Drug Detail:Aristada injection (Aripiprazole lauroxil (injection) [ ar-i-pip-ra-zole ])
Generic Name: aripiprazole lauroxil 441mg in 1.6mL
Dosage Form: injection, suspension, extended release
Drug Class: Atypical antipsychotics
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)].
| 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.
| Oral Aripiprazole Dose | Intramuscular ARISTADA Dose |
|---|---|
| 10 mg per day | 441 mg every month |
| 15 mg per day | 662 mg every month 882 mg every 6 weeks 1064 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)].
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.
| 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 |
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.
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).
| Concomitant Medicine | Dose Change for ARISTADAa |
|---|---|
|
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. |
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.
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.
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.
| 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.
4. PRIME the syringe to remove air.
4a. Bring the syringe into upright position and tap the syringe to bring air to the top.
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.
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.
6. DISPOSE of the needle. Cover the needle by pressing the safety device. Dispose of used and unused items in a proper waste container.
