ARISTADA- aripiprazole lauroxil injection, suspension, extended release
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ARISTADA is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1)].
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)].
|Dose||Dosing Frequency||Site of Intramuscular Injection|
|441 mg||Monthly||Deltoid or 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 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.
|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.
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