FDA label
What is Prolia used for?
Prolia contains denosumab. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for Prolia lists 5 uses: Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture; Treatment to Increase Bone Mass in Men with Osteoporosis; Treatment of Glucocorticoid-Induced Osteoporosis; Treatment of Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer; and 1 more.
Run it in Rivvi
Which 2027 plans near you dropped or restricted Prolia?
Tier changes and new prior auth, step therapy or quantity limits, plan by plan.
Free to start. Opens Rivvi, the AI workspace for healthcare teams.
Prolia, injection
Indications and Usage, quoted from the label by Amgen, Inc (BLA125320). Cross-references to other label sections are left out.
Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture
Prolia 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, Prolia reduces the incidence of vertebral, nonvertebral, and hip fractures.
Treatment to Increase Bone Mass in Men with Osteoporosis
Prolia 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.
Treatment of Glucocorticoid-Induced Osteoporosis
Prolia 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.
Treatment of Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer
Prolia 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 Prolia also reduced the incidence of vertebral fractures.
Treatment of Bone Loss in Women Receiving Adjuvant Aromatase Inhibitor Therapy for Breast Cancer
Prolia is indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
Source: DailyMed label, set id 49e5afe9-a0c7-40c4-af9f-f287a80c5c88, version 186, effective June 26, 2026. NDC 55513-710, one of 1 listing for this product.
Questions
What is Prolia used for?
The FDA label for Prolia lists 5 uses: Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture; Treatment to Increase Bone Mass in Men with Osteoporosis; Treatment of Glucocorticoid-Induced Osteoporosis; Treatment of Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer; and 1 more.
What drug class is Prolia?
FDA lists denosumab in the RANK Ligand Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.