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
The US Food and Drug Administration (FDA) has approved modifications to its risk evaluation and mitigation strategy (REMS) program for the antipsychotic clozapine. Effective February 28, all prescribers of clozapine, as well as pharmacies dispensing the drug, must be certified in the clozapine REMS...
Because of this, people taking clozapine may be required to enroll in the Clozapine REMS Program. Before starting on clozapine, a healthcare provider will check your neutrophil count and medical history to make sure it’s appropriate to prescribe for you. Once on the medication, your provider ...
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. ...