macokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of
Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Treatment Resistant Depression
14.2 Treatment-Resistant Depression – Long-term
Study
14.3 Effects on Driving
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information are notlisted.
-----------------------------------------------
FULL PRESCRIBING INFORMATION
WARNING: SEDATION; DISSOCIATION; ABUSE AND MISUSE; and SUICIDAL
THOUGHTS AND BEHAVIORS
Sedation
● Patients are at risk for sedation after administration of SPRAVATO [see Warnings andPrecautions (5.1)].
Dissociation
● Patients are at risk for dissociative or perceptual changes after administration ofSPRAVATO [see Warnings and Precautions (5.2)].
Because of the risks of sedation and dissociation, patients must be monitored for at least2 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 Warnings andPrecautions (5.1, 5.2)].
Abuse and Misuse
● SPRAVATO has the potential to be abused and misused. Consider the risks andbenefits of prescribing SPRAVATO prior to use in patients at higher risk of abuse.
Monitor patients for signs and symptoms of abuse and misuse [see Warnings andPrecautions (5.3)].
Because of the risks of serious adverse outcomes resulting from sedation, dissociation, andabuse and misuse, SPRAVATO is only available through a restricted program under aRisk eva luation and Mitigation Strategy (REMS) called the SPRAVATO REMS [seeWarnings and Precautions (5.4)].
Suicidal Thoughts and BehaviorsAntidepressants increased the risk of suicidal thoughts and behavior in pediatric andyoung adult patients in short-term studies. Closely monitor all antidepressant-treatedpatients for clinical worsening, and for emergence of suicidal thoughts and behaviors.
SPRAVATO is not approved in pediatric patients [see Warnings and Precautions (5.5)].
1 INDICATIONS AND USAGE
SPRAVATO™ is indicated, in conjunction with an oral antidepressant, for the treatment oftreatment-resistant depression (TRD) in adults [see Clinical Studies (14.1)].
Limitations of Use:SPRAVATO is not approved as an anesthetic agent. The safety and effectiveness ofSPRAVATO as an anesthetic agent have not been established.
2 DOSAGE AND ADMINISTRATION
2.1 Important Considerations Prior to Initiating and During TherapySPRAVATO must be administered under the direct supervision of a healthcare provider. Atreatment session consists of nasal administration of SPRAVATO and post-administrationobservation under supervision.
Blood Pressure Assessment Before and After Treatment
• Assess blood pressure prior to dosing with SPRAVATO [see Warnings and Precautions(5.6)].
• If baseline blood pressure is elevated (e.g., >140 mmHg systolic, >90 mmHg diastolic),consider the risks of short term increases in blood pressure and benefit of SPRAVATOtreatment in patients with TRD [see Warnings and Precautions (5.6)]. Do not administerSPRAVATO if an increase in blood pressure or intracranial pressure poses a serious risk[see Contraindications (4)].
• After dosing with SPRAVATO, reassess blood pressure at approximately 40 minutes (whichcorrespo |
