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  • SPRAVATO® REMS (Risk Evaluation and Mitigation Strategy)
    What is the SPRAVATO ® REMS (R isk E valuation and M itigation S trategy)? A 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 ® (esketamine) nasal spray CIII is available only through a restricted distribution program called the
  • SPRAVATO® REMS (Risk Evaluation and Mitigation Strategy)
    SPRAVATO ® REMS Healthcare Setting Enrollment Healthcare settings must be certified in the SPRAVATO ® REMS in order to prescribe product 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
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    SPRAVATO® REMS Program Overview (Risk Evaluation and Mitigation Strategy) This overview describes the SPRAVATO® REMS requirements and responsibilities of inpatient healthcare settings, outpatient healthcare settings, pharmacies, and patients
  • SPRAVATO® REMS (Risk Evaluation and Mitigation Strategy)
    What is the SPRAVATO ® REMS (R isk E valuation and M itigation S trategy)? Because of the risks associated with SPRAVATO ®, the Food and Drug Administration (FDA) has required a special program called a Risk Evaluation and Mitigation Strategy (REMS) As part of the REMS, your healthcare provider will discuss the risks of misuse, abuse, sedation (feeling sleepy), dissociation (feeling
  • SPRAVATO® REMS (Risk Evaluation and Mitigation Strategy)
    SPRAVATO ® REMS Inpatient Healthcare Setting Enrollment Inpatient Healthcare Settings must be certified in the SPRAVATO® REMS in order to treat patients with SPRAVATO® SPRAVATO® is intended for patient administration under the direct observation of a healthcare provider, due to risks of serious adverse outcomes resulting from sedation, dissociation, and respiratory depression caused by
  • SPRAVATO REMS Patient Enrollment Form - Outpatient Use Only
    SPRAVATO® REMS Patient Enrollment Form - Outpatient Use Only This section is to be completed by the Patient Your healthcare provider will help you complete this form and provide you with a copy * Indicates required field
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    Form for healthcare providers to monitor patients after SPRAVATO® administration, ensuring safety and compliance with REMS requirements
  • Outpatient Healthcare Setting Enrollment Form - SPRAVATO® REMS
    Have healthcare provider(s) and a pulse oximeter to monitor patients onsite Review the SPRAVATO® Prescribing Information and REMS Program Overview Enroll in the SPRAVATO® REMS by completing and submitting the Outpatient Healthcare Setting Enrollment Form Establish processes and procedures to: Enroll the patient in the SPRAVATO® REMS
  • SPRAVATO® REMS
    SPRAVATO® REMS Patient Monitoring Form - Outpatient Use Only INSTRUCTIONS: This form is intended only for use by outpatient medical ofices or clinics, excluding emergency departments





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