What is Abilify Asimtufii?
Abilify Asimtufii is a long-acting injectable formulation of aripiprazole monohydrate administered intramuscularly in the gluteal muscle once every 2 months for the treatment of schizophrenia in adults and as maintenance monotherapy for bipolar I disorder in adults. 1
Formulation and Administration
Abilify Asimtufii is a ready-to-use, pre-filled syringe containing aripiprazole monohydrate as a white to off-white sterile aqueous extended-release suspension. It is available in two dose strengths:
- 720 mg (equivalent to AOM 300 mg monthly)
- 960 mg (equivalent to AOM 400 mg monthly)
The injection must be administered by a healthcare provider in the gluteal muscle only (not deltoid) once every 2 months (56 ± 2 days). 1, 2
Initiation Options
There are two pathways to start Abilify Asimtufii if you are currently on oral antipsychotics 1:
1-Day Initiation:
- Give 1 injection of Abilify Asimtufii in the buttock
- Give 1 injection of Abilify Maintena in the arm or opposite buttock on the same day
- Give 1 dose of oral aripiprazole on the same day
14-Day Initiation:
- Give 1 injection of Abilify Asimtufii in the buttock
- Continue oral aripiprazole or current oral antipsychotic for 14 consecutive days
If the patient is already on Abilify Maintena: Simply substitute the next scheduled Abilify Maintena dose with Abilify Asimtufii and continue every 2 months thereafter. 1
Pharmacokinetics
Following four administrations, Abilify Asimtufii 960 mg delivers a mean steady-state aripiprazole plasma concentration (Cavg,ss) of 263 ng/mL over the 2-month dosing interval, with a mean Cmax of 342 ng/mL during the fourth dosing interval. These concentrations remain well above the minimum therapeutic concentration of 95 ng/mL throughout the entire 2-month period. 3, 4
The aripiprazole exposure from Abilify Asimtufii 960 mg every 2 months is equivalent to Abilify Maintena 400 mg monthly, with a geometric mean ratio of 1.006 (90% CI 0.851-1.190). 3
Safety Profile
The most common adverse events include 1, 3:
- Weight increase (22.7%)
- Injection-site pain (18.2%)
- Akathisia
- Sedation
Critical warnings include increased risk of death in elderly patients with dementia-related psychosis (black box warning), neuroleptic malignant syndrome, tardive dyskinesia, metabolic changes (hyperglycemia, diabetes, dyslipidemia), and cerebrovascular events. 1
Dosing Window and Missed Doses
The injection can be given within ± 2 weeks of the scheduled date. If ≥14 weeks have passed since the prior injection, reinitiation is necessary. 1, 2
Clinical Context
Long-acting injectable antipsychotics like Abilify Asimtufii address the critical issue of medication non-adherence in schizophrenia and bipolar disorder, which is a major modifiable risk factor for relapse. 5, 6 The 2-month formulation extends the dosing interval compared to monthly LAIs, potentially improving convenience and adherence while maintaining therapeutic aripiprazole concentrations. 2, 3