What is the National Non-Rechallenge Masterfile

The National Non-Rechallenge Masterfile is the national database that identifies patients who meet the no-rechallenge criteria (WBC<2,000/mm³ or ANC<1,000/mm³). Such patients are at risk for developing agranulocytosis and should never be rechallenged with clozapine.

Teva Clozapine Patient Registry reports patients with a WBC<2,000/mm³ or ANC<1,000/mm³ to the Novartis Clozaril^® National Registry for posting to the National Non-Rechallenge Masterfile.

Teva Clozapine Patient Registry conducts rechallenge status checks by contacting the Novartis Clozaril^® Patient Registry in order to determine if a patient is listed in the National Non-Rechallenge Masterfile.

If the patient is listed in the National Non-Rechallenge Masterfile, Registry staff will notify the health care provider that the patient should not be re-exposed to clozapine.

If the patient is not listed, the patient may be eligible for clozapine treatment per prescribing guidelines

The following graphic illustrates the bi-directional communication between the Teva Clozapine Patient Registry and the National Non-Rechallenge Masterfile.

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