BILDYOS (denosumab-nxxp) Risk Evaluation and Mitigation Strategy
What is the BILDYOS REMS?
A REMS (Risk Evaluation and Mitigation Strategy) is a program required by the Food and Drug Administration to manage known or potential serious risks associated with a drug product.
The purpose of the BILDYOS REMS is to inform healthcare providers and patients about the following serious risk of:
- Severe Hypocalcemia in Patients with Advanced Kidney Disease.
The BILDYOS REMS program materials are designed to inform healthcare providers and patients about this risk with BILDYOS. The BILDYOS REMS program materials include a REMS Letter for Healthcare Providers and a Patient Guide. It is important that you discuss with each patient the information included in the Patient Guide.
Materials for Healthcare Providers
Materials for Patients
To learn more about the serious risk of BILDYOS, read the Important Safety Information provided in this link and use the links on this webpage to access REMS supporting materials.
Reporting Adverse Events
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1-800-FDA-1088. Healthcare providers should report all suspected adverse events associated with BILDYOS to the FDA or to Organon at 1-844-674-3200.
Materials for Healthcare Providers
Materials for Patients