What is the SPRAVATO™ REMS (Risk Evaluation and Mitigation Strategy)?

Because of the risks associated with SPRAVATO™, the Food and Drug Administration (FDA) has required a special program called a Risk Evaluation and Mitigation Strategy (REMS). As part of the REMS, your doctor will discuss the risks of misuse, abuse, sedation (feeling sleepy), dissociation (feeling disconnected from yourself, including thoughts, feelings, and things around you) while on SPRAVATO™ with you. Both you and your doctor must sign the Patient Enrollment Form for you to receive SPRAVATO™. Your doctor will provide a copy of the signed form to the SPRAVATO™ REMS.

How do I enroll in the SPRAVATO™ REMS?

If your healthcare provider and you have both agreed that SPRAVATO™ is the appropriate treatment for you, you will need to enroll in the SPRAVATO™ REMS in order to receive treatment with SPRAVATO™.

These are the steps to take in partnership with your
healthcare provider:

Step 1: Read the SPRAVATO™ Medication Guide and Instructions for Use. Your healthcare provider will review specific risk and safety information of SPRAVATO™ with you and describe how to use the product

Step 2: Ask your healthcare provider any questions you have about taking SPRAVATO™ and about the SPRAVATO™ REMS

Step 3: Make sure you understand:

  • A. How to enroll and take part in the SPRAVATO™ REMS
  • B. The benefits and risks of SPRAVATO™
  • C. That each time you receive SPRAVATO™:
    • You will need to use SPRAVATO™ Nasal Spray yourself under direct observation of a healthcare provider in a healthcare setting, such as a doctor’s office, clinic, or hospital
    • You will be monitored by a healthcare provider for at least 2 hours; the healthcare provider will then decide when you are ready to leave the healthcare setting
    • After treatment with SPRAVATO™, do not drive, operate heavy machinery, or do anything where you need to be completely alert until the next day following a restful sleep

Step 4: Together with your healthcare provider complete and sign the SPRAVATO™ REMS Patient Enrollment Form.

Your healthcare provider will fill out most of the enrollment form for you and will send the form to SPRAVATO™ REMS

PDFs for Download: Resources for Patients