Healthcare Settings

SPRAVATO® REMS Healthcare Setting Enrollment

Healthcare settings must be certified in the SPRAVATO® REMS in order to prescribe product. SPRAVATO® is intended for patient administration under the direct observation of a healthcare provider, and patients are required to be monitored by a healthcare provider for at least 2 hours. SPRAVATO® must never be dispensed directly to a patient for home use.

How does my Healthcare Setting become certified in the
SPRAVATO® REMS?

Step 1: Designate an Authorized Representative to oversee implementation and compliance with the REMS requirements

Step 2: Review the following materials:

  • SPRAVATO® REMS Fact Sheet
  • SPRAVATO® Medication Guide
  • SPRAVATO® Prescribing Information
  • SPRAVATO® Instructions for Use

Step 3: Complete and submit the SPRAVATO® REMS Healthcare Setting Enrollment Form to the REMS

OnlineBy Fax

PDFs for Download: Resources for Healthcare Settings

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.

This site is published by Janssen Pharmaceuticals Inc., which is solely responsible for its contents. This site is intended for use by healthcare professionals in the United States and Puerto Rico. Janssen Pharmaceuticals, Inc. recognizes that the internet is a global communications medium; however, laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. The Prescribing Information included here may not be appropriate for use outside the United States and Puerto Rico.

Third party trademarks used herein are trademarks of their respective owners.

Distributed by: Janssen Pharmaceuticals, Inc, Titusville, NJ 08560

©Janssen Pharmaceuticals, Inc. 2019 03/2019