What is the Clozapine REMS?

The Clozapine REMS (Risk Evaluation and Mitigation Strategy) is a safety program required by the Food and Drug Administration (FDA) to manage the risk of severe neutropenia associated with clozapine treatment.

Severe neutropenia (absolute neutrophil count (ANC) less than 500/µL), can lead to serious and fatal infections.
Patient Information
To receive treatment, a patient must be enrolled in the Clozapine REMS program by a certified doctor.
Enrollment Information
Pharmacy
Pharmacies must be certified in the Clozapine REMS to receive and dispense clozapine.

If you are the designated authorized representative of a pharmacy, you can certify below.

Certify Pharmacy
Prescriber
Healthcare Providers must be certified in the Clozapine REMS to prescribe clozapine for outpatient use.

If you are a clozapine prescriber, you can certify below.

Certify Prescriber