Prescribing Information Medication Guide Register Log In Home Healthcare Settings Pharmacies Patients Contact Us Resources SPRAVATO™ REMS (Risk Evaluation and Mitigation Strategy) What is the SPRAVATO™ REMS (Risk Evaluation and Mitigation Strategy)? A REMS (Risk Evaluation and Mitigation Strategy) is a program required by the Food and Drug Administration (FDA) to manage known or potential serious risks associated with a drug product. The goal of the REMS is to mitigate the risks of serious adverse outcomes resulting from sedation and dissociation caused by SPRAVATO™ administration, and abuse and misuse of SPRAVATO™ by: Ensuring that SPRAVATO™ is only dispensed to and administered in medically supervised healthcare setting that provides patient monitoring Ensuring that pharmacies and healthcare settings that dispense SPRAVATO™ are certified Ensuring that each patient is informed about serious adverse outcomes from dissociation and sedation and need for monitoring Enrollment of all patients in the REMS (registry) to further characterize the risks and support safe use 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 Healthcare Settings must be certified in the SPRAVATO™ REMS in order to treat patients with SPRAVATO™ Healthcare Setting Certification Pharmacy Pharmacies must be certified in the SPRAVATO™ REMS in order to dispense SPRAVATO™ Pharmacy Certification Patient Patients must be enrolled in the SPRAVATO™ REMS in order to receive SPRAVATO™ treatment Patient Enrollment SPRAVATO™ Indication SPRAVATO™ is a non-competitive N-methyl D-aspartate (NMDA) receptor antagonist indicated, in conjuction with an oral antidepressant, for the treatment for treatment-resistant depression (TRD) in adults. SPRAVATO™ is only available through select distribution channels. If you have any questions about the SPRAVATO™ REMS or need help with certification or enrollment, call 1-855-382-6022 Monday – Friday 8AM – 8PM ET For SPRAVATO™ REMS Program information contact: Phone: 1-855-382-6022 Fax: 1-877-778-0091 Legal Terms of Use Privacy Policy Healthcare providers should report suspected adverse events or product quality complaints associated with SPRAVATO™ to Janssen at 1-800-JANSSEN (1-800-526-7736) or the FDA at 1-800-FDA-1088 or online at www.fda.gov/medwatch. This site is published by Janssen Pharmaceuticals Inc., which is solely responsible for its contents. This site is intended for use by healthcare professionals in the United States and Puerto Rico. Janssen Pharmaceuticals, Inc. recognizes that the internet is a global communications medium; however, laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. The Prescribing Information included here may not be appropriate for use outside the United States and Puerto Rico. Third party trademarks used herein are trademarks of their respective owners. Distributed by: Janssen Pharmaceuticals, Inc, Titusville, NJ 08560 ©Janssen Pharmaceuticals, Inc. 2019 03/2019 cp-80046v1