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 indicated:

    • For the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, denosumab reduces the incidence of vertebral, nonvertebral, and hip fractures.
    • For treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.
    • For the treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 6 months. High risk of fracture is defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.
    • As a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy (ADT) for nonmetastatic prostate cancer. In these patients denosumab also reduced the incidence of vertebral fractures.
    • As a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor (AI) therapy for breast cancer.