Aristada^®

• Schizophrenia in adults³

Initiation Regimen Required for Schizophrenia

Yes³

Oral Supplementation Required During Initiation for Schizophrenia

Yes³

Initiation Regimen for Schizophrenia

There are two ways to initiate treatment with ARISTADA:

Option #1: One dose 675 mg IM ARISTADA INITIO + one dose 30 mg PO aripiprazole in conjunction with the first ARISTADA injection (441 mg, 662 mg, or 882 mg Q1M, 882 mg Q6W, or 1064 mg Q2M). The first ARISTADA injection may be administered on the same day as ARISTADA INITIO or up to 10 days thereafter.

Option #2: PO aripiprazole x 21 days in conjunction with the first ARISTADA injection (441 mg, 662 mg, or 882 mg Q1M, 882 mg Q6W, or 1064 mg Q2M).

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.

Disease States

• Schizophrenia in adults³

Reconstitution Required

No³

How Supplied

Aqueous suspension³

Preparation Instructions

Tap the syringe containing ARISTADA at least 10 times and then shake vigorously for a minimum of 30 seconds.³

Requirements Once Prepared or Reconstituted

If not administered within 15 mins of preparation, then shake again for 30 seconds.³

Number of Dosing Options Available

4³

Preparation Kits Available

• Single-dose, prefilled syringe kit (441 mg, 662 mg, 882 mg, or 1064 mg)³

Dose Strengths

• 441 mg (equivalent to 300 mg aripiprazole)
• 662 mg (equivalent to 450 mg aripiprazole)
• 882 mg (equivalent to 600 mg aripiprazole)
• 1064 mg (equivalent to 724 mg aripiprazole)³

Equivalencies

• 441 mg dose contains 300 mg aripiprazole
• 662 mg dose contains 450 mg aripiprazole
• 882 mg dose contains 600 mg aripiprazole
• 1064 mg dose contains 724 mg aripiprazole
• ≥20 mg QD PO aripiprazole = 882 mg Q1M ARISTADA

------------------------------------------
10 mg QD PO aripiprazole = 441 mg Q1M ARISTADA

15 mg QD PO aripiprazole = 662 mg Q1M, 882 mg Q6WK, or 1064 mg Q2M ARISTADA

≥20 mg QD PO aripiprazole = 882 mg Q1M ARISTADA³

Maintenance Dose for Schizophrenia

• 441 mg Q1M
• 662 mg Q1M
• 882 mg Q1M or Q6WK
• 1064 mg Q2M³

• Q1M (for 441 mg, 662 mg, or 882 mg doses)
• Q6WK (for 882 mg dose)
• Q2M (for 1064 mg dose)³

1.6 mL (441 mg dose) - 3.9 mL (1064 mg dose):³

• 1.6 mL (441 mg dose)
• 2.4 mL (662 mg dose)
• 3.2 mL (882 mg dose)
• 3.9 mL (1064 mg dose)³

Needle Lengths

1, 1.5, 2³

Needle Gauges

20, 21³

Injection Site(s)

IM (deltoid or gluteal)³

Deltoid Administration (Needle Gauge & Length)

21 gauge, 1-inch (441 mg dose)
20 gauge, 1.5-inch (441 mg dose)³

Gluteal Administration (Needle Gauge & Length)

20 gauge, 1.5 inch (441 mg, 662 mg, 882 mg, or 1064 mg dose)
20 gauge, 2-inch (441 mg, 662 mg, 882 mg, or 1064 mg dose)³

Subcutaneous Administration (Needle Gauge & Length)

n/a

How Supplied

Aqueous suspension³

Preparation Kits Available

Single-dose, prefilled syringe kit

• 441 mg
• 662 mg
• 882 mg
• 1064 mg³

Kit Contents

1 single-dose, prefilled syringe containing ARISTADA aqueous suspension
+
2 or 3 safety needles to choose from for drug administration (21G/1-inch [441 mg kit only], 20G/2-inch [all kits], and 20G/1.5-inch [all kits])³

Kit Storage (Refrigeration Required)

No³

Kit Storage (Specific Temperature Requirements)

Store prefilled syringe kit at room temperature (68°F to 77°F; 20°C to 25°C).³

Kit Storage (Excursions Permitted)

Excursions permitted between 59°F and 86°F (15°C and 30°C).³

Kit Storage (Protect from Light)

Not stated in PI

Kit Storage (Other Requirements)

Not stated in PI

Temperature Requirements for Drug Preparation

Room Temperature³

Preparation Instructions

Tap the syringe containing ARISTADA at least 10 times and then shake vigorously for a minimum of 30 seconds.³

Requirements Once Prepared or Reconstituted

If not administered within 15 mins of preparation, then shake again for 30 seconds.³