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Join the Nationwide Network of SPRAVATO® Treatment Centers

The SPRAVATO® REMS program supports safe and appropriate use for treatment of patients, with REMS-certified treatment centers playing an integral role in the patient experience
Begin exploring ways to efficiently start and operate your treatment center to deliver SPRAVATO® for your patients
Explore resources and considerations to help inform your local healthcare community about the availability of SPRAVATO® at your treatment center

REMS=Risk Evaluation and Mitigation Strategy.

SPRAVATO® REMS

Learn more about the SPRAVATO® REMS program and the steps for becoming and maintaining your certification to treat appropriate patients with SPRAVATO®.

What Is REMS?

A Risk Evaluation and Mitigation Strategy (REMS) manages known or potential risks associated with a drug and is required by the US Food and Drug Administration (FDA) to ensure that the benefits of the drug outweigh its risks.

Due to the risks of serious adverse outcomes resulting from sedation, dissociation and respiratory depression caused by SPRAVATO® administration, as well as the risks of abuse and misuse, SPRAVATO® is available only through a restricted distribution program called the SPRAVATO® REMS. The SPRAVATO® REMS supports safe and appropriate use for treatment of patients.

SPRAVATO® is intended for patient administration under the direct observation of a healthcare provider. SPRAVATO® is intended for use only in a certified healthcare setting and must never be dispensed directly to a patient for home use.

What to know about becoming a REMS-Certified SPRAVATO® treatment center

Watch the video below for an overview of considerations before setting up a REMS-certified SPRAVATO® treatment center.

Steps for SPRAVATO® REMS Certification

Identify your healthcare setting type and determine which staff member will be designated as the Authorized Representative, the individual responsible for ensuring compliance with the SPRAVATO® REMS program

Determine your acquisition method (specialty pharmacy, direct purchase from an authorized specialty distributor [ie, buy and bill], or both), and complete the REMS enrollment online

Comply with the requirements of the SPRAVATO® REMS program, submit all mandatory documentation (eg, Patient Monitoring Form), and maintain records of training and processes

Review the REMS Overview and enroll your treatment center at SPRAVATOrems.com or, if you have questions, call 1-855-382-6022 (Monday to Friday, 8 AM to 8 PM ET).