Uzedy

Indications and Usage (

UZEDY is an atypical antipsychotic indicated:

• for the treatment of schizophrenia in adults. (
  1.1 Schizophrenia

  UZEDY is indicated for the treatment of schizophrenia in adults

  .
  )
• as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. (
  1.2 Bipolar Disorder

  UZEDY is indicated as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder in adults.
  )

• Establish tolerability with oral risperidone prior to initiating UZEDY. (
  2.1 General Administration Information

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

  UZEDY must be administered by a healthcare professional as an abdominal or upper arm subcutaneous injection. Do not administer UZEDY by any other route.

  For detailed preparation and administration instructions,

  see Dosage and Administration

  .
  )
• Administer UZEDY by subcutaneous injection in the abdomen or upper arm by a healthcare professional. Do not administer by any other route. (
  2.1 General Administration Information

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

  UZEDY must be administered by a healthcare professional as an abdominal or upper arm subcutaneous injection. Do not administer UZEDY by any other route.

  For detailed preparation and administration instructions,

  see Dosage and Administration

  .
  )
• See Full Prescribing Information for important preparation and administration information. (
  2.7 Preparation and Administration Instructions

  • Read the instructions for preparation and administration below before administering UZEDY.
  • For subcutaneous injection only. Do not inject by any other route.
  • To be administered by a healthcare professional only.
  • Allow UZEDY to come to room temperature for at least 30 minutes prior to administration.
  • As a universal precaution, always wear gloves.

  STEP 1

  Check to make sure UZEDY kit contains:

  • One sterile single-dose, prefilled glass syringe
  • One sterile 21G x 5/8” needle

  Do not substitute any components of the kit for administration.

  

  STEP 2

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

  Note: UZEDY is a solid at refrigerated temperatures and must reach room temperature prior to administration. Do not warm any other way and keep protected from light.

  

  STEP 3

  Check that the drug in the syringe is white to off-white, opaque in color, and free from non-white particulate matter. Check that the pouch label states the needle size is 21G x 5/8”.

  Do not use if any component of the kit is damaged or if the expiration date has passed.

  

  STEP 4

  Expose the safety needle hub by peeling back the paper tab of the needle pouch. Set aside for use in Step 7.

  STEP 5

  IMPORTANT: This step must be performed to ensure complete dosing. 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 dosage.

  Firmly hold the syringe by the white collar.

  

  Flick Syringe Forcefully Three 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.
  • Repeat this action 3 times to ensure that the bubble is at the cap of the syringe.

  Note: 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 Step 5 until it is.

  

  STEP 6

  Hold the syringe vertically by the white collar. Bend and snap off the cap.

  Do not touch the syringe tip to avoid contamination.

  

  STEP 7

  Attach the Needle to the Syringe

  • Hold the syringe vertically with the white collar at the top.
  • Push the green hub of safety needle inside the white collar of syringe and rotate the safety needle while holding the white collar until secure and tight.

  Inspect the needle connection to check that the hub is not damaged.

  

  STEP 8

  Select Injection Site from the Following Areas:

  • Stomach area (abdomen) around the belly button
  • Back and outer area of the upper arms

  Do not inject UZEDY anywhere except in the areas specified above.

  Do not inject UZEDY into an area that is tender, red, bruised, callused, tattooed, hard, or has scars or stretch marks.

  

  STEP 9

  Clean the Injection Site with an alcohol wipe.

  STEP 10

  Remove the needle sheath by pulling the needle sheath away from the green hub to expose the needle.

  Do not expel any visible air bubble.

  

  STEP 11

  Pinch at least 1 inch of the area of cleaned skin with your free hand.

  

  STEP 12

  Insert the needle into subcutaneous tissue (actual angle of injection will depend on the amount of subcutaneous tissue). Do not apply pressure to the plunger.

  

  STEP 13

  Release the pinched skin once the needle is in the subcutaneous tissue.

