Clozapine REMS program changes monitoring, dispensing regsFDAhas announced new REMS requirements for clozapine, an atypical antipsychotic for treatment-resistant schizophrenia, noting continued risk of severe neutropenia.J. Talsma
Clozapineis a medication used forschizophreniathatcan causesevere neutropenia (abnormally low number of white blood cells). Neutrophils (a type of white blood cell) are a part of the immune system that protects us from unwanted invaders like bacteria and viruses. When the number of neutrophils is...
Dr Mathis:The new sharedclozapineREMS program has similar components to the previous registries in that prescribers, pharmacies, and patients must be enrolled to prescribe, dispense, or receive clozapine. Prescribers and pharmacists are still required to check a patient's ANC on the basis of the ...
(REMS) program. The REMS was implemented to protect patients from clozapine-induced neutropenia, a condition that is treatable, wholly reversible, and unlikely to be fatal. Almost all cases occur during the first 4 months of initiating treatment. The risk of occurrence is less than 1% (about ...
Due to ongoing implementation challenges with the new Clozapine Risk Evaluation and Mitigation Strategy (REMS) Program (see the December 2015 issue of The Update ), the Food and Drug Administration is extending the Nov. 23, 2015, prescriber certification deadline and the Dec. 14, 2015, pharmacy...
Once the website is working properly, the data are fully reconciled, and the automations for the outpatient pharmacy are implemented, we believe the new program will streamline some of the administrative aspects of prescribing and dispensing clozapine. ...