This site is for U.S. residents only.

This site is for U.S. residents only.

BosayaTM (denosumab-kyqq) Risk Evaluation and Mitigation Strategy

What is the BOSAYA 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 BOSAYA REMS is to inform healthcare providers and patients about the following serious risk of:

  • Severe Hypocalcemia in Patients with Advanced Kidney Disease

The BOSAYA REMS program materials are designed to inform healthcare providers and patients about this risk with BOSAYA. The BOSAYA 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 BOSAYA 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 BOSAYA to the FDA or to call Biocon Biologics Inc. at 1-833-986-1468.

Materials for Healthcare Providers

REMS Letter for Healthcare Providers
Patient Guide
Prescribing Information

Materials for Patients

Patient Guide

Bosaya and the Bosaya Logo are trademarks of
Biocon Biologics Limited.
©2025 Biocon Biologics Inc. All rights reserved.

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Bosaya and the Bosaya Logo are trademarks of
Biocon Biologics Limited.
©2025 Biocon Biologics Inc. All rights reserved.

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Bosaya and the Bosaya Logo are trademarks of Biocon Biologics Limited.
©2025 Biocon Biologics Inc. All rights reserved.

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Bosaya and the Bosaya Logo are trademarks of Biocon Biologics Limited.
©2025 Biocon Biologics Inc. All rights reserved.

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INDICATIONS

BOSAYA (denosumab-kyqq) is a prescription medicine used to:

    • Treat osteoporosis (thinning and weakening of bone) in women after menopause who are at high risk for fracture or cannot use another osteoporosis medicine or other osteoporosis medicines did not work well.
    • Increase bone mass in men with osteoporosis who are at high risk for fracture.
    • Treat osteoporosis in men and women who will be taking corticosteroid medicines (such as prednisone) for at least 6 months and are at high risk for fracture.
    • Treat bone loss in men who are at high risk for fracture receiving certain treatments for prostate cancer that has not spread to other parts of the body.
    • Treat bone loss in women who are at high risk for fracture receiving certain treatments for breast cancer that has not spread to other parts of the body.

It is not known if BOSAYA is safe and effective in children. BOSAYA is not approved for use in children.