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SPRAVATO® REMS | SPRAVATO® (esketamine) HCP

Starting Patients & SPRAVATO® REMS

SPRAVATO® REMS1

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.

REMS in orange circle

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.

elipse two retina
REMS in purple circle

To see REMS requirements, click here

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.

Healthcare facility orange icon

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
Healthcare facility orange icon

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 (Monday – Friday, 8 AM to 8 PM ET).

For additional information, please see full Prescribing Information.

Reference:

1.SPRAVATO® [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. July 2020.