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1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the

1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SPRAVATO™ safely and effectively. See full prescribing information for SPRAVATO™. SPRAVATO™ (esketamine) nasal spray, CIII Initial U.S. Approval: 1970 (ketamine) WARNING: SEDATION; DISSOCIATION; ABUSE AND MISUSE; and SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. ● Risk for sedation and dissociation after administration. Monitor patients for at least two hours after administration. (5.1, 5.2) ● Potential for abuse and misuse. Consider the risks and benefits of prescribing SPRAVATO prior to using in patients at higher risk of abuse. Monitor patients for signs and symptoms of abuse and misuse. (5.3) ● SPRAVATO is only available through a restricted program called the SPRAVATO REMS. (5.4) ● Increased risk of suicidal thoughts and behaviors in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. SPRAVATO is not approved for use in pediatric patients. (5.5) -----------------------------INDICATIONS AND USAGE--------------------------- SPRAVATO™ is a non-competitive N-methyl D-aspartate (NMDA) receptor antagonist indicated, in conjunction with an oral antidepressant, for the treatment of treatment-resistant depression (TRD) in adults. (1) Limitations of Use: SPRAVATO is not approved as an anesthetic agent. The safety and effectiveness of SPRAVATO as an anesthetic agent have not been established. (1) ------------------------DOSAGE AND ADMINISTRATION----------------------- • Administer SPRAVATO intranasally under the supervision of a healthcare provider. (2.1) • Assess blood pressure prior to and after administration. (2.1) • Evidence of therapeutic benefit should be evaluated at the end of the induction phase to determine need for continued treatment. (2.2) • See Full Prescribing Information for recommended dosage during the induction and maintenance phases. (2.2) • See Full Prescribing Information for important administration instructions. (2.3) ----------------------DOSAGE FORMS AND STRENGTHS--------------------- Nasal Spray: 28 mg of esketamine per device. Each nasal spray device delivers two sprays containing a total of 28 mg of esketamine. (3) -----------------------------CONTRAINDICATIONS--------------------------------- • Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial and peripheral arterial vessels) or arteriovenous malformation. (4) • Intracerebral hemorrhage. (4) • Hypersensitivity to esketamine, ketamine, or any of the excipients. (4) -------------------------WARNINGS AND PRECAUTIONS---------------------- • Increases in Blood Pressure: Patients with cardiovascular and cerebrovascular conditions and risk factors may be at an increased risk of associated adverse effects. (5.6) • Cognitive Impairment: SPRAVATO may impair attention, judgment, thinking, reaction speed and motor skills. (5.7) • Impaired Ability to Drive and Operate Machinery: Do not drive or operate machinery until the next day after a restful sleep. (5.8) • Embryo-fetal Toxicity: May cause fetal harm. Consider pregnancy planning and prevention in females of reproductive potential. (5.10, 8.1, 8.3) ------------------------------ADVERSE REACTIONS------------------------------- The most commonly observed adverse reactions (incidence ≥5% and at least twice that of placebo plus oral antidepressant) were dissociation, dizziness, nausea, sedation, vertigo, hypoesthesia, anxiety, lethargy, blood pressure increased, vomiting, and feeling drunk. (6) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Pharmaceuticals, Inc. at 1-800-JANSSEN (1-800-526-7736) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. -----------------------USE IN SPECIFIC POPULATIONS------------------------ • Lactation: Breastfeeding not recommended. (8.2) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 03/2019 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: SEDATION; DISSOCIATION; ABUSE AND MISUSE; SUICIDAL THOUGHTS AND BEHAVIORS 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Important Considerations Prior to Initiating and During Therapy 2.2 Recommended Dosage 2.3 Administration Instructions 2.4 Post-Administration Observation 2.5 Missed Treatment Session(s) 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Sedation 5.2 Dissociation 5.3 Abuse and Misuse 5.4 SPRAVATO Risk Evaluation and Mitigation Strategy (REMS) 5.5 Suicidal Thoughts and Behaviors in Adolescents and Young Adults 5.6 Increase in Blood