An alternative start regimen with aripiprazole once-monthly in patients with schizophrenia: population pharmacokinetic analysis of a single-day, two-injection start with gluteal and/or deltoid intramuscular injection

Abstract

Background: The single-injection start regimen for aripiprazole once-monthly 400 mg (AOM 400) in patients with schizophrenia requires a single intramuscular injection in the gluteal or deltoid site and 14 days of concurrent oral therapy. A simplified, single-day regimen of two injections at separate gluteal and/or deltoid injection sites, together with a single 20-mg dose of oral aripiprazole on the 1st day, was assessed. Patients and methods: A previously developed population-pharmacokinetic (popPK) model for characterizing aripiprazole PK following oral administration and gluteal intramuscular depot injection was expanded to include deltoid injection. Simulations were conducted to assess PK profiles following various (including two-injection) start regimens. Postmarketing data on patients who received higherthan-recommended AOM doses were used to assess overall safety/tolerability. Results: The two-injection start regimen with a single concurrent oral dose displayed a comparable PK profile to the single-injection start regimen with concurrent 14-day oral administration in simulations. The safety assessment indicated the two-injection start regimen was unlikely to be associated with safety concerns beyond those expected with a single-injection start regimen. Conclusion: These data support use of the two-injection start regimen in clinical practice to reduce reliance on daily oral administration and optimize the therapeutic benefits of AOM 400 in patients with schizophrenia.

Validation of the Arabic Version of General Medication Adherence Scale (GMAS) in Sudanese Patients with Diabetes Mellitus

“…13,17 Arabic and Chinese versions of the scale have recently been validated in the Saudi and Chinese populations, respectively. 18,19 The highest score that can be achieved is 33. Based upon the score, adherence levels are categorized as high, [27][28][29][30][31] good, [25][26][27] partial, 15-24 low 9-14 and poor (≤10).…”

Clinical Experience on the Use of a Single-day, Two-injection Start Initiation Regimen of Aripiprazole Once Monthly in Patients With Schizophrenia in Spain: SaTISfy Study

“…According to most psychiatrists, AOM400-TIS was administered during hospital admission after symptom stabilization, suggesting a potential benefit of its early use. The AOM400-TIS was proposed based on a simulation pointing to a profile similar to that of the AOM400 1 injection start that involves 1 injection and oral supplementation for 14 days, suggesting similar stable plasma levels of aripiprazole and no incremental safety risk 16 . After the approval of AOM400-TIS, one study analyzed the efficacy and safety of this alternative regimen, obtaining favorable results, but it was a single case study in an adolescent for whom the LAI formulation was off-label 36 .…”

Real-world effectiveness of aripiprazole once-monthly REACT study: Pooled analysis of two noninterventional studies

“…One-hundred and eighty-four patients did not use oral aripiprazole for exactly 2 weeks after starting AOM, as was indicated in the product label when the studies were conducted. An alternative initiation regimen is now available in Europe and Canada which consists of injecting two doses of AOM at two different sites with one oral dose of 20 mg aripiprazole as supplementation, which in simulations displayed a comparable pharmacokinetic profile to the single-injection start regimen with concurrent 14-day oral administration [ 25 ]. The two-injection start regimen is expected to make such dosage excursions less likely.…”