Abilify Maintena Dosage/Direction for Use

Dosage Overview for the Treatment of Schizophrenia and Maintenance Monotherapy of Bipolar I Disorder: ABILIFY MAINTENA is only to be administered by intramuscular injection by a healthcare professional. The recommended starting and maintenance dose of 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 ABILIFY MAINTENA. Due to the half-life of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability.
After the first ABILIFY MAINTENA injection, administer oral aripiprazole (10 mg to 20 mg) for 14 consecutive days to achieve therapeutic aripiprazole concentrations during initiation of therapy. For patients already stable on another oral antipsychotic (and known to tolerate aripiprazole), after the first ABILIFY MAINTENA injection, continue treatment with the antipsychotic for 14 consecutive days to maintain therapeutic antipsychotic concentrations during initiation of therapy.
If there are adverse reactions with the 400 mg dosage, consider reducing the dosage to 300 mg once monthly.
Dosage Adjustments for Missed Doses: If the second or third doses are missed: If more than 4 weeks and less than 5 weeks have elapsed since the last injection, administer the injection as soon as possible.
If more than 5 weeks have elapsed since the last injection, restart concomitant oral aripiprazole for 14 days with the next administered injection.
If the fourth or subsequent doses are missed: If more than 4 weeks and less than 6 weeks have elapsed since the last injection, administer the injection as soon as possible.
If more than 6 weeks have elapsed since the last injection, restart concomitant oral aripiprazole for 14 days with the next administered injection.
Dosage Adjustments for Cytochrome P450 Considerations: Dosage adjustments to 300mg are recommended in patients who are CYP2D6 poor metabolizers, and in patients taking 400 mg strength syringes with strong CYP2D6 or CYP3A4 inhibitors for greater than 14 days (see Table 2).
Avoid the concomitant use of strong CYP3A4 inhibitors or CYP2D6 inhibitors in patients taking 300mg strength syringes for greater than 14 days due to high aripiprazole concentrations. (See Table 2).
If the CYP3A4 inhibitor or CYP2D6 inhibitor is withdrawn, the ABILIFY MAINTENA dosage may need to be increased (see Dosage Overview for the Treatment of Schizophrenia and Maintenance Monotherapy of Bipolar I Disorder as previously mentioned).
Avoid the concomitant use of CYP3A4 inducers with ABILIFY MAINTENA for greater than 14 days because the blood levels of aripiprazole are decreased and may be below the effective levels.
Dosage adjustments are not recommended for patients with concomitant use of CYP3A4 inhibitors, CYP2D6 inhibitors or CYP3A4 inducers for less than 14 days. (See Table 2.)

Click on icon to see table/diagram/image

Formulations: ABILIFY MAINTENA is a long-acting aripiprazole formulation with 4 week dosing intervals indicated for the treatment of schizophrenia and maintenance monotherapy of bipolar I disorder in adults.