- Certify & Establish
- Treating Patients
- Education & Resources
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.
SPRAVATO® is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist indicated, in conjunction with an oral antidepressant, for the treatment of1:
Limitations of Use:
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.
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.
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
Outpatient healthcare settings
LEARN MORE ABOUT THE SPRAVATO® REMS CERTIFICATION PROCESS ON THE REMS WEBSITE.
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.
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