Denosumab-nxxpdrug info
1 ML denosumab-nxxp 60 MG/ML Prefilled Syringe [Bildyos]
What it is used for
Bildyos is a RANK ligand (RANKL) inhibitor indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture. to increase bone mass in men with osteoporosis at high risk for fracture. of glucocorticoid-induced osteoporosis in men and women at high risk for fracture. to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
1.1 Treatment of
Postmenopausal Women with Osteoporosis at High Risk for Fracture Bildyos 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.
1.2 Treatment to
Increase Bone Mass in Men with Osteoporosis Bildyos is indicated 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.
1.3 Treatment of
Glucocorticoid-Induced Osteoporosis Bildyos is indicated 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.
1.4 Treatment of
Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer Bildyos is indicated 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.
1.5 Treatment of
Bone Loss in Women Receiving Adjuvant Aromatase Inhibitor Therapy for Breast Cancer Bildyos is indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective August 18, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Denosumab-nxxp is a human IgG2 monoclonal antibody with affinity and specificity for human RANKL (receptor activator of nuclear factor kappa-B ligand). Denosumab-nxxp has an approximate molecular weight of 147 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Bildyos (denosumab-nxxp) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. Each 1 mL single-dose prefilled syringe of Bildyos contains 60 mg denosumab-nxxp (60 mg/mL solution), glacial acetic acid (1.02 mg), polysorbate 20 (0.1 mg), sorbitol (47.0 mg), Water for Injection (USP), and sodium hydroxide to a pH of 5.2.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective August 18, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
See what it costs — price without insurance