Abilify Asimtufii is a long-acting injectable (LAI) formulation of aripiprazole. It is a two-month preparation using the same technology as the one-month preparation called Abilify Maintena. Abilify Asimtufii is FDA-indicated to treat adults with schizophrenia and as maintenance monotherapy treatment of bipolar I disorder in adults.
Establishing tolerability
- Prior to initiating Abilify Asimtufii, establish tolerability with oral aripiprazole in aripiprazole-naïve patients.
- Due to its long half-life, establishing tolerability may require up to a two-week trial of oral aripiprazole.
Dosing
- Once every 8 weeks intramuscular gluteal injection only, which must be administered by a healthcare provider.
- No loading dose strategy is available. Two weeks of oral overlap of aripiprazole (at therapeutic range of 10-20 mg/day) or another antipsychotic is recommended to continue at the time of first injection, unless the patient is currently receiving Abilify Maintena.
- For patients receiving oral antipsychotics, the recommended starting and maintenance dose is 960 mg (or lower dose of 720 mg for patients who have had adverse reactions) administered every two months.
- For patients receiving Abilify Maintena (once monthly dosing), the recommended starting and maintenance dose is 960 mg (or lower dose of 720 mg for patients who have had adverse reactions) in place of the next scheduled injection of the Abilify Maintena. The first dose of Abilify Asimtufii may be administered in place of the second, or later injection of Abilify Maintena.
- Patients may be given the Abilify Asimtufii injection up to 2 weeks before or 2 weeks after the 2-month scheduled timepoint.
Dose Conversion of Oral Aripiprazole to Abilify Asimtufii |
| Abilify Asimtufii Dosage Every 2 Months |
15 mg daily of aripiprazole | |
20 mg daily of aripiprazole | |
Reference: Otsuka Pharmaceutical Co., LTD. (2023). Abilify Asimtufii prescribing information. |
- Patients who are stable on oral aripiprazole doses lower than 10 mg/day or higher than 20 mg/day may not be candidates for Abilify Asimtufii.
- No loading dose recommended. Fourteen days of oral overlap is required unless switching from Abilify Maintena.
- When a dose of Abilify Asimtufii is missed, if it is more than 8 weeks and less than 14 weeks, administer the next dose as soon as possible. If more than 14 weeks have elapsed, restart concomitant oral aripiprazole for 14 days with the next injection. See this tip for more information.
Practical issues (including administration)
- The syringe needs to be tapped at least 10 times on the hand and shaken vigorously for at least 10 seconds prior to administration.
- All doses should be administered intramuscularly in the gluteal muscle.
FDA medication label
- Information on this topic is found in the FDA medication label.
- Medication labels can be found by searching Drugs@FDA at the FDA website. Labels are also available using the Drugs@FDA app for Apple or Android devices. Labels change over time, and the current label should always be consulted.
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