Aripiprazole Once-Monthly 400 mg: Comparison of Pharmacokinetics, Tolerability, and Safety of Deltoid Versus Gluteal Administration
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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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Aripiprazole concentrations achieved by aripiprazole monohydrate 400 mg once monthly are comparable to those with oral aripiprazole 15-20 mg daily.
“Aripiprazole concentrations achieved by aripiprazole monohydrate 400 mg once monthly are comparable to those with oral aripiprazole 15–20 mg daily [62].”
From Pharmacokinetic Characteristics of Long-Acting Injectable Antipsychotics for Schizophrenia: An Overview (2021) · cites this paper as [62]
The Introduction and Discussion say that trough concentrations with once-monthly 400 mg are similar to those with oral aripiprazole 15–20 mg daily. They compare peak concentrations instead with oral doses of 20–30 mg daily, so the unqualified claim about concentrations is broader than the comparison reported. (LLM, conf=0.83)
Experimental — accuracy not yet measuredAripiprazole monohydrate is administered via intramuscular injection in either the deltoid or the gluteal regions.
“Aripiprazole monohydrate is administered via intramuscular injection in either the deltoid or the gluteal regions [61, 62].”
From Pharmacokinetic Characteristics of Long-Acting Injectable Antipsychotics for Schizophrenia: An Overview (2021) · cites this paper as [62]
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- Authors
- Raoufinia, A., Peters-Strickland, T., Nylander, A.-G., Baker, R. A., Eramo, A., Jin, N., Bricmont, P., Repella, J., McQuade, R. D., Hertel, P., & Larsen, F.
- Affiliations
- Lundbeck (Denmark) (DK)
- Corresponding author
- Raoufinia, Arash
- Venue
- International Journal of Neuropsychopharmacology
- Publisher
- Oxford University Press (OUP)
- Published
- 2017-02-15
- Volume
- 20
- Issue
- 4
- Pages
- 295-304
- ISSN
- 1461-1457 (ISSN-L)
- 1469-5111
- PMC
- PMC5409034
- OpenAlex
- W2607811830
- Cited by
- 39
- References
- 24
- Citations by year
- 2026: 2 · 2025: 5 · 2024: 3 · 2023: 9 · 2022: 4 · 2021: 5 · 2020: 4 · 2018: 6 · 2017: 1
- FWCI
- 2.47
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by-nc
- Locations
- The International Journal of Neuropsychopharmacology (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Health Sciences › Medicine › Emergency Medicine › Intramuscular injections and effects
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmacogenetics and Drug Metabolism
- Keywords
- aripiprazole once-monthly, long-acting injectable antipsychotics, deltoid injection, gluteal injection, injection site comparison, pharmacokinetics, schizophrenia, tolerability, safety, plasma concentration
- MeSH terms
- Aripiprazole, Adolescent, Adult, Analysis of Variance, Buttocks, Dose-Response Relationship, Drug, Female, Follow-Up Studies, Humans, Injections, Intramuscular, Male, Middle Aged, Schizophrenia, Shoulder, Antipsychotic Agents, Area Under Curve, Young Adult
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