SPRAVATO® (esketamine) Nasal Spray

How it Works

SPRAVATO targets glutamate signaling (via NMDA receptor antagonism) and can produce rapid antidepressant effects for some patients. Doses are self-administered in the clinicusing single-use nasal spray devices under direct observation. After dosing, patients are monitored for sedation, dissociation, blood-pressure changes, and respiratory status for at least 2 hours before discharge. Driving or operating machinery is not allowed until the next day after a full night’s sleep. Spravato HCP+1FDA Access DataSpravato

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What to Expect at Our Clinic

1. Evaluation & eligibility: We confirm TRD criteria, review medical/psychiatric history, medications, and safety considerations.
2. REMS program: SPRAVATO is available only through the SPRAVATO REMS. We handle all enrollment and safety steps. spravatorems.com
3. Dosing schedule (typical TRD course):
   1. Weeks 1–4: Twice weekly (56 mg or 84 mg per session)
   2. Weeks 5–8: Once weekly
   3. Week 9 and after: Every 1–2 weeks as needed (maintenance)
      Your clinician adjusts dose/frequency based on response and tolerability. Spravato HCPJ&J Medical Connect
4. Observation: You’ll rest in a comfortable setting with continuous monitoring for ≥2 hours and a clinician will clear you before you leave. Arrange a ride home. Spravato HCP

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Who Might Benefit

• Adults with treatment-resistant depression who have not responded adequately to prior antidepressant trials (with or without psychotherapy)
• Adults with MDD and acute suicidal ideation or behavior (administered with an oral antidepressant) FDA Access Data

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Safety, Contraindications & Precautions

FDA-Listed Contraindications

SPRAVATO must not be used in patients with:

• Aneurysmal vascular disease (e.g., thoracic/abdominal aorta, intracranial, peripheral) or arteriovenous malformation
• History of intracerebral hemorrhage
• Hypersensitivity to esketamine/ketamine or any excipient FDA Access Data

Important Warnings & Monitoring

• Blood pressure increases: Check BP before and after dosing; use caution if baseline BP is elevated or if an increase would pose risk. Uncontrolled hypertension is not a labeled “contraindication,” but clinicians weigh risks/benefits and may defer until controlled. Janssen LabelsSpravato HCP
• Sedation & dissociation; rare respiratory depression: reason for in-clinic dosing and ≥2-hour monitoring. Spravato HCP
• Abuse/misuse potential: Schedule CIII; monitored use under REMS. spravatorems.com
• Psychiatric comorbidities: Use clinical judgment with conditions like bipolar disorder (mania risk) or psychosis—these are not formal contraindications in the label but require careful evaluation and coordination of care. FDA Access Data
• Do not drive or operate machinery until the next day after a full night’s sleep. Spravato+1

If your initial note listed “contraindicated in uncontrolled hypertension, bipolar disorder, and a history of any symptoms”: to stay medically accurate on your website, present uncontrolled hypertension and bipolar disorder as clinical cautions/eligibility considerations, not label contraindications. Keep aneurysm/AVM, history of intracerebral hemorrhage, and hypersensitivity as the true contraindications.