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Aripiprazole Once-Monthly 400 mg: Comparison of Pharmacokinetics, Tolerability, and Safety of Deltoid Versus Gluteal Administration

BACKGROUND: Two open-label, randomized, parallel-arm studies compared pharmacokinetics, safety, and tolerability of aripiprazole once-monthly 400 mg following deltoid vs gluteal injection in patients with schizophrenia. METHODS: In the single-dose study, 1 injection of aripiprazole once-monthly 400...

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Autores principales: Raoufinia, Arash, Peters-Strickland, Timothy, Nylander, Anna-Greta, Baker, Ross A., Eramo, Anna, Jin, Na, Bricmont, Patricia, Repella, Jennifer, McQuade, Robert D., Hertel, Peter, Larsen, Frank
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5409034/
https://www.ncbi.nlm.nih.gov/pubmed/28204607
http://dx.doi.org/10.1093/ijnp/pyw116
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author Raoufinia, Arash
Peters-Strickland, Timothy
Nylander, Anna-Greta
Baker, Ross A.
Eramo, Anna
Jin, Na
Bricmont, Patricia
Repella, Jennifer
McQuade, Robert D.
Hertel, Peter
Larsen, Frank
author_facet Raoufinia, Arash
Peters-Strickland, Timothy
Nylander, Anna-Greta
Baker, Ross A.
Eramo, Anna
Jin, Na
Bricmont, Patricia
Repella, Jennifer
McQuade, Robert D.
Hertel, Peter
Larsen, Frank
author_sort Raoufinia, Arash
collection PubMed
description BACKGROUND: Two open-label, randomized, parallel-arm studies compared pharmacokinetics, safety, and tolerability of aripiprazole once-monthly 400 mg following deltoid vs gluteal injection in patients with schizophrenia. METHODS: In the single-dose study, 1 injection of aripiprazole once-monthly 400 mg in the deltoid (n=17) or gluteal (n=18) muscle (NCT01646827) was administered. In the multiple-dose study, the first aripiprazole once-monthly 400 mg injection was administered in either the deltoid (n=71) or gluteal (n=67) muscle followed by 4 once-monthly deltoid injections (NCT01909466). RESULTS: After single-dose administration, aripiprazole exposure (area under the concentration-time curve) was similar between deltoid and gluteal administrations, whereas median time to maximum plasma concentration was shorter (7.1 [deltoid] vs 24.1 days [gluteal]) and maximum concentration was 31% higher after deltoid administration. In the multiple-dose study, median time to maximum plasma concentration for deltoid administration was shorter (3.95 vs 7.1 days), whereas aripiprazole mean trough concentrations, maximum concentration, and area under the concentration-time curve were comparable between deltoid and gluteal muscles (historical data comparison). Multiple-dose pharmacokinetic results for the major metabolite, dehydro-aripiprazole, followed a similar pattern to that of the parent drug for both deltoid and gluteal injection sites. Safety and tolerability profiles were similar after gluteal or deltoid injections. Based on observed data, minimum aripiprazole concentrations achieved by aripiprazole once-monthly 400 mg are comparable with those of oral aripiprazole 15 to 20 mg/d. CONCLUSIONS: The deltoid muscle is a safe alternative injection site for aripiprazole once-monthly 400 mg in patients with schizophrenia.
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spelling pubmed-54090342017-05-03 Aripiprazole Once-Monthly 400 mg: Comparison of Pharmacokinetics, Tolerability, and Safety of Deltoid Versus Gluteal Administration Raoufinia, Arash Peters-Strickland, Timothy Nylander, Anna-Greta Baker, Ross A. Eramo, Anna Jin, Na Bricmont, Patricia Repella, Jennifer McQuade, Robert D. Hertel, Peter Larsen, Frank Int J Neuropsychopharmacol Regular Research Article BACKGROUND: Two open-label, randomized, parallel-arm studies compared pharmacokinetics, safety, and tolerability of aripiprazole once-monthly 400 mg following deltoid vs gluteal injection in patients with schizophrenia. METHODS: In the single-dose study, 1 injection of aripiprazole once-monthly 400 mg in the deltoid (n=17) or gluteal (n=18) muscle (NCT01646827) was administered. In the multiple-dose study, the first aripiprazole once-monthly 400 mg injection was administered in either the deltoid (n=71) or gluteal (n=67) muscle followed by 4 once-monthly deltoid injections (NCT01909466). RESULTS: After single-dose administration, aripiprazole exposure (area under the concentration-time curve) was similar between deltoid and gluteal administrations, whereas median time to maximum plasma concentration was shorter (7.1 [deltoid] vs 24.1 days [gluteal]) and maximum concentration was 31% higher after deltoid administration. In the multiple-dose study, median time to maximum plasma concentration for deltoid administration was shorter (3.95 vs 7.1 days), whereas aripiprazole mean trough concentrations, maximum concentration, and area under the concentration-time curve were comparable between deltoid and gluteal muscles (historical data comparison). Multiple-dose pharmacokinetic results for the major metabolite, dehydro-aripiprazole, followed a similar pattern to that of the parent drug for both deltoid and gluteal injection sites. Safety and tolerability profiles were similar after gluteal or deltoid injections. Based on observed data, minimum aripiprazole concentrations achieved by aripiprazole once-monthly 400 mg are comparable with those of oral aripiprazole 15 to 20 mg/d. CONCLUSIONS: The deltoid muscle is a safe alternative injection site for aripiprazole once-monthly 400 mg in patients with schizophrenia. Oxford University Press 2017-02-15 /pmc/articles/PMC5409034/ /pubmed/28204607 http://dx.doi.org/10.1093/ijnp/pyw116 Text en © The Author 2017. Published by Oxford University Press on behalf of CINP. http://creativecommons.org/licenses/by-nc/4.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Regular Research Article
Raoufinia, Arash
Peters-Strickland, Timothy
Nylander, Anna-Greta
Baker, Ross A.
Eramo, Anna
Jin, Na
Bricmont, Patricia
Repella, Jennifer
McQuade, Robert D.
Hertel, Peter
Larsen, Frank
Aripiprazole Once-Monthly 400 mg: Comparison of Pharmacokinetics, Tolerability, and Safety of Deltoid Versus Gluteal Administration
title Aripiprazole Once-Monthly 400 mg: Comparison of Pharmacokinetics, Tolerability, and Safety of Deltoid Versus Gluteal Administration
title_full Aripiprazole Once-Monthly 400 mg: Comparison of Pharmacokinetics, Tolerability, and Safety of Deltoid Versus Gluteal Administration
title_fullStr Aripiprazole Once-Monthly 400 mg: Comparison of Pharmacokinetics, Tolerability, and Safety of Deltoid Versus Gluteal Administration
title_full_unstemmed Aripiprazole Once-Monthly 400 mg: Comparison of Pharmacokinetics, Tolerability, and Safety of Deltoid Versus Gluteal Administration
title_short Aripiprazole Once-Monthly 400 mg: Comparison of Pharmacokinetics, Tolerability, and Safety of Deltoid Versus Gluteal Administration
title_sort aripiprazole once-monthly 400 mg: comparison of pharmacokinetics, tolerability, and safety of deltoid versus gluteal administration
topic Regular Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5409034/
https://www.ncbi.nlm.nih.gov/pubmed/28204607
http://dx.doi.org/10.1093/ijnp/pyw116
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