.2013
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| ISSN | 0066-4804 1098-6596 1098-6596 |
| DOI | 10.1128/AAC.02330-12 |
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| AbstractList | Intravenous zanamivir is in clinical development for the treatment of influenza in hospitalized patients, many of whom have renal impairment. This open-label study evaluated zanamivir pharmacokinetics and clinical safety following a single 100-mg intravenous infusion dose in subjects with impaired renal function compared with normal renal function. Male and female subjects between 18 and 79 years of age were recruited, four subjects to each renal function group (normal function and mild, moderate, and severe impairment). Serial blood samples were collected up to 24 h after dose administration (48 h for the severe renal impairment group) to estimate zanamivir serum pharmacokinetic parameters. Urine was collected over the same 24-h (or 48-h) period for estimation of renal clearance (CL
R
). Zanamivir pharmacokinetics were assessed by regression analysis of systemic clearance (CL) and CL
R
as a function of creatinine clearance (CL
CR
). Safety evaluations included adverse-event monitoring, vital signs, electrocardiogram, and clinical laboratory assessments. Zanamivir clearance (total and renal) significantly decreased with decreasing renal function, with corresponding increases in area under the concentration-time curve and elimination half-life. Renal impairment had no apparent effects on peak concentration or volume of distribution. Regression analysis indicated that zanamivir clearance was highly correlated (
r
2
= 0.89) with creatinine clearance: CL ≅ 7.08 + 0.826 · CL
CR
. There were no patterns or trends in adverse events, and no new safety concerns were identified following administration of intravenous zanamivir. Results from this study support the inclusion of subjects with renal impairment, with appropriate dose adjustment, in studies to evaluate intravenous zanamivir in the treatment of influenza. Intravenous zanamivir is in clinical development for the treatment of influenza in hospitalized patients, many of whom have renal impairment. This open-label study evaluated zanamivir pharmacokinetics and clinical safety following a single 100-mg intravenous infusion dose in subjects with impaired renal function compared with normal renal function. Male and female subjects between 18 and 79 years of age were recruited, four subjects to each renal function group (normal function and mild, moderate, and severe impairment). Serial blood samples were collected up to 24 h after dose administration (48 h for the severe renal impairment group) to estimate zanamivir serum pharmacokinetic parameters. Urine was collected over the same 24-h (or 48-h) period for estimation of renal clearance (CLR). Zanamivir pharmacokinetics were assessed by regression analysis of systemic clearance (CL) and CLR as a function of creatinine clearance (CLCR). Safety evaluations included adverse-event monitoring, vital signs, electrocardiogram, and clinical laboratory assessments. Zanamivir clearance (total and renal) significantly decreased with decreasing renal function, with corresponding increases in area under the concentration-time curve and elimination half-life. Renal impairment had no apparent effects on peak concentration or volume of distribution. Regression analysis indicated that zanamivir clearance was highly correlated (r2 = 0.89) with creatinine clearance: CL approximately equal to 7.08 + 0.826 . CLCR. There were no patterns or trends in adverse events, and no new safety concerns were identified following administration of intravenous zanamivir. Results from this study support the inclusion of subjects with renal impairment, with appropriate dose adjustment, in studies to evaluate intravenous zanamivir in the treatment of influenza. Intravenous zanamivir is in clinical development for the treatment of influenza in hospitalized patients, many of whom have renal impairment. This open-label study evaluated zanamivir pharmacokinetics and clinical safety following a single 100-mg intravenous infusion dose in subjects with impaired renal function compared with normal renal function. Male and female subjects between 18 and 79 years of age were recruited, four subjects to each renal function group (normal function and mild, moderate, and severe impairment). Serial blood samples were collected up to 24 h after dose administration (48 h for the severe renal impairment group) to estimate zanamivir serum pharmacokinetic parameters. Urine was collected over the same 24-h (or 48-h) period for estimation of renal clearance (CLR). Zanamivir pharmacokinetics were assessed by regression analysis of systemic clearance (CL) and CLR as a function of creatinine clearance (CLCR). Safety evaluations included adverse-event monitoring, vital signs, electrocardiogram, and clinical laboratory assessments. Zanamivir clearance (total and renal) significantly decreased with decreasing renal function, with corresponding increases in area under the concentration-time curve and elimination half-life. Renal impairment had no apparent effects on peak concentration or volume of distribution. Regression analysis indicated that zanamivir clearance was highly correlated (r2 = 0.89) with creatinine clearance: CL ≅ 7.08 + 