How to Set Up a REMS-certified SPRAVATO® Treatment Center
Is Becoming a
SPRAVATO® Treatment Center
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.
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?
HEALTHCARE SETTING CERTIFICATION
All healthcare settings must be certified in the REMS in order to receive, dispense, and/or treat patients with SPRAVATO®.
All pharmacies must be certified in the REMS in order to receive and dispense SPRAVATO®.
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.
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
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.
These healthcare providers have been compensated by Janssen Pharmaceuticals, Inc. for their participation in the video.
1. SPRAVATO® [Prescribing Information].
Titusville, NJ: Janssen Pharmaceuticals, Inc. July 2020.