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ARISTADA CAN BE STARTED AT ANY DOSE

ARISTADA treatment can be initiated with the ARISTADA INITIO regimen*‭

DOSING INTERVALS FOR ARISTADA1

‭*The ARISTADA INITIO regimen is defined as a single injection of ARISTADA INITIO (675 mg) given in conjunction with a single 30 mg dose of oral aripiprazole.2

If not starting ARISTADA with ARISTADA INITIO, administer 21 consecutive days of oral aripiprazole with the first ARISTADA injection.2

  • ARISTADA INITIO™ (aripiprazole lauroxil) is only to be used as a single dose to initiate ARISTADA® (aripiprazole lauroxil) treatment or as a single dose to reinitiate ARISTADA treatment following a missed dose of ARISTADA. ARISTADA INITIO is not for repeated dosing2
  • For patients naïve to aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment with ARISTADA INITIO or ARISTADA1,2
  • ARISTADA INITIO and ARISTADA are not interchangeable because of differing pharmacokinetic profiles2
  • ARISTADA INITIO and ARISTADA are only to be administered as an intramuscular injection by a healthcare professional1,2
  • ARISTADA INITIO can be administered in the deltoid or gluteal muscle.2 ARISTADA can be administered in the gluteal muscle (all doses) or deltoid muscle (441 mg only).1 Avoid injecting both ARISTADA and ARISTADA INITIO concomitantly into the same deltoid or gluteal muscle2
  • Administer one ARISTADA INITIO injection in combination with a single dose of 30 mg oral aripiprazole with the first ARISTADA injection2

Dose adjustment considerations for ARISTADA INITIO

  • No dose adjustments of ARISTADA INITIO can be made2
    • ARISTADA INITIO is only available at a single strength as a single dose pre-filled syringe, so dosage adjustments are not possible. Avoid use in patients who are known CYP2D6 poor metabolizers or taking strong CYP3A4 inhibitors, strong CYP2D6 inhibitors, or strong CYP3A4 inducers, antihypertensive drugs and benzodiazepines2

Dose adjustment considerations for ARISTADA

  • Refer to the oral aripiprazole Prescribing Information 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
  • Once stabilized on ARISTADA, for patients taking CYP2D6 inhibitors, CYP3A4 inhibitors, or CYP3A4 inducers:
    • No dosage changes are recommended for ARISTADA if CYP450 modulators are added for <2 weeks1
    • Dose changes to ARISTADA are required if CYP450 modulators are added for >2 weeks1
  • Depending on the ARISTADA dose, adjustments may be recommended. Refer to the table below

DOSE ADJUSTMENTS WITH CONCOMITANT CYP450 MODULATOR USE1

aFor the 882 mg dose administered every 6 weeks and the 1064 mg administered every 2 months, the next lower strength should be 441 mg administered monthly.

TRANSITIONING PATIENTS ON ORAL ARIPIPRAZOLE TO ARISTADA1

  • In conjunction with the first ARISTADA injection, administer one injection of ARISTADA INITIO and one 30 mg dose of oral aripiprazole or continue treatment with oral aripiprazole for 21 consecutive days1,2

REINITIATING ARISTADA TREATMENT AFTER MISSING A DOSE1,2

DOSE OF LAST ARISTADA INJECTION
LENGTH OF TIME SINCE LAST 1064 MG INJECTION
≤10 weeksNo supplementation required
>10 and ≤12 weeksSupplement with a single dose of ARISTADA INITIOa
>12 weeksReinitiate with a single dose of ARISTADA INITIO and a single dose of 30 mg oral aripiprazoleb
LENGTH OF TIME SINCE LAST 882 MG INJECTION
≤8 weeksNo supplementation required
>8 and ≤12 weeksSupplement with a single dose of ARISTADA INITIOa
>12 weeksReinitiate with a single dose of ARISTADA INITIO and a single dose of 30 mg oral aripiprazoleb
LENGTH OF TIME SINCE LAST 662 MG INJECTION
≤8 weeksNo supplementation required
>8 and ≤12 weeksSupplement with a single dose of ARISTADA INITIOa
>12 weeksReinitiate with a single dose of ARISTADA INITIO and a single dose of 30 mg oral aripiprazoleb
LENGTH OF TIME SINCE LAST 441 MG INJECTION
≤6 weeksNo supplementation required
>6 and
≤7 weeks
Supplement with a single dose of ARISTADA INITIOa
>7 weeksReinitiate with a single dose of ARISTADA INITIO and a single dose of 30 mg oral aripiprazoleb

aAlternatively, if supplementing with oral aripiprazole, the patient should take 7 days of oral aripiprazole at the corresponding dose.1

bAlternatively, if reinitiating with oral aripiprazole, the patient should take 21 days of oral aripiprazole at the corresponding dose.1

  • When any dose is missed, the next injection of ARISTADA needs to be administered as soon as possible1

MODELED PLASMA CONCENTRATIONS FOLLOWING A SINGLE DOSE AT STEADY-STATE3,a,b

aMedian aripiprazole concentrations simulated following the last ARISTADA injection at steady-state.

bSteady-state is achieved 4 months following treatment initiation.

Early dosing guidance

  • The recommended ARISTADA dosing interval of 441 mg, 662 mg, and 882 mg monthly; 882 mg every 6 weeks; or 1064 mg every 2 months should be maintained. In the event of early dosing, an ARISTADA injection should not be given earlier than 14 days after the previous injection1

Review the Important Administration Instructions for ARISTADA INITIO and ARISTADA

Administration Instructions
References: 1. ARISTADA [package insert]. Waltham, MA: Alkermes, Inc; 2018. 2. ARISTADA INITIO [package insert]. Waltham, MA: Alkermes, Inc; 2018. 3. Data on file. Alkermes, Inc.