  

  STEP 14

  Inject the Medication

  • Push on the plunger using a slow, firm, and steady push until the entire dose is delivered.
  • Inject the entire dose at one time, without interruption.
  • Check that the plunger stopper is at the White Collar.

  IMPORTANT: UZEDY is viscous. Resistance will be experienced during dose delivery. Do not use excessive force in an attempt to deliver UZEDY faster.

  

  STEP 15

  Wait 2-3 seconds after the entire dose is delivered before removing the needle. Slowly pull the needle out from the injection site at the same angle as insertion.

  

  STEP 16

  Activate (lock) the safety needle shield using one of the following methods:

  • Surface Activation:
    Place the needle shield on a flat surface and pull the syringe backward until the needle shield covers the needle tip.

  • Finger/Thumb Activation:
    Press either your thumb or finger on the needle shield and push it forward until the needle shield covers the needle tip.

  There will be an audible click when the needle safety shield is locked.

  Dispose of all syringe components in a suitable sharps container.

  
  
  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  )

• Initiate UZEDY at the clinically appropriate dose using the following table. (
  2.2 Dosage Recommendations for the Treatment of Schizophrenia

  To start UZEDY for the treatment of schizophrenia, switch from oral daily risperidone. Initiate UZEDY, as either a once monthly injection or a once every 2 month injection, the day after the last dose of oral therapy. See

  Table 1

  to determine how to switch from oral risperidone to UZEDY once monthly (50 mg, 75 mg, 100 mg, or 125 mg) or once every 2 months (100 mg, 150 mg, 200 mg, or 250 mg) given via abdominal or upper arm subcutaneous injection. Neither a loading dose nor supplemental oral risperidone doses are recommended when switching.

  Table 1: Dosage Recommendations for Switching from Daily Oral Risperidone to UZEDY Given Once Monthly or Once Every 2 Months

  Comparable Daily Oral Risperidone Therapy	UZEDY Dosage Once Monthly	UZEDY Dosage Once Every 2 Months
  2 mg	50 mg	100 mg
  3 mg	75 mg	150 mg
  4 mg	100 mg	200 mg
  5 mg	125 mg	250 mg

  Patients can switch between doses of UZEDY once monthly and once every 2 months by administering the first dose of the new dosing regimen on the next scheduled date of administration in the original dosing regimen. Revise the dose administration schedule to reflect the change.

  
  
  
  )

• Following establishment of tolerability with oral risperidone, initiate UZEDY at the clinically appropriate dose using the following table. (
  2.3 Dosage Recommendations for Maintenance Treatment of Bipolar I Disorder

  Following establishment of tolerability with oral risperidone, start UZEDY as a once monthly injection for monotherapy or adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder, according to the dosage recommendations in

  Table 2

  . UZEDY once every 2 months injection is not recommended for the maintenance treatment of bipolar I disorder.

  Table 2: Dosage Recommendations for Switching from Daily Oral Risperidone to UZEDY Given Once Monthly

  Comparable Daily Oral Risperidone Therapy	UZEDY Dosage Once Monthly
  2 mg	50 mg
  3 mg	75 mg
  4 mg	100 mg

  For patients currently receiving risperidone long acting intramuscular injectable given once every 2 weeks, switch to UZEDY as a once monthly subcutaneous injection, starting at least 5 weeks after the last dose of risperidone long acting intramuscular injectable given once every 2 weeks. Refer to

  Table 3

  to determine how to switch from risperidone long acting injectable given once every 2 weeks to UZEDY once monthly (50 mg, 75 mg, 100 mg) subcutaneous injection given via abdominal or upper arm. Neither a loading dose nor supplemental oral risperidone doses are recommended when initiating UZEDY.

