What should clinicians know about Abilify Asimtufii (aripiprazole LAI)?

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
For patients receiving Abilify Maintena (once monthly dosing):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.

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

Reconsititution 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

  • 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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