For general population patients, i.e., those without benign ethnic neutropenia (BEN), interrupt treatment if neutropenia is suspected to be clozapine-induced for ANC less than 1,000 cells per microliter. For patients with BEN, interrupt treatment if neutropenia is suspected to be clozapine-induced for ANC less than 500 cells per microliter.

Although re-challenging patients who develop severe neutropenia during treatment with clozapine is not recommended, under the revised prescribing information prescribers will have more flexibility to make individualized treatment decisions for their patients if they determine that the risk of psychiatric illness is greater than the risk of recurrent severe neutropenia.

The National Non-Rechallenge Master File (NNRMF) will be discontinued on October 12, 2015. Patients were listed in the NNRMF if they had a WBC less than 2,000 cells per microliter or an ANC less than 1,000 cells per microliter.


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All patients listed in the NNRMF will be automatically transferred to the Clozapine REMS Program and clearly identified.