SPRAVATO™ is a non-competitive N-methyl D-aspartate (NMDA) receptor antagonist indicated, in conjunction with an oral antidepressant, for the treatment of treatment-resistant depression (TRD) in adults
What is a Certified SPRAVATO™ Treatment Center?
SPRAVATO™ is only administered in a medically supervised healthcare setting that is certified under the SPRAVATO™ REMS.
SPRAVATO™ is a nasal spray that is administered under the supervision of a healthcare professional. Certified SPRAVATO™ treatment centers will need to provide the infrastructure and operational support to prepare and monitor patients during self-administration and prior to release from the treatment center.
If you are interested in establishing your practice as a treatment center for SPRAVATO™, you must enroll in the SPRAVATO™ REMS and become certified.
SPRAVATO™ Risk Evaluation and Mitigation Strategy (REMS)
Why Does SPRAVATO™ Have A REMS?
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 and administered to patients in a medically supervised healthcare setting that monitors these patients
- Ensuring pharmacies and healthcare settings that dispense SPRAVATO™ are certified
- Ensuring that each patient is informed about the serious adverse outcomes resulting from sedation and dissociation 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 after SPRAVATO™ administration. SPRAVATO™ must never be dispensed directly to a patient for home use.
What are the REMS Requirements?
1. Healthcare setting certification
Healthcare settings must be certified in the REMS in order to treat patients with SPRAVATO™
2. Pharmacy certification
Pharmacies must be certified in the REMS in order to order and dispense SPRAVATO™. SPRAVATO™ should not be dispensed directly to the patient
3. Patient enrollment by HCP
Patients must be enrolled in the REMS in order to receive SPRAVATO™ treatment
To get started or find more information on how to certify your Healthcare Setting and/or Pharmacy, and enroll your patients to receive SPRAVATO™ treatment,
visit www.SPRAVATOrems.com or call 1-855-382-6022
How to Become a Certified SPRAVATO™ Treatment Center
Janssen has developed a SPRAVATO™ clinical education and training resource to support healthcare professionals within your healthcare setting in learning about the proper administration, monitoring requirements, and management of SPRAVATO™
To find more about information about how to certify your healthcare setting and/or Pharmacy, and enroll your patients to receive SPRAVATO™ treatment, visit www.SPRAVATOrems.com or call 1-855-382-6022
Locate a Certified SPRAVATO™ Treatment Center
Once a patient is ready to begin treatment, you or your patient can locate a certified SPRAVATO™ treatment center by clicking here.