SPRAVATO® REMS

(Risk Evaluation and Mitigation Strategy)

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

A REMS is a strategy to manage known or potential risks associated with a drug and is required by the U.S. Food and Drug Administration (FDA) to ensure that the benefits of the drug outweigh its risks.

SPRAVATO® (esketamine) nasal spray CIII is available only through a restricted distribution program called the SPRAVATO® REMS because of the risks of serious adverse outcomes resulting from sedation and dissociation caused by SPRAVATO administration, and abuse and misuse of SPRAVATO. SPRAVATO® is intended for use only in a certified Healthcare Setting.

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.

Program Requirements

Inpatient Healthcare Setting

Inpatient Healthcare Settings must be certified in the SPRAVATO® REMS in order to treat patients with SPRAVATO®

Inpatient Healthcare Setting Certification

Outpatient Healthcare Setting

Outpatient Healthcare Settings must be certified in the SPRAVATO® REMS in order to treat patients with SPRAVATO®

Outpatient Healthcare Setting Certification

Pharmacy

Pharmacies must be certified in the SPRAVATO® REMS in order to dispense SPRAVATO®

Pharmacy Certification

Patient

Patients must be enrolled in the SPRAVATO® REMS in order to receive SPRAVATO® treatment in an Outpatient Healthcare Setting

Patient
Enrollment

SPRAVATO® Indication

SPRAVATO® is a non-competitive N-methyl D-aspartate (NMDA) receptor antagonist indicated, in conjunction with oral antidepressant, for the treatment of:
  • Treatment-resistant depression (TRD) in adults.
  • Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior.

SPRAVATO® is only available through select restricted distribution channels.

If you have any questions about the SPRAVATO® REMS or need help with certification or enrollment, call 1-855-382-6022
Monday - Friday 8AM - 8PM ET

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. 2020 08/2020