Perseris^®

• Schizophrenia in adults⁹

Initiation Regimen Required for Schizophrenia

No⁹

Oral Supplementation Required During Initiation for Schizophrenia

No⁹

Initiation Regimen for Schizophrenia

For patients who have never taken risperidone, establish tolerability with oral risperidone prior to initiating PERSERIS.

Initiate PERSERIS at a dose of 90 mg or 120 mg once monthly by subcutaneous injection. Do not administer more than one dose (90 mg or 120 mg total) per month.

For patients switching from oral risperidone:

• 3 mg of oral risperidone per day, administer a 90 mg PERSERIS dose one day after the last oral risperidone dose.
• 4 mg of oral risperidone per day, administer a 120 mg PERSERIS dose one day after the last oral risperidone dose.

Disease States

• Schizophrenia in adults⁹

Reconstitution Required

Yes⁹

How Supplied

Powder for reconstitution (white to off-white to yellow solid)
+
Delivery System (colorless to yellow solution)⁹

Preparation Instructions

Tap the barrel of the powder syringe to dislodge any packed powder, as powder can become packed during shipping.⁹ Place liquid syringe on top of the powder syringe, twist to connect, and then pass the contents back and forth between the syringes (using the plungers) to mix.⁹This process must be done gently for 5 cycles, and then more vigorously for an additional 55 cycles.⁹When fully mixed, the product should be a cloudy suspension that is uniform in color (white to yellow-green).

If any clear areas remain in the mixture, continue to mix until there is uniform color distribution.⁹

On completion of the mixing cycles, transfer all contents into the liquid syringe, then while maintaining slight pressure on the powder syringe plunger, pull back the liquid syringe plunger and twist the syringes apart. Attach the safety needle and check for uniform color and that it is free from foreign particles.⁹

Requirements Once Prepared or Reconstituted

None stated in PI

Number of Dosing Options Available

2⁹

Preparation Kits Available

Single-dose two-syringe mixing system kit (90 mg or 120 mg)⁹

Dose Strengths

• 90 mg
• 120 mg⁹

Equivalencies

• PERSERIS 90 mg Q1M = 3 mg PO risperidone QD
• PERSERIS 120 mg Q1M = 4 mg PO risperidone QD⁹

Total mass of the reconstituted product delivers the following amounts of active drug:

• 600 mg total mass of reconstituted product in 0.6 mL contains 90 mg risperidone
• 800 mg total mass of reconstituted product in 0.8 mL contains 120 mg risperidone⁹

Maintenance Dose for Schizophrenia

90 mg or 120 mg Q1M⁹

Q1M⁹

0.6 mL (90 mg dose) - 0.8 mL (120 mg dose):⁹

• 0.6 mL (90 mg dose)
• 0.8 mL (120 mg dose)⁹

Needle Lengths

5/8⁹

Needle Gauges

18⁹

Injection Site(s)

SC only (abdomen or back of the upper arm)⁹

Deltoid Administration (Needle Gauge & Length)

n/a

Gluteal Administration (Needle Gauge & Length)

n/a

Subcutaneous Administration (Needle Gauge & Length)

18-gauge, 5/8-inch safety needle⁹

How Supplied

Powder for reconstitution (white to off-white to yellow solid)
+
Delivery System (colorless to yellow solution)⁹

Preparation Kits Available

Single-dose two-syringe mixing system kit

• 90 mg
• 120 mg⁹

Kit Contents

1 syringe prefilled with risperidone powder
+
1 syringe prefilled with the liquid delivery system
+
1 safety needle for drug administration⁹

Kit Storage (Refrigeration Required)

Yes⁹

Kit Storage (Specific Temperature Requirements)

Store dose kit in the refrigerator (36°F-46°F; 2°C-8°C).⁹

Kit Storage (Excursions Permitted)

May be stored unopened in original packaging at room temperature (68°F-77°F; 20°C-25°C) for up to 30 days prior to administration. After removal from the refrigerator, use within 30 days or discard.⁹

Kit Storage (Protect from Light)

Not stated in PI

Kit Storage (Other Requirements)

Not stated in PI

Temperature Requirements for Drug Preparation

Allow dose kit package to come to room temperature (20°C-25°C; 68°F-77°F) for at least 15 minutes prior to preparation.⁹

Preparation Instructions

Tap the barrel of the powder syringe to dislodge any packed powder, as powder can become packed during shipping.⁹ Place liquid syringe on top of the powder syringe, twist to connect, and then pass the contents back and forth between the syringes (using the plungers) to mix.⁹This process must be done gently for 5 cycles, and then more vigorously for an additional 55 cycles.⁹When fully mixed, the product should be a cloudy suspension that is uniform in color (white to yellow-green).

If any clear areas remain in the mixture, continue to mix until there is uniform color distribution.⁹

On completion of the mixing cycles, transfer all contents into the liquid syringe, then while maintaining slight pressure on the powder syringe plunger, pull back the liquid syringe plunger and twist the syringes apart. Attach the safety needle and check for uniform color and that it is free from foreign particles.⁹

Requirements Once Prepared or Reconstituted

None stated in PI