0.826 · CLCR. There were no patterns or trends in adverse events, and no new safety concerns were identified following administration of intravenous zanamivir. Results from this study support the inclusion of subjects with renal impairment, with appropriate dose adjustment, in studies to evaluate intravenous zanamivir in the treatment of influenza. Intravenous zanamivir is in clinical development for the treatment of influenza in hospitalized patients, many of whom have renal impairment. This open-label study evaluated zanamivir pharmacokinetics and clinical safety following a single 100-mg intravenous infusion dose in subjects with impaired renal function compared with normal renal function. Male and female subjects between 18 and 79 years of age were recruited, four subjects to each renal function group (normal function and mild, moderate, and severe impairment). Serial blood samples were collected up to 24 h after dose administration (48 h for the severe renal impairment group) to estimate zanamivir serum pharmacokinetic parameters. Urine was collected over the same 24-h (or 48-h) period for estimation of renal clearance (CLR). Zanamivir pharmacokinetics were assessed by regression analysis of systemic clearance (CL) and CLR as a function of creatinine clearance (CLCR). Safety evaluations included adverse-event monitoring, vital signs, electrocardiogram, and clinical laboratory assessments. Zanamivir clearance (total and renal) significantly decreased with decreasing renal function, with corresponding increases in area under the concentration-time curve and elimination half-life. Renal impairment had no apparent effects on peak concentration or volume of distribution. Regression analysis indicated that zanamivir clearance was highly correlated (r(2) = 0.89) with creatinine clearance: CL ≅ 7.08 + 0.826 · CLCR. There were no patterns or trends in adverse events, and no new safety concerns were identified following administration of intravenous zanamivir. Results from this study support the inclusion of subjects with renal impairment, with appropriate dose adjustment, in studies to evaluate intravenous zanamivir in the treatment of influenza.Intravenous zanamivir is in clinical development for the treatment of influenza in hospitalized patients, many of whom have renal impairment. This open-label study evaluated zanamivir pharmacokinetics and clinical safety following a single 100-mg intravenous infusion dose in subjects with impaired renal function compared with normal renal function. Male and female subjects between 18 and 79 years of age were recruited, four subjects to each renal function group (normal function and mild, moderate, and severe impairment). Serial blood samples were collected up to 24 h after dose administration (48 h for the severe renal impairment group) to estimate zanamivir serum pharmacokinetic parameters. Urine was collected over the same 24-h (or 48-h) period for estimation of renal clearance (CLR). Zanamivir pharmacokinetics were assessed by regression analysis of systemic clearance (CL) and CLR as a function of creatinine clearance (CLCR). Safety evaluations included adverse-event monitoring, vital signs, electrocardiogram, and clinical laboratory assessments. Zanamivir clearance (total and renal) significantly decreased with decreasing renal function, with corresponding increases in area under the concentration-time curve and elimination half-life. Renal impairment had no apparent effects on peak concentration or volume of distribution. Regression analysis indicated that zanamivir clearance was highly correlated (r(2) = 0.89) with creatinine clearance: CL ≅ 7.08 + 0.826 · CLCR. There were no patterns or trends in adverse events, and no new safety concerns were identified following administration of intravenous zanamivir. Results from this study support the inclusion of subjects with renal impairment, with appropriate dose adjustment, in studies to evaluate intravenous zanamivir in the treatment of influenza. Classifications Services AAC Citing Articles Google Scholar PubMed Related Content Social Bookmarking CiteULike Delicious Digg Facebook Google+ Mendeley Reddit StumbleUpon Twitter current issue AAC About AAC Subscribers Authors Reviewers Advertisers Inquiries from the Press Permissions & Commercial Reprints ASM Journals Public Access Policy AAC RSS Feeds 1752 N Street N.W. • Washington DC 20036 202.737.3600 • 202.942.9355 fax • journals@asmusa.org Print ISSN: 0066-4804 Online ISSN: 1098-6596 Copyright © 2014 by the American Society for Microbiology. For an alternate route to AAC .asm.org, visit: AAC Intravenous zanamivir is in clinical development for the treatment of influenza in hospitalized patients, many of whom have renal impairment. This open-label study evaluated zanamivir pharmacokinetics and clinical safety following a single 100-mg intravenous infusion dose in subjects with impaired renal function compared with normal renal function. Male and female subjects between 18 and 79 years of age were recruited, four subjects to each renal function group (normal function and mild, moderate, and severe impairment). Serial blood samples were collected up to 24 h after dose administration (48 h for the severe renal impairment group) to estimate zanamivir serum pharmacokinetic parameters. Urine was collected over the same 24-h (or 48-h) period