Abilify Maintena Dosage/Direction for Use

Dosage Overview for the Treatment of Schizophrenia and Maintenance Monotherapy of Bipolar I Disorder: Aripiprazole (Abilify Maintena) is only to be administered by intramuscular injection by a healthcare professional. The recommended starting and maintenance dose of Aripiprazole (Abilify Maintena) is 400 mg monthly (no sooner than 26 days after the previous injection).
For patients who have never taken aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment with Aripiprazole (Abilify Maintena). Due to the half-life of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability.
Titration of the dose for Aripiprazole (Abilify Maintena) is not required.
The starting dose can be administered by following one of two regimens: One injection start: On the day of initiation, administer one injection of 400 mg Aripiprazole (Abilify Maintena) and continue treatment with 10 mg to 20 mg oral aripiprazole per day for 14 consecutive days to maintain therapeutic aripiprazole concentrations during initiation of therapy.
Two injection start: On the day of initiation, administer two separate injections of 400 mg Aripiprazole (Abilify Maintena) at separate injection sites (see Method of Administration as follows), along with one 20 mg dose of oral aripiprazole.
If there are adverse reactions with the 400 mg dosage, reduction of the dose to 300 mg once monthly should be considered.
Dosage Adjustments for Missed Doses: See Table 2.

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Dosage Adjustments for Cytochrome P450 Considerations: In patients who are known to be CYP2D6 poor metabolisers: One injection start: The starting dose should be 300 mg Aripiprazole (Abilify Maintena) and continue treatment with prescribed dose of oral aripiprazole per day for 14 consecutive days.
Two injection start: The starting dose should be 2 separate injections of 300 mg Aripiprazole (Abilify Maintena) (see Method of Administration under Cutions for Usage) along with one single dose of the previous prescribed dose of oral aripiprazole.
Maintenance dose adjustments due to interactions with CYP2D6 and/or CYP3A4 inhibitors and/or CYP3A4 inducers: Maintenance dosage adjustments should be made in patients taking concomitant strong CYP3A4 inhibitors or strong CYP2D6 inhibitors for more than 14 days. If the CYP3A4 inhibitor or CYP2D6 inhibitor is withdrawn, the dosage may need to be increased to the previous dose. In case of adverse reactions despite dose adjustments of Aripiprazole (Abilify Maintena), the necessity of concomitant use of CYP2D6 or CYP3A4 inhibitor should be reassessed.
Concomitant use of CYP3A4 inducers with Aripiprazole (Abilify Maintena) should be avoided for more than 14 days because the blood levels of aripiprazole are decreased and may be below the effective levels. (See Table 3.)

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