Are there special instructions from the manufacturer for administering Uzedy (generic name) to patients, particularly those with a history of bleeding disorders or other medical conditions?

Special Manufacturer Instructions for Uzedy Administration

Uzedy must be administered subcutaneously only (not intramuscularly) in the abdomen or upper arm, and requires specific preparation steps including allowing the syringe to reach room temperature for at least 30 minutes and forcefully flicking the syringe three times to move the air bubble to the cap before injection. 1

Critical Pre-Administration Requirements

Temperature and Preparation

• Remove Uzedy from refrigerated storage and allow it to sit at room temperature (20°C to 25°C [68°F to 77°F]) for at least 30 minutes before administration 1
• The medication is solid at refrigerated temperatures and must reach room temperature prior to use 1
• Do not warm by any other method and keep protected from light 1
• Verify the drug appears white to off-white, opaque in color, and free from non-white particulate matter 1

Mandatory Bubble Movement Step

• Hold the syringe firmly by the white collar and flick forcefully downward three times with a full arm whipping motion to move the air bubble to the cap 1
• This step is critical to ensure complete dosing, as failure to move the bubble could result in incomplete dosage delivery 1
• Standing while performing this action may help achieve the required force 1
• The bubble will appear partially opaque; hold the syringe up to light or against a dark backdrop to verify proper positioning 1

Injection Site Specifications

Approved Anatomical Locations

• Stomach area (abdomen) around the belly button 1
• Back and outer area of the upper arms 1
• Do not inject into any other anatomical location 1

Site Selection Restrictions

• Avoid areas that are tender, red, bruised, callused, tattooed, hard, or have scars or stretch marks 1

Administration Technique

Injection Process

• Clean the injection site with an alcohol wipe 1
• Pinch at least 1 inch of cleaned skin 1
• Insert the needle into subcutaneous tissue (angle depends on amount of subcutaneous tissue present) 1
• Release the pinched skin once the needle is in the subcutaneous tissue 1

Dose Delivery Requirements

• Push the plunger using a slow, firm, and steady push until the entire dose is delivered 1
• Inject the entire dose at one time without interruption 1
• Uzedy is viscous and resistance will be experienced during dose delivery 1
• Do not use excessive force attempting to deliver faster 1
• Wait 2-3 seconds after the entire dose is delivered before removing the needle 1
• Slowly pull the needle out at the same angle as insertion 1

Special Populations and Precautions

Bleeding Disorder Considerations

While the FDA label does not provide specific contraindications for bleeding disorders, general principles from immunization guidelines indicate that subcutaneous injections carry lower bleeding risk than intramuscular injections in patients with bleeding disorders or on anticoagulation therapy 2

• For patients with bleeding disorders, a fine needle (<23 gauge) should be used, with firm pressure applied to the site without rubbing for >2 minutes 2
• Patients or family should be instructed concerning the risk of hematoma from injection 2

Healthcare Professional Administration Only

• Uzedy must be administered by a healthcare professional only 1
• Always wear gloves as a universal precaution 1
• Do not substitute any components of the kit for administration 1

Safety and Disposal

Post-Injection Safety

• Activate the safety needle shield immediately after withdrawal using either surface activation (place on flat surface and pull syringe backward) or finger/thumb activation (press shield forward) 1
• An audible click confirms the needle safety shield is locked 1
• Dispose of all syringe components in a suitable sharps container 1

Tolerability Requirement

• Establish tolerability with oral risperidone prior to initiating Uzedy 1