Abilify Maintena^®

• Schizophrenia in adults¹
• Bipolar I disorder in adults¹

Initiation Regimen Required for Schizophrenia

Yes¹

Oral Supplementation Required During Initiation for Schizophrenia

Yes¹

Initiation Regimen for Schizophrenia

400 mg IM monthly
+
10 mg to 20 mg PO aripiprazole* x 14 days

*For patients already stable on another oral antipsychotic (and known to tolerate aripiprazole), continue treatment with the current antipsychotic for 14 days after the first ABILIFY MAINTENA injection¹

Disease States

• Schizophrenia in adults¹
• Bipolar I disorder in adults¹

Reconstitution Required

Yes¹

How Supplied

Pre-filled dual chamber syringe

Lyophilized powder for reconstitution¹+
Diluent (Sterile Water for Injection [SWFI])¹

Preparation Instructions

For prefilled dual-chamber syringe kit:

Push, then rotate the plunger to release the diluent (SWFI) from the rear chamber up into the front chamber containing the lyophilized powder. Vertically shake the syringe vigorously for 20 seconds until uniformly milky-white.¹

For vial kit:

Transfer the diluent (SWFI) from its vial into the vial containing the lyophilized powder using aseptic technique and the supplied syringe and pre-attached needle. Shake the vial vigorously for 30 seconds until uniformly milky-white.¹ For the 160-mg dose, use 0.8 mL of SWFI.¹ For the 200-mg dose, use 1 mL of SWFI.¹ For the 300-mg dose, use 1.5 mL of SWFI.¹ For the 400-mg dose, use 1.9 mL of SWFI.¹

Requirements Once Prepared or Reconstituted

Prefilled dual-chamber syringe kit:

Once reconstituted, administer immediately (within 30 minutes after reconstitution).¹

Vial kit:

Once reconstituted, administer immediately.¹If the injection is not performed immediately, keep the vial containing the reconstituted drug at room temperature and then shake the vial vigorously for at least 60 seconds to resuspend the drug prior to injection.¹Do not store the reconstituted suspension in a syringe.¹

Number of Dosing Options Available

4¹

Preparation Kits Available

• Single-dose, prefilled, dual-chamber syringe kit (300 mg or 400 mg)¹
• Single-dose vial kit (300 mg or 400 mg)¹

Dose Strengths

• 160 mg (using vial kit only; inject only 0.8 mL of prepared suspension)¹
• 200 mg (using vial kit only; inject only 1 mL of prepared suspension)¹
• 300 mg¹
• 400 mg¹

Equivalencies

None stated in the PI

Maintenance Dose for Schizophrenia

400 mg* Q1M
(≥26 days between doses)¹

*If there are adverse reactions with the 400-mg dosage, may consider reducing the dosage to 300 mg Q1M¹

Q1M¹

0.8 mL (160 mg dose) - 2 mL (400 mg dose):¹

• 0.8 mL (160 mg dose)¹
• 1 mL (200 mg dose)¹
• 1.5 mL (300 mg dose)¹
• 2 mL (400 mg dose)¹

Needle Lengths

1, 1.5, 2¹

Needle Gauges

21, 22, 23¹

Injection Site(s)

IM (deltoid or gluteal)¹

Deltoid Administration (Needle Gauge & Length)

One 23-gauge, 1-inch (25 mm) hypodermic safety needle with needle protection device for deltoid administration in non-obese patients¹One 22-gauge, 1.5-inch (38 mm) hypodermic safety needle with needle protection device for deltoid administration in obese patients¹

Gluteal Administration (Needle Gauge & Length)

One 22-gauge, 1.5-inch (38 mm) hypodermic safety needle with needle protection device for gluteal administration in non-obese patients¹One 21-gauge, 2-inch (51 mm) hypodermic safety needle with needle protection device for gluteal administration in obese patients¹

Subcutaneous Administration (Needle Gauge & Length)

n/a

How Supplied

Pre-filled dual chamber syringe

Lyophilized powder for reconstitution¹+
Diluent (Sterile Water for Injection [SWFI])¹

Preparation Kits Available

• Single-dose, prefilled, dual-chamber syringe kit (300 mg or 400 mg)¹
• Single-dose vial kit (300 mg or 400 mg)¹

Kit Contents

Single-Dose prefilled Dual-Chamber Syringe Kit

1 single-dose, prefilled, dual-chamber syringe containing lyophilized powder and SWFI¹+
3 safety needles to choose from for drug administration¹

Single-Dose Vial Kit

1 single-dose vial of lyophilized powder + 1 vial of SWFI¹+
1 disposable luer lock syringe with needle pre-attached (for withdrawing SWFI and transferring it into lyophilized powder vial)¹+
1 vial adapter for drawing up the reconstituted suspension from vial¹+
Luer lock syringe with luer lock tip (for administration)¹+
3 safety needles to choose from for drug administration¹

Kit Storage (Refrigeration Required)

No¹

Kit Storage (Specific Temperature Requirements)

Prefilled dual-chamber syringe kit

Store below 86°F (30°C); do not freeze.¹

Vial kit:

Store at 77°F (25°C).¹

Kit Storage (Excursions Permitted)

Prefilled dual-chamber syringe kit

None specified in the PI¹

Vial kit:

Excursions permitted between 59°F and 86°F (15°C and 30°C).¹

Kit Storage (Protect from Light)

Prefilled dual-chamber syringe kit

Yes¹

Vial kit:

None stated in the PI

Kit Storage (Other Requirements)

Not stated in PI

Temperature Requirements for Drug Preparation

Room Temperature¹

Preparation Instructions

For prefilled dual-chamber syringe kit:

Push, then rotate the plunger to release the diluent (SWFI) from the rear chamber up into the front chamber containing the lyophilized powder. Vertically shake the syringe vigorously for 20 seconds until uniformly milky-white.¹

For vial kit:

Transfer the diluent (SWFI) from its vial into the vial containing the lyophilized powder using aseptic technique and the supplied syringe and pre-attached needle. Shake the vial vigorously for 30 seconds until uniformly milky-white.¹ For the 160-mg dose, use 0.8 mL of SWFI.¹ For the 200-mg dose, use 1 mL of SWFI.¹ For the 300-mg dose, use 1.5 mL of SWFI.¹ For the 400-mg dose, use 1.9 mL of SWFI.¹

Requirements Once Prepared or Reconstituted

Prefilled dual-chamber syringe kit:

Once reconstituted, administer immediately.¹

Vial kit:

Once reconstituted, administer immediately.¹If the injection is not performed immediately, keep the vial containing the reconstituted drug at room temperature and then shake the vial vigorously for at least 60 seconds to resuspend the drug prior to injection.¹Do not store the reconstituted suspension in a syringe.¹