The Food and Drug Administration is changing dispensing requirements for the drug clozapine, an atypical antipsychotic used to treat schizophrenia and schizoaffective disorder, and to treat suicidal behavior in individuals with the disorders.

To address “continuing safety concerns,” the FDA has “clarified and enhanced” prescribing information for clozapine to simplify how to monitor patients on the drug for a blood condition known as neutropenia and better manage treatment.

In doing so, the FDA approved a new, shared-risk evaluation and mitigation strategy (REMS), known as the Clozapine REMS Program.

According to MayoClinic.org, neutropenia is an abnormally low count of white blood cells called neutrophils. Neutrophils help the body fight off infections, particularly ones caused by bacteria and fungi. The website states that some drugs cause neutropenia by destroying neutrophils or damaging bone marrow. [1]

A low number of neutrophils put patients at risk of developing severe infections that they may have difficulty fighting off.

Going forward, neutropenia will be monitored only by the absolute neutrophil count (ANC), instead of alongside the white blood cell count. Patients will be able to continue taking clozapine with a lower ANC, and those with benign ethnic neutropenia who previously were not eligible for clozapine will now be able to take the drug.

The FDA also handed down fresh directives concerning when doctors should interrupt clozapine treatments.

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The shared clozapine REMS will replace the 6 existing clozapine registries that clozapine-makers maintain. Prescribers, pharmacies, and patients must enroll in the single, centralized REMS. [2]

“The revised prescribing information and the Clozapine REMS Program will improve monitoring and management of patients with severe neutropenia,” the FDA notes. “The shared REMS is also expected to reduce the burden and possible confusion related to having separate registries for individual clozapine medicines. The requirements to monitor, prescribe, dispense, and receive all clozapine medicines are now incorporated into the Clozapine REMS Program.”

As of October 12, healthcare providers who wish to prescribe clozapine to individuals with neutropenia will need to be certified in the program, which requires reviewing prescribing information for the drug, as well as a guide for providers. They will have to pass an assessment and submit an enrollment form in order to continue prescribing the antipsychotic. Prescribers must also train their staff in the changes. [3]

Healthcare providers who treat individuals with neutropenia on an outpatient-basis must report their ANCs to the Clozapine REMS Program before clozapine can be dispensed. Patients that are inpatient must have their ANC reported within 7 days of their most recent blood sample.

The FDA says that the centralized REMS program will allow physicians the “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.”

Additional Sources:

[1] MayoClinic

[2] PharmacyTimes

[3] Medscape


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Post written byJulie Fidler:
Julie Fidler is a freelance writer, legal blogger, and the author of Adventures in Holy Matrimony: For Better or the Absolute Worst. She lives in Pennsylvania with her husband and two ridiculously spoiled cats. She occasionally pontificates on her blog.