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

Abilify Asimtufii

Indication(s)

Schizophrenia, Bipolar I maintenance 

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.

For patients currently receiving an oral antipsychotic, there are two ways to initiate treatment with Abilify Asimtufii:

1-day initiation: Administer one injection of Abilify Asimtufii 960 mg, one injection of Abilify Maintena 400 mg and a single dose of aripiprazole 20 mg

14-day initiation: In conjunction with the first Abilify Asimtufii 960 mg dose, take 14 consecutive days of concurrent oral aripiprazole (10 or 20 mg) or current oral antipsychotic

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

If utilizing the 14-day initiation method: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. Other initiation methods do not require oral overlap.See recommended starting and maintenance dose.

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 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 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.