Aristada Initio®
(aripiprazole lauroxil) extended-release injectable suspension
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Disease States
- ARISTADA INITIO, in combination with oral aripiprazole, is indicated for the initiation of ARISTADA when used for the treatment of schizophrenia in adults
- ARISTADA INITIO is only to be used as a single dose to initiate ARISTADA treatment or as a single dose to re-initiate ARISTADA treatment following a missed dose of ARISTADA. ARISTADA INITIO is not for repeated dosing. ARISTADA INITIO is not interchangeable with ARISTADA due to differing pharmacokinetic profiles [see Warnings and Precautions 2].
Initiation Regimen
Initiation Regimen Required for Schizophrenia
Yes2
Oral Supplementation Required During Initiation for Schizophrenia
Yes2
Initiation Regimen for Schizophrenia
675 mg IM ARISTADA INITIO
+
441 mg, 662 mg, 882 mg, or 1064 mg IM ARISTADA (on same day or up to 10 days thereafter)
+
30 mg PO aripiprazole x 12
Disease States
- ARISTADA INITIO, in combination with oral aripiprazole, is indicated for the initiation of ARISTADA when used for the treatment of schizophrenia in adults
- ARISTADA INITIO is only to be used as a single dose to initiate ARISTADA treatment or as a single dose to re-initiate ARISTADA treatment following a missed dose of ARISTADA. ARISTADA INITIO is not for repeated dosing. ARISTADA INITIO is not interchangeable with ARISTADA due to differing pharmacokinetic profiles [see Warnings and Precautions 2].
Reconstitution
Reconstitution Required
No2
How Supplied
Aqueous suspension2
Preparation Instructions
Tap the syringe containing ARISTADA INITIO at least 10 times and then shake vigorously for a minimum of 30 seconds.2
Requirements Once Prepared or Reconstituted
If not administered within 15 mins of preparation, then shake again for 30 seconds.2
Dosing Strengths
Number of Dosing Options Available
12
Preparation Kits Available
- Single-dose, prefilled syringe kit (675 mg)2
Dose Strengths
- 675 mg (equivalent to 459 mg aripiprazole)2
Equivalencies
675 mg dose contains 459 mg aripiprazole2
Maintenance Dose for Schizophrenia
(Only to be used as a one-time, single dose to initiate ARISTADA treatment or as a single dose to reinitiate ARISTADA treatment following a missed dose of ARISTADA.)2
Dosing Frequency
ARISTADA INITIO is not for repeat dosing.2 ARISTADA INITIO is not interchangeable with ARISTADA due to differing pharmacokinetic profiles [see Warnings and Precautions 2].
Injection Volumes
- 2.4 mL (675 mg dose)2
Needle Size
Needle Lengths
1, 1.5, 22
Needle Gauges
20, 212
Injection Route
Injection Site(s)
IM (deltoid or gluteal)2
Deltoid Administration (Needle Gauge & Length)
21 gauge, 1-inch
20 gauge, 1.5-inch2
Gluteal Administration (Needle Gauge & Length)
20 gauge, 1.5-inch
20 gauge, 2-inch2
Subcutaneous Administration (Needle Gauge & Length)
n/a
How Supplied
How Supplied
Aqueous suspension2
Preparation Kits Available
- Single-dose, prefilled syringe kit (675 mg)2
Kit Contents
1 single-dose, prefilled syringe containing ARISTADA INITIO aqueous suspension
+
3 safety needles to choose from for drug administration2
Storage
Kit Storage (Refrigeration Required)
No2
Kit Storage (Specific Temperature Requirements)
Store prefilled syringe kit at room temperature (68°F to 77°F; 20°C to 25°C).2
Do not freeze.2
Kit Storage (Excursions Permitted)
Excursions permitted between 59°F and 86°F (15°C and 30°C).2
Kit Storage (Protect from Light)
Not stated in PI
Kit Storage (Other Requirements)
Not stated in PI
Temperature Requirements for Drug Preparation
Room Temperature2
Preparation Instructions
Tap the syringe containing ARISTADA INITIO at least 10 times and then shake vigorously for a minimum of 30 seconds.2
Requirements Once Prepared or Reconstituted
If not administered within 15 mins of preparation, then shake again for 30 seconds.2
tv46-US-NP-00158 November 2024
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