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SPRAVATO® REMS Certification | SPRAVATO® (esketamine) HCP

SPRAVATO® REMS1

A Risk Evaluation and Mitigation Strategy (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.

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SPRAVATO® is available only through a restricted distribution program called the SPRAVATO® REMS because of the risks of serious adverse outcomes resulting from sedation, dissociation, respiratory depression 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.

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Healthcare Settings Type*

All REMS-certified Inpatient and Outpatient Healthcare Settings must have a healthcare provider counsel patients on the safety risk of SPRAVATO® and monitor patients post-dose.

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Inpatient Healthcare Settings

  • Covers inpatient units, inpatient pharmacy, and emergency departments
  • Before prescribing SPRAVATO® treatment, complete and submit the Inpatient Healthcare Setting Enrollment Form
  • Before starting SPRAVATO® treatment, inpatient settings are not required to enroll the patient in the SPRAVATO® REMS
  • During SPRAVATO® treatment, inpatient settings do not require the Patient Monitoring Form. Report all suspected adverse events to the SPRAVATO® REMS
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Outpatient Healthcare Settings

  • Covers outpatient medical offices and clinics
  • Before prescribing SPRAVATO® treatment, complete and submit the Outpatient Healthcare Setting Enrollment Form
  • Before starting SPRAVATO® treatment, enroll the patient by completing and submitting the Patient Enrollment Form to the SPRAVATO® REMS
  • During SPRAVATO® treatment, submit the Patient Monitoring Form and report all suspected adverse events to the SPRAVATO® REMS

*To get started, find more information on how to certify as a healthcare setting and/or pharmacy, and to view all REMS requirements and attestations by type of REMS stakeholder, visit www.SPRAVATOrems.com or call 1-855-382-6022 (Monday – Friday, 8 AM to 8 PM ET).

For additional information, please see full Prescribing Information.

Reference:

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

SPRAVATO® REMS Certification

While becoming REMS certified is a multistep process, information you need to complete the certification process can be found below and on the official SPRAVATO® REMS website.

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Scroll down to learn more about the SPRAVATO® REMS certification process and visit the SPRAVATO® REMS website for more information.

REMS=Risk Evaluation and Mitigation Strategy.

Completing the SPRAVATO® REMS Certification

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How does your outpatient treatment center become certified in the SPRAVATO® REMS?

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Designate an Authorized Representative to oversee implementation and coordinate the activities of the SPRAVATO® REMS

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Review the following materials:

  • SPRAVATO® Prescribing Information
  • SPRAVATO® REMS Program Overview
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Have the Authorized Representative complete and submit the Outpatient Healthcare Setting Enrollment Form at www.SPRAVATOrems.com, or complete the paper form and fax to the SPRAVATO® REMS at 1-877-778-0091

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Once submitted, you will be notified of certification in the SPRAVATO® REMS and you will receive information on additional requirements necessary to order and receive SPRAVATO®

To review all SPRAVATO® REMS Outpatient Healthcare Setting requirements, see the Outpatient Healthcare Setting Enrollment Form on the SPRAVATO® REMS website.

REMS=Risk Evaluation and Mitigation Strategy.

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.

REMS=Risk Evaluation and Mitigation Strategy.