Pressure 5.7 Cognitive Impairment 5.8 Impaired Ability to Drive and Operate Machinery 5.9 Ulcerative or Interstitial Cystitis 5.10 Embryo-fetal Toxicity 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 7 DRUG INTERACTIONS 7.1 Central Nervous System Depressants 7.2 Psychostimulants 7.3 Monoamine Oxidase Inhibitors (MAOIs) 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.3 Females and Males of Reproductive Potential 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Hepatic Impairment 9 DRUG ABUSE AND DEPENDENCE 9.1 Controlled Substance 9.2 Abuse 9.3 Dependence 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 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 not listed. 2 3 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 and Precautions (5.1)]. Dissociation ● Patients are at risk for dissociative or perceptual changes after administration of SPRAVATO [see Warnings and Precautions (5.2)]. Because of the risks of sedation and dissociation, patients must be monitored for at least 2 hours at each treatment session, followed by an assessment to determine when the patient is considered clinically stable and ready to leave the healthcare setting [see Warnings and Precautions (5.1, 5.2)]. Abuse and Misuse ● SPRAVATO has the potential to be abused and misused. Consider the risks and benefits 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 and Precautions (5.3)]. Because of the risks of serious adverse outcomes resulting from sedation, dissociation, and abuse and misuse, SPRAVATO is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the SPRAVATO REMS [see Warnings and Precautions (5.4)]. Suicidal Thoughts and Behaviors Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients 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 of treatment-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 of SPRAVATO as an anesthetic agent have not been established. 4 2 DOSAGE AND ADMINISTRATION 2.1 Important Considerations Prior to Initiating and During Therapy SPRAVATO must be administered under the direct supervision of a healthcare provider. A treatment session consists of nasal administration of SPRAVATO and post-administration observation 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 SPRAVATO treatment in patients with TRD [see Warnings and Precautions (5.6)]. Do not administer SPRAVATO 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 (which corresponds with the Cmax) and subsequently as clinically warranted. • If blood pressure is decreasing and the patient appears clinically stable for at least two hours, the patient may be discharged at the end of the post-dose monitoring period; if not, continue to monitor [see Warnings and Precautions (5.6)]. Food and Liquid Intake Recommendations Prior to Administration Because some patients may experience nausea and vomiting after administration of SPRAVATO [see Adverse Reactions (6.1)], advise patients to avoid food for at least 2 hours before administration and to avoid drinking liquids at least 30 minutes prior to administration. Nasal Corticosteroid or Nasal Decongestant Patients who require a nasal corticosteroid or nasal decongestant on a dosing day should administer these medications at least 1 hour before SPRAVATO [see Clinical Pharmacology (12.3)]. 2.2 Recommended Dosage Administer SPRAVATO in conjunction with an oral antidepressant (AD). 5 The recommended dosage for SPRAVATO is shown in Table 1. Dosage adjustments should be made based on efficacy and tolerability. Evidence of therapeutic benefit should be evaluated at the end of the induction phase to determine need for continued treatment. Table 1: Recommended Dosage for SPRAVATO Adults Induction Phase Weeks 1 to 4: Administer twice per week Day 1 starting dose: 56 mg Subsequent doses: 56 mg or 84 mg Maintenance Phase Weeks 5 to 8: Administer once weekly 56 mg or 84 mg Week 9 and after: Administer every 2 weeks or once weekly* 56 mg or 84 mg * Dosing frequency should be individualized to the least frequent dosing to maintain remission/response. 2.3 Administration Instructions SPRAVATO is for nasal use only. The nasal spray device delivers a total of 28 mg of esketamine. To prevent loss of medication, do not prime the device before use. Use 2 devices (for a 56 mg dose) or 3 devices (for an 84 mg dose), with a 5-minute rest between use of each device. Follow these administration instructions and read the Instructions for Use before administration: 6 7 8 9 a b c d uploads/Sante/ spravato-medication-guide.pdf