What is the Stoboclo® (denosumab-bmwo) 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 Stoboclo® (denosumab-bmwo) REMS is to inform healthcare providers and patients about the following serious risk of:
- Severe Hypocalcemia in Patients with Advanced Kidney Disease
The Stoboclo® (denosumab-bmwo) REMS program materials are designed to inform health providers and patients about this risk with Stoboclo® (denosumab-bmwo). The Stoboclo® 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.
To learn more about the serious risk of Stoboclo®, read the Important Safety Information provided in this link and use the links on the right to access REMS supporting materials.
Reporting Adverse Events
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. Healthcare providers should report all suspected adverse events associated with Stoboclo® to the FDA or to Celltrion USA at 1-800-560-9414.
MATERIALS FOR HEALTHCARE PROVIDERS
