Uzedy^®

• Schizophrenia in adults¹⁰

Initiation Regimen Required for Schizophrenia

Neither a loading dose nor supplemental oral risperidone are recommended when switching to UZEDY

Oral Supplementation Required During Initiation for Schizophrenia

Neither a loading dose nor supplemental oral risperidone are recommended when switching to UZEDY

Initiation Regimen for Schizophrenia

Initial UZEDY dose is based on prior daily PO risperidone dose:

• 2 mg QD PO risperidone --> Initiate UZEDY at 50 mg Q1M or 100 mg Q2M
• 3 mg QD PO risperidone --> Initiate UZEDY at 75 mg Q1M or 150 mg Q2M
• 4 mg QD PO risperidone --> initiate UZEDY at 100 mg Q1M or 200 mg Q2M
• 5 mg QD PO risperidone --> initiate UZEDY at 125 mg Q1M or 250 mg Q2M¹⁰

Disease States

• Schizophrenia in adults¹⁰

Reconstitution Required

No¹⁰

How Supplied

White to off-white, opaque, viscous suspension¹⁰

Preparation Instructions

UZEDY is viscous and forceful downward flicks are required to move the bubble to the cap of the syringe. Failure to move the bubble to the cap of the syringe could result in incomplete dosing.

Firmly hold the syringe by the white collar.

Flick syringe forcefully 3 times to move the bubble to the cap. Flick with a forceful downward whipping motion of your full arm to move the bubble to the cap of the syringe, and repeat this action 3 times to ensure the bubble is at the cap of the syringe. Standing while you do this may help achieve required force.

Check that the bubble is at the cap of the syringe. The bubble will appear partially opaque. Holding the syringe up to light or against a dark backdrop may improve visibility. If the bubble is not at the cap, repeat the flicking motions until it is.¹⁰

Requirements Once Prepared or Reconstituted

Once the carton has been opened, administer to the patient or discard.¹⁰

Number of Dosing Options Available

7¹⁰

Preparation Kits Available

Single-dose, prefilled syringe kit

• 50 mg
• 75 mg
• 100 mg
• 125 mg
• 150 mg
• 200 mg
• 250 mg¹⁰

Dose Strengths

• 50 mg
• 75 mg
• 100 mg
• 125 mg
• 150 mg
• 200 mg
• 250 mg¹⁰

Equivalencies

Following both once monthly (50 mg to 125 mg) and once every 2 months dosing (100 mg to 250 mg), the mean exposure of risperidone and 9-hydroxyrisperidone combined of UZEDY corresponds to that of oral risperidone (2 mg to 5 mg/day) administered over an equivalent dosing period.¹⁰

Maintenance Dose for Schizophrenia

• 50 mg - 125 mg Q1M
• 100 - 250 mg Q2M¹⁰

• Q1M (for 50 mg - 125 mg doses)
• Q2M (for 100 mg - 250 mg doses)¹⁰

0.14 mL (50 mg dose) - 0.70 mL (250 mg dose):¹⁰

• 0.14 mL (50 mg dose)
• 0.21 mL (75 mg dose)
• 0.28 mL (100 mg dose)
• 0.35 mL (125 mg dose)
• 0.42 mL (150 mg dose)
• 0.56 mL (200 mg dose)
• 0.70 mL (250 mg dose)¹⁰

Needle Lengths

5/8¹⁰

Needle Gauges

21¹⁰

Injection Site(s)

SC (abdominal; back or outer area of upper arm)¹⁰

Deltoid Administration (Needle Gauge & Length)

n/a

Gluteal Administration (Needle Gauge & Length)

n/a

Subcutaneous Administration (Needle Gauge & Length)

21 gauge, 5/8-inch needle¹⁰

How Supplied

White to off-white, opaque, viscous suspension¹⁰

Preparation Kits Available

Single-dose, prefilled syringe kit

• 50 mg
• 75 mg
• 100 mg
• 125 mg
• 150 mg
• 200 mg
• 250 mg¹⁰

Kit Contents

1 single-dose, prefilled, glass syringe
+
1 safety needle for drug administration¹⁰

Kit Storage (Refrigeration Required)

Yes¹⁰

Kit Storage (Specific Temperature Requirements)

Store in refrigerator (36°F-46°F; 2°C-8°C).¹⁰

Kit Storage (Excursions Permitted)

At room temperature (68°F-77°F; 20°C-25°C) for up to 90 days (in original, unopened packaging).

If unopened, UZEDY may be returned to refrigerated storage within 90 days. Once the carton is opened, administer UZEDY or discard.¹⁰

Kit Storage (Protect from Light)

Yes (store in original carton to protect from light).¹⁰

Kit Storage (Other Requirements)

Once the carton has been opened, administer to the patient or discard.¹⁰

Temperature Requirements for Drug Preparation

Remove the kit from refrigerated storage and allow the package to sit at room temperature (68°F-77°F; 20°C-25°C) for at least 30 minutes.

UZEDY is solid at refrigerated temperatures and viscous at room temperature. It must reach room temperature prior to administration. Do not warm in any other way and keep protected from light.¹⁰

Preparation Instructions

UZEDY is viscous and forceful downward flicks are required to move the bubble to the cap of the syringe. Failure to move the bubble to the cap of the syringe could result in incomplete dosing.

Firmly hold the syringe by the white collar.

Flick syringe forcefully 3 times to move the bubble to the cap. Flick with a forceful downward whipping motion of your full arm to move the bubble to the cap of the syringe, and repeat this action 3 times to ensure the bubble is at the cap of the syringe. Standing while you do this may help achieve required force.

Check that the bubble is at the cap of the syringe. The bubble will appear partially opaque. Holding the syringe up to light or against a dark backdrop may improve visibility. If the bubble is not at the cap, repeat the flicking motions until it is.¹⁰

Requirements Once Prepared or Reconstituted

Once the carton has been opened, administer to the patient or discard.¹⁰