FDA: Important Updates to the Clozapine REMS Program

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Products covered under the Clozapine REMS program include Clozaril (HLS Therapeutics), Fazaclo (Jazz), and Versacloz (TruPharma), in addition to all generic versions.

According to the Food and Drug Administration (FDA), prescribers and pharmacies must be certified in the Clozapine REMS program by February 28, 2019 in order to continue to prescribe or dispense clozapine.

Other modifications to the Clozapine REMS program, which was established to ensure that patients have continued access to the drug and that the associated risks are appropriately managed, include the following:

  • Inpatient prescribers are not required to be certified if they are prescribing for patients already enrolled in the program.
  • If a patient’s absolute neutrophil count (ANC) is not current, this will not prevent clozapine from being dispensed. Although not required, pharmacies are encouraged to contact the prescriber to acquire the most recent patient ANC information for patient safety purposes, if a current ANC is not on file.
  • Pharmacies are no longer allowed to enroll patients in the Clozapine REMS Program after February 28, 2019, since the enrollment of patients must be completed by the prescriber or the prescriber designee.

Clozapine is an atypical antipsychotic indicated for treatment-resistant schizophrenia and for reducing suicidal behavior in patients with schizophrenia or schizoaffective disorder. Because of the risk of severe neutropenia, the treatment is only available through a restricted program, known as the Clozapine REMS. Patients who receive clozapine must be enrolled in the program and comply with the ANC testing and monitoring requirements.

Products covered under the Clozapine REMS program include Clozaril (HLS Therapeutics), Fazaclo (Jazz), and Versacloz (TruPharma), in addition to all generic versions.

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For more information visit clozapinerems.com.