藥物警訊

Clozapine: Drug Safety Communication - FDA Modifies Monitoring for Neutropenia; Approves New Shared REMS Program

AUDIENCE: Psychiatry, Pharmacy, Hematology

ISSUE: FDA is making changes to the requirements for monitoring, prescribing, dispensing, and receiving the schizophrenia medicine clozapine, to address continuing safety concerns and current knowledge about a serious blood condition called severe neutropenia. Severe neutropenia is a dangerously low number of neutrophils, white blood cells that help fight infections. Severe neutropenia can be life-threatening.

There are two parts to the changes in the requirements for treating patients with clozapine. First, FDA clarified and enhanced the prescribing information for clozapine that explains how to monitor patients for neutropenia and manage clozapine treatment. Second, FDA approved a new, shared risk evaluation and mitigation strategy (REMS) called the Clozapine REMS Program. The revised prescribing information and the Clozapine REMS Program will improve monitoring and management of patients with severe neutropenia. 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.

BACKGROUND: Clozapine is an antipsychotic medicine used to treat schizophrenia in patients whose symptoms are not controlled with standard antipsychotic treatment. It is also used to treat recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder.

RECOMMENDATION: Patients who are currently treated with clozapine will be automatically transferred to the Clozapine REMS Program. In order to prescribe and dispense clozapine, prescribers and pharmacies will be required to be certified in the Clozapine REMS Program according to a specific transition schedule starting October 12, 2015.

Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

因精神分裂症用藥clozapine近期之嗜中性白血球低下症副作用，為了加強用藥安全，美國FDA擬修訂相關用藥規定。

此次增修之用藥規定分為兩部分，美國FDA以期能藉此改善對於病人發生嚴重嗜中性白血球低下症的監測與處置：

1. 於藥品處方資訊中再詳述應如何觀察病人是否發生嗜中性白血球低下症與如何執行治療。
2. 執行clozapine之風險評估暨管控計畫(Clozapine REMS Program)。此藥品之監測、處方、調劑、給藥的規定皆應納入REMS。

Clozapine為抗精神病用藥，用於治療接受標準治療無效之精神分裂症，也可用於精神分裂症或分裂情感障礙症病人之復發型自殺行為。

目前正在使用clozapine治療之病人將納入clozapine REMS計畫，相關開方者及藥局將於2015年10月12日起陸續進行REMS計畫認證。

相關訊息與連結請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
[Posted 09/16/2015]

資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部