Aripiprazole Lauroxil Extended-Release Injectable (ARISTADA)

Last updated: November 1, 2016 at 2:10 am
By Flavio Guzman, MD

Highlights of prescribing information

• To be administered by intramuscular injection in the deltoid (441 mg dose only) or gluteal (441 mg, 662 mg or 882 mg) muscle by a healthcare professional.
• For patients naïve to aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment with ARISTADA.
• ARISTADA can be initiated at a dose of 441 mg, 662 mg or 882 mg administered monthly or 882 mg dose every 6 weeks.
• In conjunction with the first ARISTADA injection, administer treatment with oral aripiprazole for 21 consecutive days.
• Dosing regimen adjustments may be required for missed doses.
• Dose adjustments are required for:
  • 1) known CYP2D6 poor metabolizers
  • 2) for patients taking CYP3A4 inhibitors, CYP2D6 inhibitors, or CYP3A4 inducers for more than 2 weeks.

Dosage forms and strengths

ARISTADA is a white to off-white aqueous extended-release suspension provided in a single-use pre-filled syringe for intramuscular injection in the deltoid or gluteal muscle at the 441 mg dose strength and in the gluteal muscle at dose strengths of 662 mg and 882 mg.

ARISTADA is available as described in the following table:

Dosage and administration

Schizophrenia treatment

ARISTADA is only to be administered as an intramuscular injection by a healthcare professional. For patients who have never taken aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment with ARISTADA. Due to the half-life of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability. Refer to the prescribing information of oral aripiprazole for the recommended dosage and administration of the oral formulation.
Depending on individual patient’s needs, treatment with ARISTADA can be initiated at a dose of 441 mg, 662 mg or 882 mg administered monthly, which corresponds to 300 mg, 450 mg and 600 mg of aripiprazole, respectively. Treatment may also be initiated with the 882 mg dose every 6 weeks .
Administer ARISTADA either in the deltoid muscle (441 mg dose only) or gluteal muscle (441 mg, 662 mg or 882 mg).

Use the following ARISTADA doses for patients who are stabilized on oral aripiprazole, as shown in Table 2.

In conjunction with the first ARISTADA injection, administer treatment with oral aripiprazole for 21 consecutive days.
Dose may be adjusted as needed. When making dose and dosing interval adjustments, the pharmacokinetics and prolonged-release characteristics of ARISTADA should be considered [see Clinical Pharmacology

Missed Doses

When a dose is missed, administer the next injection of ARISTADA as soon as possible. If the time elapsed since the last ARISTADA injection exceeds the length of time noted in Table 3, use oral aripiprazole supplementation with the next ARISTADA injection as recommended below.

Early Dosing

The recommended ARISTADA dosing interval is either monthly for the 441 mg, 662 mg and 882 mg doses or every 6 weeks for 882 mg dose and should be maintained. In the event of early dosing, an ARISTADA injection should not be given earlier than 14 days after the previous injection.

Dose Adjustments for CYP450 Considerations

Refer to the prescribing information for oral aripiprazole for recommendations regarding dosage adjustments due to drug interactions, for the first 21 days when the patient is taking oral aripiprazole concomitantly with the first dose of ARISTADA.

More information on aripiprazole

• Aripiprazole Indications: FDA-Approved and Off-Label Uses
• Mechanism of Action of Aripiprazole
• Pharmacokinetics of Aripiprazole: Clinical Summary
• Aripiprazole for Schizophrenia
• Aripiprazole for Mania
• Aripiprazole for Depression

References