ARISTADA (Page 2 of 8)

2.4 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 21 days of oral aripiprazole concomitantly with the first dose of ARISTADA. Avoid initiating ARISTADA treatment with ARISTADA INITIO in patients requiring dose adjustments.

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

a For 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.

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, 882 mg, or 1064 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, 882 mg, or 1064 mg dose. No dosage adjustment is necessary in patients taking 441 mg ARISTADA, if tolerated.
CYP3A4 Inducers No dose adjustment for 662 mg, 882 mg, or 1064 mg dose; increase the 441 mg dose to 662 mg.

2.5 Important Administration Instructions

The kit contains a syringe containing ARISTADA sterile aqueous extended-release injectable 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 extended-release injectable 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 vigorously SHAKE the syringe.

Figure
(click image for full-size original)

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
1064 mg dose
Gluteal 20 gauge, 1½-inch or 20 gauge, 2-inch

[see Dosage and Administration ( 2.1)]

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. Depress the plunger rod to remove air until a few drops are released. It is normal to see small air bubbles remaining in the syringe.

Figure

5. Inject in a RAPID and CONTINUOUS manner. Product requires a RAPID injection. Do not hesitate. Administer the entire content intramuscularly. Do not inject by any other route.

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
Figure Figure Figure Figure Figure Figure Figure Figure

3 DOSAGE FORMS AND STRENGTHS

ARISTADA is a white to off-white aqueous extended-release injectable suspension provided in a single-dose pre-filled syringe.

ARISTADA is available as described in Table 6.

Table 6: Presentations of ARISTADA
Dose Strength Volume Inject Intramuscularly Color Label
441 mg 1.6 mL Deltoid or Gluteal Muscle Light Blue
662 mg 2.4 mL Gluteal Muscle Only Green
882 mg 3.2 mL Gluteal Muscle Only Burgundy
1064 mg 3.9 mL Gluteal Muscle Only Dark Blue

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