summary

• Because of the risks of serious adverse outcomes resulting from sedation, dissociation, and abuse and misuse, SPRAVATO (esketamine) nasal spray is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS).¹
  • For additional information or questions about the REMS, call 1-855-382-6022 or visit www.SPRAVATOrems.com.
• Prior to use, check that the device indicator shows 2 green dots in the display window. If it does not, dispose of the device and get a new one.¹
• SPRAVATO nasal spray devices must be handled with adequate security, accountability, and proper disposal as medical waste (eg, sharps container), per facility procedure for used Schedule III drug product and per applicable federal, state, and local regulations.¹ According to recommendations from the Centers for Disease Control and Prevention (CDC) for environmental cleaning and disinfection for SARS-CoV-2, management of medical waste should be performed in accordance with routine procedures.²

Managing Used, Partially Used and Unused Devices

USED DEVICES

For SPRAVATO devices that have been used by the patient, it should be disposed of as medical waste according to local, state, and federal regulations for controlled substances.

UNUSED DEVICES OR PARTIALLY USED DEVICES

If the SPRAVATO device has not been used by the patient within 14 days of receipt of the patient-labeled product dispensed from a pharmacy, then disposal of the product is required.

If the patient received 1 spray and then it was decided not to continue with treatment by either the patient or the healthcare provider, then disposal of the partially used product is required.

Call the SPRAVATO Disposal Program at 888-912-7348 to dispose of unused or partially used devices if your healthcare setting is not equipped to do so.

EXPIRED PRODUCT

When the product is past the expiration date printed on the box and blister pack, coordinate with the pharmacy that sent you the expired product to exchange it for new product.

If you purchased the product from a distributor or wholesaler, call INMAR^® at 800-967-5952 to learn about the returns process and eligibility criteria.  You may also review the Janssen Returns Policy by following this link: https://www.janssen.com/sites/www_janssen_com_usa/files/jom_return_goods_policy-effective-5-16-2022.pdf.

HANDLING DEVICE MALFUNCTIONS

If the device will not expel or has prematurely expelled medication, then a healthcare provider should call Janssen Medical Information at 1-800-JANSSEN to report a product quality complaint.

Your staff should determine how to obtain more product to prevent the patient from missing doses (if possible) and follow the process above for returning the device.

Calling the SPRAVATO DISPOSAL Program

• When you call SPRAVATO Disposal Program they will capture: your name, practice name, address, Drug Enforcement Administration (DEA) number, reason for return, number of units, National Drug Code (NDC) and description, lot number and expiration date, and send you a pre-populated packing slip (shipping label).
• Package the devices and send via United Parcel Service (UPS) Ground Transportation using the packing slip provided by SPRAVATO Disposal Program. Due to Patient Confidentiality laws, you will be required to remove and/or black out all patient information that is present on the unused or partially used product prior to mailing the product to Sedgwick.
• As SPRAVATO is a controlled substance, there are tracking requirements to ensure quantity being returned is what is actually received. In addition, quantity is required to generate the packing slip and tracking of the return. The program can only process orders and send packing slips for a specific patient-labeled product.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENTDrug File (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 05 July 2023.