therapeutic benefit should be eva luated at the end of theinduction phase to determine need for continued treatment.
• See Full Prescribing Information for recommended dosage during theinduction and maintenance phases.
See Full Prescribing Information for important administration instructions.
DOSAGE FORMS AND STRENGTHS
Nasal Spray: 28 mg of esketamine per device. Each nasal spray devicedelivers two sprays containing a total of 28 mg of esketamine.
CONTRAINDICATIONS
• Aneurysmal vascular disease (including thoracic and abdominal aorta,intracranial and peripheral arterial vessels) or arteriovenous malformation.
• Intracerebral hemorrhage.
• Hypersensitivity to esketamine, ketamine, or any of the excipients.
WARNINGS AND PRECAUTIONS
• Increases in Blood Pressure: Patients with cardiovascular andcerebrovascular conditions and risk factors may be at an increased risk ofassociated adverse effects.
• Cognitive Impairment: SPRAVATO may impair attention, judgment,thinking, reaction speed and motor skills.
• Impaired Ability to Drive and Operate Machinery: Do not drive or operatemachinery until the next day after a restful sleep.
• Embryo-fetal Toxicity: May cause fetal harm. Consider pregnancyplanning and prevention in females of reproductive potential.
ADVERSE REACTIONS
The most commonly observed adverse reactions (incidence ≥5% and at leasttwice that of placebo plus oral antidepressant) were dissociation, dizziness,nausea, sedation, vertigo, hypoesthesia, anxiety, lethargy, blood pressureincreased, vomiting, and feeling drunk.
To report SUSPECTED ADVERSE REACTIONS, contact JanssenPharmaceuticals, Inc. at 1-800-JANSSEN (1-800-526-7736) or FDA at1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
• Lactation: Breastfeeding not recommended.
See 17 for PATIENT COUNSELING INFORMATION and Medication
Guide.
Revised: 03/2019
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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 eva luation 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 Phar |
