theModified Observer’s Alertness/Sedation scale (MOAA/s) [see Adverse Reactions (6.1)], and0.3% of SPRAVATO-treated patients experienced loss of consciousness (MOAA/s score of 0).
Because of the possibility of delayed or prolonged sedation, patients must be monitored by ahealthcare provider for at least 2 hours at each treatment session, followed by an assessment todetermine when the patient is considered clinically stable and ready to leave the healthcaresetting [see Dosage and Administration (2.4)].
Closely monitor for sedation with concomitant use of SPRAVATO with CNS depressants [seeDrug Interaction (7.1)].
SPRAVATO is available only through a restricted program under a REMS [see Warnings andPrecautions (5.4)].
5.2 Dissociation
The most common psychological effects of SPRAVATO were dissociative or perceptual changes(including distortion of time, space and illusions), derealization and depersonalization (61% to75% of SPRAVATO-treated patients developed dissociative or perceptual changes based on theClinician Administered Dissociative Symptoms Scale) [see Adverse Reactions (6.1)]. Given itspotential to induce dissociative effects, carefully assess patients with psychosis beforeadministering SPRAVATO; treatment should be initiated only if the benefit outweighs the risk.
Because of the risks of dissociation, patients must be monitored by a healthcare provider for atleast 2 hours at each treatment session, followed by an assessment to determine when the patientis considered clinically stable and ready to leave the healthcare setting [see Dosage andAdministration (2.4)].
SPRAVATO is available only through a restricted program under a REMS [see Warnings andPrecautions (5.4)].
5.3 Abuse and Misuse
SPRAVATO contains esketamine, a Schedule III controlled substance (CIII), and may be subjectto abuse and diversion. Assess each patient’s risk for abuse or misuse prior to prescribingSPRAVATO and monitor all patients receiving SPRAVATO for the development of thesebehaviors or conditions, including drug-seeking behavior, while on therapy. Contact local stateprofessional licensing board or state-controlled substances authority for information on how to prevent and detect abuse or diversion of SPRAVATO. Individuals with a history of drug abuseor dependence are at greater risk; therefore, use careful consideration prior to treatment ofindividuals with a history of substance use disorder and monitor for signs of abuse ordependence. [see Drug Abuse and Dependence (9)].
SPRAVATO is available only through a restricted program under a REMS [see Warnings andPrecautions (5.4)].
5.4 SPRAVATO Risk eva luation and Mitigation Strategy (REMS)SPRAVATO is available only through a restricted program under a REMS called theSPRAVATO REMS because of the risks of serious adverse outcomes from sedation,dissociation, and abuse and misuse [see Boxed Warning and Warnings and Precautions (5.1, 5.2,5.3)].
Important requirements of the SPRAVATO REMS include the following:
• Healthcare settings must be certified in the program and ensure that SPRAVATO is:
− Only dispensed in healthcare settings and administered to patients who are enrolled in theprogram.
− Administered by patients under the direct observation of a healthcare provider and thatpatients are monitored by a healthcare provider for at least 2 hours after administration ofSPRAVATO [see Dosage and Administration (2.4)].
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