What is the dosing regimen for aripiprazole injectable (Abilify Injectable), including the acute agitation formulation (Abilify Rapid) and the monthly maintenance formulation (Abilify Maintena)?

Dosing Patterns for Abilify Injectable

Abilify Rapid (Intramuscular Aripiprazole for Acute Agitation)

For acute agitation in schizophrenia or bipolar I disorder, administer aripiprazole 9.75 mg intramuscularly, with a recommended dose range of 5.25–15 mg per injection. 1

Standard Dosing Protocol

• The recommended starting dose is 9.75 mg IM for most adults with acute agitation associated with schizophrenia or bipolar I disorder. 12
• The dose may be repeated after 2 hours or longer if clinically indicated, with a maximum cumulative daily dose of 29.25 mg (three 9.75 mg injections). 1
• Clinical response typically begins within 30 minutes, with progressive improvement in agitation scores through 90–120 minutes. 3

Population-Specific Adjustments

• Elderly or debilitated patients: Start with 5.25 mg IM, as this population requires dose reduction due to increased sensitivity to sedative effects. 1
• Patients on CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine): Reduce dose to 5.25 mg IM due to decreased aripiprazole clearance. 1
• Patients on CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): Reduce dose to 5.25 mg IM to avoid excessive drug accumulation. 1
• Patients on CYP3A4 inducers (e.g., carbamazepine, rifampin): May require dose increase, though specific IM dosing guidance is limited; monitor clinical response closely. 1

Administration Guidelines

• Inject into the deltoid or gluteal muscle using proper IM technique. 1
• Do not administer intravenously or subcutaneously. 1
• If transitioning from IM to oral aripiprazole, initiate oral dosing in place of the next scheduled injection. 1

Safety Monitoring

• Monitor for orthostatic hypotension within the first hour post-injection, particularly in elderly patients. 14
• Assess for extrapyramidal symptoms (EPS), though aripiprazole carries lower EPS risk than haloperidol. 12
• Check vital signs before and after administration, especially blood pressure. 4

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Abilify Maintena (Monthly Long-Acting Injectable)

For maintenance treatment of schizophrenia or bipolar I disorder, administer aripiprazole monohydrate 400 mg IM once monthly after achieving oral stabilization. 56

Initiation and Stabilization

• Establish tolerability with oral aripiprazole (10–30 mg daily) for at least 2 weeks before initiating the LAI formulation. 5
• Continue oral aripiprazole 10–20 mg daily for 14 consecutive days after the first Abilify Maintena injection to ensure therapeutic plasma levels. 56

Standard Monthly Dosing

• The recommended dose is 400 mg IM once monthly (every 4 weeks). 56
• A 300 mg IM monthly dose is available for patients who experience dose-related adverse effects or require lower maintenance dosing. 6
• Administer into the deltoid or gluteal muscle; deltoid injections may be preferred for ensuring adherence. 5

Dosing Flexibility

• Injections may be given up to 7 days before or after the scheduled monthly date without compromising efficacy. 5
• If more than 6 weeks have elapsed since the last injection, restart with oral aripiprazole coverage for 14 days. 5

Population-Specific Adjustments

• CYP2D6 poor metabolizers or patients on strong CYP2D6 inhibitors: Reduce dose to 300 mg monthly. 5
• Patients on strong CYP3A4 inhibitors: Reduce dose to 300 mg monthly. 5
• Patients on strong CYP3A4 inducers: Increase dose to 400 mg monthly or consider avoiding the combination due to reduced efficacy. 5

Reconstitution and Storage

• Abilify Maintena is supplied as a lyophilized powder requiring reconstitution with sterile water immediately before injection. 5
• The reconstituted suspension must be used within 2 hours and does not require refrigeration prior to reconstitution. 5

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Abilify Asimtufii (Every-2-Months Long-Acting Injectable)

For maintenance treatment of schizophrenia or bipolar I disorder in stabilized adults, administer aripiprazole monohydrate 960 mg IM every 2 months (or 720 mg IM every 2 months for dose-reduced patients). 6

Initiation Protocol

• Patients must be stabilized on oral aripiprazole or Abilify Maintena 400 mg monthly before transitioning to the 2-month formulation. 6
• When switching from Abilify Maintena 400 mg monthly, administer Abilify Asimtufii 960 mg in place of the next scheduled monthly injection. 6
• When switching from Abilify Maintena 300 mg monthly, administer Abilify Asimtufii 720 mg in place of the next scheduled monthly injection. 6

Standard Every-2-Months Dosing

• The recommended dose is 960 mg IM every 8 weeks for most patients. 6
• A 720 mg IM every 8 weeks dose is available for patients requiring dose reduction. 6
• Administer into the gluteal muscle only; deltoid administration is not approved for this formulation. 6

Dosing Flexibility

• Injections may be given within ± 2 weeks of the scheduled 8-week date (i.e., between weeks 6 and 10). 6
• If 14 weeks or more have elapsed since the last injection, restart with oral aripiprazole coverage for 14 days. 6

Formulation Advantages

• Supplied as a ready-to-use prefilled syringe, eliminating reconstitution steps. 6
• Does not require refrigeration for storage. 6
• Extends dosing interval to every 2 months, reducing injection frequency compared to monthly formulations. 6

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Common Pitfalls to Avoid

• Do not use IM aripiprazole for acute agitation as first-line when benzodiazepines or haloperidol are more appropriate for undifferentiated agitation. 4
• Never administer Abilify Maintena or Asimtufii without prior oral stabilization, as this increases risk of poor tolerability and treatment failure. 5
• Do not confuse the three formulations: Abilify Rapid (9.75 mg for acute agitation), Abilify Maintena (400 mg monthly), and Abilify Asimtufii (960 mg every 2 months) have distinct indications and dosing schedules. 156
• Avoid missing the 14-day oral overlap after the first LAI injection, as plasma levels remain subtherapeutic during this period. 56
• Do not reinitiate LAI therapy without oral coverage if more than 6 weeks (Maintena) or 14 weeks (Asimtufii) have passed since the last injection. 56