REMS REGISTRY REQUIRED
Clozapine Monitoring Schedule
FDA REMS Program - ANC Monitoring Guidelines
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-- Select Phase --
Initiation Phase (First 6 Months)
Maintenance Phase (6-12 Months)
Extended Phase (After 12 Months)
Treatment Interruption Protocol
Re-Challenge After ANC Drop
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⚠ REMS REQUIREMENTS:
ANC must be ≥1500/µL to initiate (general population)
ANC must be ≥1000/µL for benign ethnic neutropenia (BEN)
Prescribers, pharmacies, and patients MUST be registered with Clozapine REMS
ANC monitoring is MANDATORY - do not miss monitoring windows
Report ANC results to REMS before next prescription can be dispensed