for estimation of renal clearance (CLR). Zanamivir pharmacokinetics were assessed by regression analysis of systemic clearance (CL) and CLR as a function of creatinine clearance (CLCR). Safety evaluations included adverse-event monitoring, vital signs, electrocardiogram, and clinical laboratory assessments. Zanamivir clearance (total and renal) significantly decreased with decreasing renal function, with corresponding increases in area under the concentration-time curve and elimination half-life. Renal impairment had no apparent effects on peak concentration or volume of distribution. Regression analysis indicated that zanamivir clearance was highly correlated (r(2) = 0.89) with creatinine clearance: CL ≅ 7.08 + 0.826 · CLCR. There were no patterns or trends in adverse events, and no new safety concerns were identified following administration of intravenous zanamivir. Results from this study support the inclusion of subjects with renal impairment, with appropriate dose adjustment, in studies to evaluate intravenous zanamivir in the treatment of influenza. |
| Author | Yu Lou Lori S. Jones Amanda Peppercorn Judith Ng-Cashin Stephen Weller |
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| Keywords | Kidney disease Human Urinary system disease Intravenous administration Neuraminidase inhibitor Enzyme Enzyme inhibitor Zanamivir Glycosylases Nephropathy Exo-α-sialidase Glycosidases Renal failure Hydrolases Antiviral Pharmacokinetics |
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| References | e_1_3_2_7_2 e_1_3_2_6_2 e_1_3_2_5_2 e_1_3_2_4_2 e_1_3_2_3_2 e_1_3_2_2_2 22186145 - Lancet Infect Dis. 2012 Mar;12(3):240-8 10390212 - Antimicrob Agents Chemother. 1999 Jul;43(7):1616-20 22311680 - Antivir Ther. 2012;17(1 Pt B):159-73 10429836 - Clin Pharmacokinet. 1999;36 Suppl 1:13-9 10429835 - Clin Pharmacokinet. 1999;36 Suppl 1:1-11 Cass, LMR, Efthymiopoulos, C, Marsh, J, Bye, A (B4) 1999; 36 Nguyen, HT, Fry, AM, Gubareva, LV (B1) 2012; 17 B6 Hurt, AC, Chotpitayasunondh, T, Cox, NJ, Daniels, R, Fry, AM, Gubareva, LV, Hayden, FG, Hui, DS, Hungnes, O, Lackenby, A, Lim, W, Meijer, A, Penn, C, Tashiro, M, Uyeki, TM, Zambon, M (B2) 2012; 12 Cass, LMR, Efthymiopoulos, C, Bye, A (B3) 1999; 36 Calfee, DP, Peng, AW, Cass, LM, Lobo, M, Hayden, FG (B5) 1999; 43 |
| References_xml | – ident: e_1_3_2_5_2 doi: 10.2165/00003088-199936001-00002 – ident: e_1_3_2_3_2 doi: 10.1016/S1473-3099(11)70318-8 – ident: e_1_3_2_4_2 doi: 10.2165/00003088-199936001-00001 – ident: e_1_3_2_7_2 – ident: e_1_3_2_6_2 doi: 10.1128/AAC.43.7.1616 – ident: e_1_3_2_2_2 doi: 10.3851/IMP2067 – reference: 22311680 - Antivir Ther. 2012;17(1 Pt B):159-73 – reference: 10429836 - Clin Pharmacokinet. 1999;36 Suppl 1:13-9 – reference: 10390212 - Antimicrob Agents Chemother. 1999 Jul;43(7):1616-20 – reference: 22186145 - Lancet Infect Dis. 2012 Mar;12(3):240-8 – reference: 10429835 - Clin Pharmacokinet. 1999;36 Suppl 1:1-11 – volume: 12 start-page: 240 year: 2012 end-page: 248 ident: B2 article-title: Antiviral resistance during the 2009 influenza A H1N1 pandemic: public health, laboratory, and clinical perspectives publication-title: Lancet Infect. Dis – volume: 36 start-page: 1 year: 1999 end-page: 11 ident: B3 article-title: Pharmacokinetics of zanamivir after intravenous, oral, inhaled or intranasal administration to healthy volunteers publication-title: Clin. Pharmacokinet – volume: 36 start-page: 13 year: 1999 end-page: 19 ident: B4 article-title: Effect of renal impairment on the pharmacokinetics of intravenous zanamivir publication-title: Clin. Pharmacokinet – volume: 17 start-page: 159 year: 2012 end-page: 173 ident: B1 article-title: Neuraminidase inhibitor resistance in influenza viruses and laboratory testing methods publication-title: Antivir. Ther – volume: 43 start-page: 1616 year: 1999 end-page: 1620 ident: B5 article-title: Safety and efficacy of intravenous zanamivir in preventing experimental human influenza A virus infection publication-title: Antimicrob. Agents Chemother – ident: B6 article-title: Division of AIDS . 2004 . Division of AIDS table for grading the severity of adult and pediatric adverse events, version 1.0, December 2004 . Division of AIDS, NIAID, NIH , Bethesda, MD . http://www.niaid.nih.gov/LabsAndResources/resources/DAIDSClinRsrch/Documents/daidsaegradingtable.pdf . |
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| SubjectTerms | Adolescent Adult Aged Antibiotics. Antiinfectious agents. Antiparasitic agents Antiviral Agents Antiviral Agents - administration & dosage Antiviral Agents - adverse effects Antiviral Agents - pharmacokinetics Biological and medical sciences Creatinine - blood Creatinine - pharmacokinetics Creatinine - urine Female Humans Influenza, Human Influenza, Human - complications Influenza, Human - drug therapy Infusions, Intravenous Male Medical sciences Metabolic Clearance Rate Middle Aged Nephrology. Urinary tract diseases Nephropathies. Renovascular diseases. Renal failure Pharmacology. Drug treatments Renal failure Renal Insufficiency - complications Young Adult Zanamivir Zanamivir - administration & dosage Zanamivir - adverse effects Zanamivir - pharmacokinetics |
| Title | Pharmacokinetics of Zanamivir following Intravenous Administration to Subjects with and without Renal Impairment |
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