Please be aware that starting on October 12, 2015, all clozapine products will be available only under a single shared Risk Evaluation and Mitigation Strategy (REMS) program. If you need additional information, limited resources can be found at www.clozapinerems.com.
The Clozapine, USP Orally Disintegrating Tablet (ODT) Patient Registry is part of a systematic active post-marketing surveillance program mandated by the United States Food and Drug Administration. Pursuant to this mandate, Jazz Pharmaceuticals plc is required to collect laboratory data, patient identification information and investigate adverse events associated with Clozapine, USP ODT.
The Patient Registry
Provides a database for WBC and absolute neutrophil count monitoring of patients treated with Clozapine, USP ODT to permit early detection of clozapine-induced leukopenia.
Provides confidential registration and report process for patients treated with Clozapine, USP ODT.
Provides ongoing updating of the Clozapine National Non-Rechallenge Masterfile with patients treated with Clozapine, USP ODT who become non-rechallengeable.
The Clozapine, USP ODT Patient Registry under the direction of the Clozapine, USP ODT Patient Registry Coordinating Center, includes a registry team, a professional toll-free call center at 1-877-329-2256, and a registry web-site.
The Clozapine, USP ODT Patient Registry team is composed of dedicated healthcare, registry, call center, administrative support and data management professionals.
The Clozapine, USP ODT Patient Registry Call Center is available 24 hours a day and 365 days a year to support all registry operations. Health care practitioners, pharmacist and patients may contact the call center with any questions related to the Clozapine, USP ODT Patient Registry. Health care practitioners and pharmacists may request registry materials directly through the call center.
Adverse Event Reporting
To report an adverse event please call 1-877-329-2256
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088