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How to Set Up a REMS-certified SPRAVATO® Treatment Center

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.

TRD=treatment-resistant depression.

SPRAVATO® (esketamine) CIII Nasal Spray

TRD=treatment-resistant depression.

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Why Does SPRAVATO® 
Require a 
REMS-certified SPRAVATO® 
Treatment Center?

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

LEARN MORE 
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.

Reference:

1. SPRAVATO® [Prescribing Information]. 
Titusville, NJ: Janssen Pharmaceuticals, Inc. February 2020.

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Find Out What You Need to Consider

Need a SPRAVATO® REMS-certified pharmacy? 
Call 855-382-6022

Need Access and Reimbursement Support?
Call a Janssen CarePath Care Coordinator at 844-777-2828,
 Monday – Friday, 8:00 AM to 8:00 PM ET
or visit JanssenCarePath.com