How to Set Up a REMS-certified SPRAVATO® Treatment Center
Is Becoming a
SPRAVATO® Treatment Center
for Your Practice?
This site will take you step-by-step through:
REMS=Risk Evaluation and Mitigation Strategy.
What Is SPRAVATO®?
SPRAVATO® is a non-competitive N-methyl-
D-aspartate (NMDA) receptor antagonist
indicated, in conjunction with an oral antidepressant, for
the treatment of TRD in adults.1
Learn more about SPRAVATO® at www.spravatohcp.com.
Why Does SPRAVATO®
THE SPRAVATO® REMS CERTIFICATION IS REQUIRED BY THE FDA
A SCHEDULE III CONTROLLED SUBSTANCE
SPRAVATO® is a Schedule III controlled substance that is only administered in a medically supervised healthcare setting that is certified under the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS). SPRAVATO® is a nasal spray that is administered only under the supervision of a healthcare provider.1 This is done in accordance with federal, state, and local requirements for controlled substances.
SPRAVATO® TREATMENT CENTERS ARE REMS CERTIFIED
REMS-certified SPRAVATO® treatment centers provide the infrastructure and operational support to educate patients, provide medically supervised administration, and provide post-dose monitoring to ensure patient safety.1
ABOUT SPRAVATO® REMS
If you are interested in establishing your practice as a REMS-certified SPRAVATO® treatment center, you will need to enroll in the SPRAVATO® REMS and become certified.
What Is the SPRAVATO® REMS?
A REMS is a program required by the FDA to manage known or potential serious risks associated with a drug product.
The goal of the SPRAVATO® REMS is to mitigate the risks of serious adverse outcomes resulting from sedation and dissociation caused by SPRAVATO® administration, and the abuse and misuse of SPRAVATO®, by1:
• Ensuring that SPRAVATO® is only dispensed and administered to patients in a medically supervised healthcare setting that monitors these patients
• Ensuring pharmacies and healthcare settings that dispense SPRAVATO® are certified
• Ensuring that each patient is informed about the serious adverse outcomes resulting from sedation and dissociation and the need for monitoring
• Enrollment of all patients in the REMS (registry) to further characterize the risks and support safe use
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 after SPRAVATO® administration. SPRAVATO® must never be dispensed directly to a patient for home use.1
LEARN MORE ABOUT THE SPRAVATO® REMS CERTIFICATION PROCESS ON THE REMS WEBSITE.
1. SPRAVATO® [Prescribing Information].
Titusville, NJ: Janssen Pharmaceuticals, Inc. February 2020.