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

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