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.
Abilify Asimtufii | |
Indication(s) | Schizophrenia, Bipolar I maintanance |
Dosing available as prefilled syringes | 720 mg (2.4 mL) 960 mg (3.2 mL) |
Recommended starting and maintenance dose | For patients receiving oral antipsychotics:Starting and maintenance dose is 960 mg (or lower dose of 720 mg for patients who have had adverse reactions) administered every two months |
Drug Metabolizing Enzymes | CYP2D6, CYP3A4 |
Dosing exclusions | 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. |
Loading dose | Not established |
Oral overlap | 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. |
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 aripipra-zole. |
Storage | Room temperature |
Reconstitution or mixing | Tap the syringe on your hand at least 10 times. After tapping, shake the syringe vigorously for at least 10 seconds, until the medication is uniform. Priming of syringe is recommended. |
Injection site | Intramuscular gluteal injection only |
Injection interval | Every 8 weeks |
Preparation | Tap the syringe on your hand at least 10 times. After tapping, shake the syringe vigorously for at least 10 seconds, until the medication is uniform. Priming of syringe is recommended. |
Administration considerations | 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. |
When a dose 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. |
REMS | No |
Additional information | 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 | |
Oral Dose | Abilify Asimtufii Dosage Every 2 Months |
15 mg daily of aripiprazole | 720 mg |
20 mg daily of aripiprazole | 960 mg |
Reference: Otsuka Pharmaceutical Co., LTD. (2023). Abilify Asimtufii prescribing information. |
FDA medication label
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