sec1-banner

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

Is Becoming a 
REMS-certified 
SPRAVATO® Treatment Center 
Right 
for Your Practice?

This site will take you step-by-step through:

Hear from other healthcare providers on how they set up their REMS-certified treatment centers to treat patients with treatment-resistant depression (TRD)

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 of1:

  • Treatment-resistant depression (TRD) in adults.
  • Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal 
    ideation or behavior.

Limitations of Use:

  • The effectiveness of SPRAVATO® in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated. Use of SPRAVATO® does not preclude the need for hospitalization if clinically warranted, even if patients experience improvement after an initial dose of SPRAVATO®.
  • SPRAVATO® is not approved as an anesthetic agent. The safety and effectiveness of SPRAVATO® as an anesthetic agent have not been established.

Learn more about SPRAVATO® at www.spravatohcp.com.

SPRAVATO® (esketamine) CIII Nasal Spray

SPRAVATO® REMS

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.

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

What are the REMS requirements?

p-number1 HEALTHCARE SETTING CERTIFICATION

All healthcare settings must be certified in the REMS in order to receive, dispense, and/or treat patients with SPRAVATO®.

p-number2 PHARMACY CERTIFICATION

All pharmacies must be certified in the REMS in order to receive and dispense SPRAVATO®.

p-number3 PATIENT ENROLLMENT

Patients in an outpatient setting must be enrolled in the REMS with their prescriber in order to receive SPRAVATO® treatment.

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.

inpaitent

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
outpaitent

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 (8AM to 8PM ET).

The REMS updates summarized above will take effect by mid-September 2020.

LEARN MORE ABOUT THE SPRAVATO® REMS CERTIFICATION PROCESS ON THE REMS WEBSITE.

How My Practice Became a REMS-certified
 SPRAVATO® Treatment Center

In this video, hear 2 different doctors share their experiences in certifying and setting up their REMS-certified SPRAVATO® treatment centers to treat patients with TRD.

Still image of a doctor at a desk
play-button

These healthcare providers have been compensated by Janssen Pharmaceuticals, Inc. for their participation in the video.

Reference:

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

next-background

Next:

Find Out What You Need to Consider