What is the Jubbonti REMS?
The Jubbonti REMS (Risk Evaluation and Mitigation Strategy) is a safety program required by the Food and Drug Administration. The purpose of the Jubbonti REMS is to inform healthcare providers and patients about the risk of severe hypocalcemia in patients with advanced chronic kidney disease, including dialysis-dependent patients, following Jubbonti administration.
The Jubbonti REMS materials are designed to inform healthcare providers and their patients about the risk of severe hypocalcemia associated with Jubbonti and include the below materials. It is important that you discuss with your patients the information included in the Patient Guide.
Resources
For Healthcare Providers
For Patients
To learn more about Jubbonti, read the Important Safety Information and use the links to access the Jubbonti REMS materials.
Reporting Adverse Events
To report Adverse Reactions with Jubbonti, please call Sandoz Inc. at 1-800-525-8747, or report the event at FDA MedWatch.