Abilify Asimtufii^®

• Schizophrenia in adults ¹⁴
• Bipolar I disorder in adults ¹⁴

Initiation Regimen Required for Schizophrenia

Yes¹⁴

Oral Supplementation Required During Initiation for Schizophrenia

Yes¹⁴

Initiation Regimen for Schizophrenia

960 mg IM once every 2 months (56 days after previous injection + 10 mg to 20 mg PO aripiprazole* x 14 days

*For patients receiving oral aripiprazole, administer the first dose of ABILIFY ASIMTUFII along with oral aripiprazole for 14 days. For patients already stable on another oral antipsychotic (and known to tolerate aripiprazole), administer the first dose of ABILIFY ASTIMTUFII injection along with the oral antipsychotic for 14 days.¹⁴

Disease States

• Schizophrenia in adults ¹⁴
• Bipolar I disorder in adults ¹⁴

Reconstitution Required

No¹⁴

How Supplied

Aqueous suspension¹⁴

Preparation Instructions

Tap the syringe on your hand at least 10 times and then shake vigorously for at least 10 seconds until the medication is uniform.¹⁴

Requirements Once Prepared or Reconstituted

None stated in PI.¹⁴

Number of Dosing Options Available

2¹⁴

Preparation Kits Available

• Single-dose, pre-filled syringe kit (720 mg or 960 mg)¹⁴

Dose Strengths

• 720 mg¹⁴
• 960 mg¹⁴

Equivalencies

Not stated in PI

Maintenance Dose for Schizophrenia

960 mg* Q2M
(≥56 days between doses)¹⁴
*If there are adverse reactions with the 960-mg dose, may consider reducing the dose to 720 mg Q2M¹⁴

Q2M¹⁴

2.4 mL (720 mg dose) - 3.2 mL (960 mg dose)¹⁴

• 2.4 mL (720 mg dose)
• 3.2 mL (960 mg dose)¹⁴

Needle Lengths

1.5, 2¹⁴

Needle Gauges

21, 22¹⁴

Injection Site(s)

IM (gluteal only)¹⁴

Deltoid Administration (Needle Gauge & Length)

n/a

Gluteal Administration (Needle Gauge & Length)

22-gauge / 1.5-inch (non-obese patients)¹⁴
21-gauge/2-inch (obese patients)¹⁴

Subcutaneous Administration (Needle Gauge & Length)

n/a

How Supplied

Aqueous suspension¹⁴

Preparation Kits Available

Single-dose, pre-filled syringe kit (720 mg or 960 mg) ¹⁴

Kit Contents

1 single-dose, pre-filled syringe containing ABILIFY ASIMTUFII aqueous suspension + 2 safety needles to choose from for drug administration¹⁴

Kit Storage (Refrigeration Required)

No¹⁴

Kit Storage (Specific Temperature Requirements)

Store at 77F (25C) ¹⁴

Kit Storage (Excursions Permitted)

Excursions permitted between 59°F and 86°F (15°C and 30°C) ¹⁴

Kit Storage (Protect from Light)

Not stated in PI ¹⁴

Kit Storage (Other Requirements)

No ¹⁴

Temperature Requirements for Drug Preparation

n/a

Preparation Instructions

Tap the syringe on your hand at least 10 times and then shake vigorously for at least 10 seconds until the medication is uniform ¹⁴

Requirements Once Prepared or Reconstituted

n/a