Disposal and Returns

USED DEVICES:
Both sprays have been expelled from device

  • Used devices should be disposed as medical waste per local, state and federal regulations for controlled substances

UNUSED DEVICES:
The patient hasn’t been treated with SPRAVATO™ within 14 days of receipt of patient-labeled product dispensed from a pharmacy or PARTIALLY USED DEVICES: Patient received one spray and then either the patient or HCP decided not to continue with treatment

  • You can use the SPRAVATO™ Safe Returns® Program to dispose of unused or partially used devices by calling Stericycle at 1-888-912-7348. See next page for the details on the SPRAVATO™ Safe Returns® Program

DEVICE MALFUNCTION:
Device prematurely expelled medication or device won’t expel medication

  • Healthcare professionals should call Janssen Medical Information at 1-800-JANSSEN to report a product quality complaint

  • The Medical Information team will talk you through the complaint submission, the next steps to consider for obtaining product for patient administration to prevent missed doses (if possible), and the process for returning the device

EXPIRED PRODUCT:
Product has expired based on expiration date on box and blister pack

  • Coordinate with the pharmacy that sent you the product to return old devices and receive new devices
  • If you purchased the product from a distributor or wholesaler you can learn about the returns process by calling INMAR at 1-800-967-5952 or by reviewing Janssen's Returns Policy (https://www.jom.com/sites/default/files/returned_goods_policy.pdf )
    • The policy outlines expired product returns eligibility criteria as well as the process to submit the returns request

SPRAVATO™ Safe Returns® Program

    What is it?
    • Janssen has partnered with Stericycle, a reverse distribution company, to support the safe return and destruction of partially used or unused dispensed patient-labeled product at no cost to the healthcare provider
    When to use it?
    • If you have partially used devices – meaning the patient received one spray and then either the patient or HCP decided not to continue with treatment
    • Pharmacy dispensed patient-labeled product to your healthcare setting and the patient hasn’t been treated with SPRAVATO™ within 14 days of receipt of patient-labeled product dispensed from a pharmacy
    How to use it?
    • You can utilize the SPRAVATO™ Safe Returns® Program by calling Stericycle at 1-888-912-7348
    What to expect?
    • When you call Stericycle for the Safe Returns® Program they will capture your name, practice name, address, DEA# reason for return, # of units, NDC and description, lot # & expiration date and send you a pre-populated packing slip (shipping label)
    • Package the devices and send via UPS Ground Transportation using the packing slip provided by Stericycle

SPRAVATO™ Returns and Disposal FAQs

  • I want to have packing slips on hand so when I need to use Safe Returns® I don’t have to wait for a slip. Why can’t the SPRAVATO™ Safe Returns® Program send me packing slips just in case I have a patient no show?
    • As SPRAVATO™ is a controlled substance, there are tracking requirements to ensure quantity being returned is actually what is 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
  • Can the SPRAVATO™ Safe Returns® Program send me the packaging as well as the packing slip?
    • No. At this time SPRAVATO™ Safe Returns® Program can only send you the packing slip
  • How long will it take after I call Stericycle for me to receive the packing slip?
    • It should take no more than 2 days. If you don’t receive the slip by then, please call Stericycle and reference your order #
  • What to do during a treatment session if device malfunctions or falls on the floor:
    • Healthcare professionals should call Janssen Medical Information at 1-800-JANSSEN
    • The Medical Information team will talk you through the complaint submission (if applicable), the next steps to consider for obtaining product for patient administration to prevent missed doses (if possible), and the process for returning the device (if applicable)

Indication

Indication

Indication

Indication for large populates

Important Safety Information