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Aristada Dosage

Generic name: aripiprazole lauroxil 441mg in 1.6mL
Dosage form: injection, suspension, extended release

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Treatment of Schizophrenia

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 [see Clinical Pharmacology (12.3)].

Administer ARISTADA either in the deltoid muscle (441 mg dose only) or gluteal muscle (441 mg, 662 mg or 882 mg).

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

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 per month
15 mg per day 662 mg per month
20 mg or higher per day 882 mg per month

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 (12.3)].

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.

Table 3: Recommendation for Concomitant Oral Aripiprazole Supplementation Following Missed Dosesa
Dose of Patient's Last ARISTADA Injection Length of Time Since Last Injection
No Oral Supplementation Required Supplement with 7 Days Oral Aripiprazole Supplement with 21 Days Oral Aripiprazole

a The patient should supplement with the same dose of oral aripiprazole as when the patient began ARISTADA (see Table 2).

Monthly 441 mg ≤ 6 weeks > 6 and ≤ 7 weeks > 7 weeks
Monthly 662 mg ≤ 8 weeks > 8 and ≤ 12 weeks > 12 weeks
Monthly 882 mg ≤ 8 weeks > 8 and ≤ 12 weeks > 12 weeks
882 mg every 6 weeks ≤ 8 weeks > 8 and ≤ 12 weeks > 12 weeks

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.

Once stabilized on ARISTADA, refer to the dosing recommendations below for patients taking CYP2D6 inhibitors, CYP3A4 inhibitors, or CYP3A4 inducers:

  • No dosage changes recommended for ARISTADA, if CYP450 modulators are added for less than 2 weeks.
  • Make dose changes to ARISTADA if CYP450 modulators are added for greater than 2 weeks (see Table 4).
Table 4: ARISTADA Dose Adjustments with Concomitant CYP450 Modulator Use
Concomitant Medicine Dose Change for ARISTADAa

a For the 882 mg dose administered every 6 weeks, the next lower strength should be 441 mg administered every 4 weeks.

Strong CYP3A4 Inhibitor Reduce the dose of ARISTADA to the next lower strength. No dosage adjustment is necessary in patients taking 441 mg ARISTADA, if tolerated.
For patients known to be poor metabolizers of CYP2D6: Reduce dose to 441 mg from 662 mg or 882 mg. No dosage adjustment is necessary in patients taking 441 mg ARISTADA, if tolerated.
Strong CYP2D6 Inhibitor Reduce the dose of ARISTADA to the next lower strength. No dosage adjustment is necessary in patients taking 441 mg ARISTADA, if tolerated.
For patients known to be poor metabolizers of CYP2D6: No dose adjustment required.
Both Strong CYP3A4 Inhibitor and Strong CYP2D6 Inhibitor Avoid use for patients at 662 mg or 882 mg dose. No dosage adjustment is necessary in patients taking 441 mg ARISTADA, if tolerated.
CYP3A4 Inducers No dose adjustment for 662 mg and 882 mg dose, increase the 441 mg dose to 662 mg.

Instructions for Use

The kit contains a syringe containing ARISTADA sterile aqueous suspension and 2 or 3 safety needles depending on dose (a 2-inch 20 gauge needle with yellow needle hub, a 1 ½-inch 20 gauge needle with yellow needle hub, and a 1-inch 21 gauge needle with green needle hub (441 mg kit only)) for intramuscular injection. All materials should be stored at room temperature.

Figure
Figure

A | 5 ML SYRINGE containing ARISTADA sterile aqueous suspension

B | 20 GAUGE NEEDLE, 2-INCH with yellow needle hub

C | 20 GAUGE NEEDLE, 1½-INCH with yellow needle hub

D | 21 GAUGE NEEDLE, 1-INCH with green needle hub

1. TAP and SHAKE the syringe.

Figure

1a. Tap the syringe at least 10 times to dislodge any material which may have settled.

1b. Shake the syringe vigorously for a minimum of 30 seconds to ensure a uniform suspension. If the syringe is not used within 15 minutes, shake again for 30 seconds.

2. SELECT the injection needle.

2a. Select injection site.

2b. Select needle length based on injection site. For patients with a larger amount of subcutaneous tissue overlaying the injection site muscle, use the longer of the needles provided.

Table 5: Injection Site and Associated Needle Length
INJECTION SITE NEEDLE LENGTH
441 mg dose
Deltoid 21 GAUGE, 1-INCH or 20 GAUGE, 1½-INCH
Gluteal 20 GAUGE, 1½-INCH or 20 GAUGE, 2-INCH
662 mg dose
Gluteal 20 GAUGE, 1½-INCH or 20 GAUGE, 2-INCH
882 mg dose
Gluteal 20 GAUGE, 1½-INCH or 20 GAUGE, 2-INCH

3. ATTACH the injection needle.

Attach the appropriate needle securely with a clockwise twisting motion. Do NOT overtighten. Overtightening could lead to needle hub cracking.

Figure

4. PRIME the syringe to remove air.

4a. Bring the syringe into upright position and tap the syringe to bring air to the top.

Figure

4b. Remove air by depressing the plunger rod. A few drops of suspension will be released.

Figure

5. ADMINISTER the entire content intramuscularly. Do not inject by any other route. Inject in a rapid and continuous manner (less than 10 seconds).

Figure

6. DISPOSE of the needle. Cover the needle by pressing the safety device. Dispose of used and unused items in a proper waste container.

Figure
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