Patients

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 healthcare provider 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 healthcare provider must sign the Patient Enrollment Form  for you to receive SPRAVATO® in an outpatient medical office or clinic, excluding emergency departments. Your healthcare provider 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® in an outpatient medical office or clinic, excluding emergency departments.

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

Step 1: 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 an outpatient medical office or clinic, excluding emergency departments.
    • 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 2: Together with your healthcare provider complete and sign the SPRAVATO® REMS Patient Enrollment Form:

  • Your healthcare provider will fill out most of the form for you and will send the form to SPRAVATO® REMS.

Step 3: Ask your healthcare provider any questions you have about taking SPRAVATO® and about the SPRAVATO® REMS.

For SPRAVATO® REMS Program information contact: Phone: 1-855-382-6022 Fax: 1-877-778-0091

Healthcare providers should report suspected adverse events or product quality complaints associated with SPRAVATO® to Janssen at 1-800-JANSSEN (1-800-526-7736) or the FDA at 1-800-FDA-1088 or online at www.fda.gov/medwatch.

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©Janssen Pharmaceuticals, Inc. 2020 08/2020