What is the blood pressure monitoring protocol for Spravato (esketamine) nasal spray?

Spravato Blood Pressure Monitoring Protocol

Blood pressure must be assessed before each Spravato dose, and patients must be monitored for at least 2 hours post-administration, with BP measurement around 40 minutes post-dose and subsequently as clinically warranted until values decline. 1

Pre-Dose Assessment

Do not administer Spravato if baseline BP is elevated (generally >140/90 mmHg) - delay therapy and weigh individual benefit-risk considerations before proceeding. 1

Absolute Contraindications for BP Concerns

Spravato is contraindicated in patients with:

• Aneurysmal vascular disease (thoracic/abdominal aorta, intracranial, peripheral arterial vessels)
• Arteriovenous malformation
• History of intracerebral hemorrhage 1

High-Risk Patients Requiring Careful Assessment

Before prescribing, carefully evaluate patients with:

• Other cardiovascular or cerebrovascular conditions
• History of hypertensive encephalopathy (requires more intensive monitoring with more frequent BP and symptom assessment)
• Concomitant use of psychostimulants or MAOIs (requires closer BP monitoring) 1

Post-Dose Monitoring Protocol

Timing and Duration

• Monitor for minimum 2 hours after administration 1, 2
• BP increases peak approximately 40 minutes post-dose 1, 3
• Effects typically last approximately 4 hours 1
• BP generally returns to pre-dose levels by 1.5 hours post-dose 3

Specific Monitoring Steps

1. Measure BP around 40 minutes post-dose (when peak elevation occurs) 1

2. Continue monitoring as clinically warranted until BP values decline to acceptable levels 1

3. Expected BP changes:

   • Mean maximum increases: 13.3/8.7 mmHg (esketamine) vs 6.1/4.9 mmHg (placebo) in adults 18-64 years
   • In elderly (≥65 years): 16.0/9.5 mmHg vs 11.1/6.8 mmHg 3
   • Approximately 3-19% of patients experience increases ≥40 mmHg systolic and/or ≥25 mmHg diastolic in first 1.5 hours during first 4 weeks 1

Management of Elevated BP

If BP remains high after monitoring:

• Promptly seek assistance from practitioners experienced in BP management 1

Hypertensive Crisis (chest pain, shortness of breath):

• Refer immediately for emergency care 1

Hypertensive Encephalopathy (sudden severe headache, visual disturbances, seizures, diminished consciousness, focal neurological deficits):

• Refer immediately for emergency care 1

Key Clinical Considerations

Dose-Related Effects

• BP increases are dose-dependent 4
• Substantial BP increase can occur after any dose, even if smaller effects were observed with previous administrations 1
• Elevations occur on each dosing day with multiple administration schedules 4

Safety Profile

The evidence demonstrates that BP elevations are generally:

• Transient (resolving within 2-4 hours) 4, 3
• Asymptomatic in most cases 4, 3
• Well-tolerated with <2% discontinuation due to BP-related adverse events 3

However, 14/70 patients (20%) in one study experienced treatment-emergent transient hypertension (SBP >180 mmHg and/or DBP >110 mmHg), reinforcing the critical importance of the 90-120 minute monitoring period. 5

Proper BP Measurement Technique

When measuring BP for Spravato monitoring, follow standardized technique 6:

• Patient seated with back supported, feet flat on floor
• 5 minutes of quiet rest before measurement
• Arm supported at heart level
• Use validated, calibrated device with appropriate cuff size
• No talking during measurement