Versacloz™ Patient Registry Information

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General Overview

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Prescribing Information

                        Prescribing Information                    Download Adobe Acrobat

The Versacloz Patient Registry is a component of a Risk Evaluation and Mitigation Strategy (REMS) required by the United States Food and Drug Administration. Pursuant to this requirement, Jazz Pharmaceuticals Inc. is required to collect laboratory data, patient identification information and investigate adverse events associated with Versacloz.

The Versacloz Patient Registry:

Provides a database for WBC and absolute neutrophil count monitoring of patients treated with Versacloz to permit early detection of clozapine-induced leukopenia.

Provides confidential registration and report process for patients treated with Versacloz

Provides ongoing updating of the Clozapine National Non-Rechallenge Masterfile with patients treated with Versacloz who become non-rechallengeable.

The Versacloz Patient Registry, under the direction of the Versacloz 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 Versacloz Patient Registry team is composed of dedicated healthcare, registry, call center, administrative support and data management professionals.

The Versacloz 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 Versacloz 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.

 

You may contact the Versacloz Patient Registry at 1-877-329-2256 or at www.versaclozregistry.com.

Please see full Prescribing Information, including BOXED Warning, for additional important safety information.