  Table 3: Dosage Recommendations for Switching From Another Risperidone Long-Acting Intramuscular Injection Given Once Every 2 Weeks To UZEDY Given Once Monthly

  Another Risperidone Long-Acting Intramuscular Injection Given Once Every 2 Weeks	UZEDY Dosage Once Monthly
  25 mg	50 mg
  37.5 mg	75 mg
  50 mg	100 mg

  
  
  
  )

• For patients currently receiving risperidone long acting intramuscular injectable given once every 2 weeks, switch to UZEDY as a once monthly injection, starting at least 5 weeks after the last dose of risperidone long acting injectable given once every 2 weeks. (
  2.3 Dosage Recommendations for Maintenance Treatment of Bipolar I Disorder

  Following establishment of tolerability with oral risperidone, start UZEDY as a once monthly injection for monotherapy or adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder, according to the dosage recommendations in

  Table 2

  . UZEDY once every 2 months injection is not recommended for the maintenance treatment of bipolar I disorder.

  Table 2: Dosage Recommendations for Switching from Daily Oral Risperidone to UZEDY Given Once Monthly

  Comparable Daily Oral Risperidone Therapy	UZEDY Dosage Once Monthly
  2 mg	50 mg
  3 mg	75 mg
  4 mg	100 mg

  For patients currently receiving risperidone long acting intramuscular injectable given once every 2 weeks, switch to UZEDY as a once monthly subcutaneous injection, starting at least 5 weeks after the last dose of risperidone long acting intramuscular injectable given once every 2 weeks. Refer to

  Table 3

  to determine how to switch from risperidone long acting injectable given once every 2 weeks to UZEDY once monthly (50 mg, 75 mg, 100 mg) subcutaneous injection given via abdominal or upper arm. Neither a loading dose nor supplemental oral risperidone doses are recommended when initiating UZEDY.

  Table 3: Dosage Recommendations for Switching From Another Risperidone Long-Acting Intramuscular Injection Given Once Every 2 Weeks To UZEDY Given Once Monthly

  Another Risperidone Long-Acting Intramuscular Injection Given Once Every 2 Weeks	UZEDY Dosage Once Monthly
  25 mg	50 mg
  37.5 mg	75 mg
  50 mg	100 mg

  
  
  
  )
• Switch to UZEDY at the clinically appropriate dose using the following table. (
  2.3 Dosage Recommendations for Maintenance Treatment of Bipolar I Disorder

  Following establishment of tolerability with oral risperidone, start UZEDY as a once monthly injection for monotherapy or adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder, according to the dosage recommendations in

  Table 2

  . UZEDY once every 2 months injection is not recommended for the maintenance treatment of bipolar I disorder.

  Table 2: Dosage Recommendations for Switching from Daily Oral Risperidone to UZEDY Given Once Monthly

  Comparable Daily Oral Risperidone Therapy	UZEDY Dosage Once Monthly
  2 mg	50 mg
  3 mg	75 mg
  4 mg	100 mg

  For patients currently receiving risperidone long acting intramuscular injectable given once every 2 weeks, switch to UZEDY as a once monthly subcutaneous injection, starting at least 5 weeks after the last dose of risperidone long acting intramuscular injectable given once every 2 weeks. Refer to

  Table 3

  to determine how to switch from risperidone long acting injectable given once every 2 weeks to UZEDY once monthly (50 mg, 75 mg, 100 mg) subcutaneous injection given via abdominal or upper arm. Neither a loading dose nor supplemental oral risperidone doses are recommended when initiating UZEDY.

  Table 3: Dosage Recommendations for Switching From Another Risperidone Long-Acting Intramuscular Injection Given Once Every 2 Weeks To UZEDY Given Once Monthly

  Another Risperidone Long-Acting Intramuscular Injection Given Once Every 2 Weeks	UZEDY Dosage Once Monthly
  25 mg	50 mg
  37.5 mg	75 mg
  50 mg	100 mg

  
  
  
  ).

Extended-release injectable suspension: sterile, white to off-white opaque viscous suspension available in the following strengths of risperidone: 50 mg/0.14 mL, 75 mg/0.21 mL, 100 mg/0.28 mL, 125 mg/0.35 mL, 150 mg/0.42 mL, 200 mg/0.56 mL, and 250 mg/0.7 mL.

Pregnancy: May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. (