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SPRAVATO® REMS Certification | SPRAVATO® (esketamine) HCP

Treatment Center Operations

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?

Office build representing a certified healthcare setting

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.

Review the REMS program requirements

Download the REMS Considerations for Treatment Centers resource

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

Number 1 in orange circle

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

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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

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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).