ARISTADA

ARISTADA- aripiprazole lauroxil injection, suspension, extended release
Alkermes, Inc.

1 INDICATIONS AND USAGE

ARISTADA is indicated for the treatment of schizophrenia in adults [see Clinical Studies (14)].

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

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.

There are two ways to initiate treatment with ARISTADA:

• Option #1: Administer one intramuscular injection of ARISTADA INITIO 675 mg (in either the deltoid or gluteal muscle) and one dose of oral aripiprazole 30 mg in conjunction with the first ARISTADA injection.
  • The first ARISTADA injection may be administered on the same day as ARISTADA INITIO or up to 10 days thereafter. See the ARISTADA INITIO prescribing information for additional information regarding administration of ARISTADA INITIO.
  • Avoid injecting both ARISTADA INITIO and ARISTADA concomitantly into the same deltoid or gluteal muscle.
• Option #2: Administer 21 consecutive days of oral aripiprazole in conjunction with the first ARISTADA injection.

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, 882 mg administered every 6 weeks or 1064 mg administered every 2 months. The 441 mg, 662 mg, 882 mg and 1064 mg doses correspond to 300 mg, 450 mg, 600 mg and 724 mg of aripiprazole, respectively [see Clinical Pharmacology (12.3)].

Table 1: ARISTADA Dosing Frequency and Site of Injection

Dose	Dosing Frequency	Site of Intramuscular Injection
441 mg	Monthly	Deltoid or Gluteal
662 mg	Monthly	Gluteal
882 mg	Monthly or every 6 weeks	Gluteal
1064 mg	Every 2 months	Gluteal

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

Table 2: ARISTADA Doses Based on Oral Aripiprazole Total Daily Dose

Oral Aripiprazole Dose	Intramuscular ARISTADA Dose
10 mg per day	441 mg every month
15 mg per day	662 mg every month882 mg every 6 weeks1064 mg every 2 months
20 mg or higher per day	882 mg every month

In conjunction with the first ARISTADA injection, administer a single injection of ARISTADA INITIO and one dose of oral aripiprazole 30 mg, or continue treatment with oral aripiprazole for 21 consecutive days [see Recommended Dosage ( 2.1)].

Adjust the ARISTADA dose as needed. When making dose and dosing interval adjustments, consider the pharmacokinetics and prolonged-release characteristics of ARISTADA [see Clinical Pharmacology ( 12.3)].

2.2 Missed Doses

When a dose of ARISTADA is missed, administer the next injection of ARISTADA as soon as possible. Depending on the time elapsed since the last ARISTADA injection, supplement the next ARISTADA injection as recommended in Table 3 below.

Table 3: Recommendation for Concomitant Supplementation Following Missed Doses of ARISTADA

Dose of Patient’s Last ARISTADA Injection	Length of Time Since Last Injection
a The patient should supplement with the same dose of oral aripiprazole as when the patient began ARISTADA (see Table 2).
441 mg	≤ 6 weeks	> 6 and ≤ 7 weeks	> 7 weeks
662 mg	≤ 8 weeks	> 8 and ≤ 12 weeks	> 12 weeks
882 mg	≤ 8 weeks	> 8 and ≤ 12 weeks	> 12 weeks
1064 mg	≤ 10 weeks	> 10 and ≤ 12 weeks	> 12 weeks
Dosage and Administration for Re-initiation of ARISTADA	No Supplementation Required	Supplement with a Single Dose of ARISTADA INITIO OR 7 Days of Oral Aripiprazolea	Re-initiate with a Single Dose of ARISTADA INITIO and a Single Dose of Oral Aripiprazole 30 mg OR supplement with 21 Days of Oral Aripiprazolea

2.3 Early Dosing

The recommended ARISTADA dosing interval is monthly for the 441 mg, 662 mg and 882 mg doses, every 6 weeks for the 882 mg dose, or every 2 months for the 1064 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.