REMS (Risk Evaluation and Mitigation Strategy)
Prolia® (denosumab) 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 Prolia® REMS is to inform healthcare providers and patients about the following serious risk of:
Severe Hypocalcemia in Patients with Advanced Kidney Disease
The Prolia® REMS program materials are designed to inform healthcare providers and patients about this risk with Prolia®. The Prolia® 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
REMS Letter for Healthcare Providers
Patient Guide
Prescribing Information
Materials for Patients
CONEXXENCE (denosumab-bnht) REMS
CONEXXENCE (denosumab-bnht) is biosimilar to PROLIA® (denosumab).
The CONEXXENCE REMS (Risk Evaluation and Mitigation Strategy) is a safety program required by the Food and Drug Administration.
Severe Hypocalcemia in Patients with Advanced Kidney Disease
Patients with advanced chronic kidney disease (eGFR < 30 mL/min/1.73 m2), including dialysis-dependent patients, are at greater risk of severe hypocalcemia following CONEXXENCE administration.
Severe hypocalcemia resulting in hospitalization, life-threatening events and fatal cases have been reported.
To minimize the risk of hypocalcemia in patients with advanced chronic kidney disease (CKD):
Evaluate for the presence of chronic kidney disease-mineral bone disorder (CKD-MBD) with intact parathyroid hormone (iPTH), serum calcium, 25(OH) vitamin D, and 1,25(OH)2 vitamin D prior to decisions regarding CONEXXENCE treatment.
Consider assessing bone turnover status (serum markers of bone turnover or bone biopsy) to evaluate the underlying bone disease that may be present.
Monitor serum calcium weekly for the first month after CONEXXENCE administration and monthly thereafter.
Coordinate care with healthcare providers with expertise in CKD-MBD for patients with advanced chronic kidney disease.
Role of the Healthcare Provider
Provide each patient with a copy of the Patient Guide.
Review information in the Patient Guide with each patient, including the serious risk of CONEXXENCE and the symptoms of severe hypocalcemia.
Advise each patient to seek prompt medical attention if they have signs or symptoms of severe hypocalcemia.
This letter does not contain the complete safety profile for CONEXXENCE. Please review the Prescribing Information enclosed. All CONEXXENCE REMS materials are also available at www.conexxencerems.com.
Reporting Adverse Events
To report Adverse Reactions with CONEXXENCE, please call Fresenius Kabi USA, LLC Vigilance at 1-800-551-7176, or report the event at FDA MedWatch.
BILDYOS (denosumab-nxxp) REMS
The FDA has required Shanghai Henlius Biotech, Inc. to distribute this safety update for the following serious risk of BILDYOS:
Severe Hypocalcemia in Patients with Advanced Kidney Disease
Patients with advanced chronic kidney disease (eGFR <30 mL/min/1.73 m2), including dialysis-dependent patients, are at greater risk of severe hypocalcemia following BILDYOS administration.
Severe hypocalcemia resulting in hospitalization, life-threatening events and fatal cases have been reported.
To minimize the risk of hypocalcemia in patients with advanced chronic kidney disease (CKD):
Evaluate for the presence of chronic kidney disease-mineral bone disorder (CKD-MBD) with intact parathyroid hormone (iPTH), serum calcium, 25(OH) vitamin D, and 1,25 (OH)2 vitamin D prior to decisions regarding BILDYOS treatment.
Consider assessing bone turnover status (serum markers of bone turnover or bone biopsy) to evaluate the underlying bone disease that may be present.
Monitor serum calcium weekly for the first month after BILDYOS administration and monthly thereafter.
Coordinate care with healthcare providers with expertise in CKD-MBD for patients with advanced chronic kidney disease.
Role of the Healthcare Provider
Provide each patient with a copy of the Patient Guide.
Review information in the Patient Guide with each patient, including the serious risk of BILDYOS and the symptoms of severe hypocalcemia.
Advise each patient to seek prompt medical attention if they have signs or symptoms of severe hypocalcemia.
This letter does not contain the complete safety profile of BILDYOS. Please review the Prescribing Information enclosed. All BILDYOS REMS materials are also available at (www.bildyos-rems.com) or by contacting your local Organon Sales Representative.
Reporting Adverse Events
To report Adverse Reactions with BILDYOS, please call representative of Shanghai Henlius Biotech, Inc. at 844674-3200, or report the event at FDA MedWatch.
Ospomyv (denosumab-dssb) REMS
The FDA has required Samsung Bioepis Co., Ltd. to distribute this safety notice to your organization as part of the Ospomyv REMS (Risk Evaluation and Mitigation Strategy). We request that you inform your members about the following serious risk of Ospomyv:
Severe Hypocalcemia in Patients with Advanced Kidney Disease
Patients with advanced chronic kidney disease (eGFR < 30 mL/min/1.73 m²), including dialysis-dependent patients, are at greater risk of severe hypocalcemia following Ospomyv administration.
Severe hypocalcemia resulting in hospitalization, life-threatening events and fatal cases have been reported.
To minimize the risk of hypocalcemia in patients with advanced chronic kidney disease (CKD):
Evaluate for the presence of CKD-MBD with intact parathyroid hormone (iPTH), serum calcium, 25(OH) vitamin D, and 1,25(OH)₂ vitamin D prior to decisions regarding Ospomyv treatment.
Consider assessing bone turnover status (serum markers of bone turnover or bone biopsy) to evaluate the underlying bone disease that may be present.
Monitor serum calcium weekly for the first month after Ospomyv administration and monthly thereafter.
Coordinate care with healthcare providers with expertise in CKD-MBD for patients with advanced chronic kidney disease.
Role of the Healthcare Provider
Provide each patient a copy of the Patient Guide.
Review information in the Patient Guide with your patients, including the serious risks of Ospomyv and the symptoms of severe hypocalcemia.
Advise each patient to seek prompt medical attention if they have signs or symptoms of severe hypocalcemia.
This letter does not contain the complete safety profile for Ospomyv. Please review the Prescribing Information available at www.ospomyvrems.com. Prescribing Information is also accessible by scanning the QR code below with your mobile phone. All Ospomyv REMS materials are also available at www.ospomyvrems.com.
Reporting Adverse Events
To report Adverse Reactions with Ospomyv, please call Samsung Bioepis Co., Ltd’s designated point of contact at 1-833-267-3130, or report the event at FDA MedWatch