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Prolia

Prolia Indications/Uses

denosumab

Manufacturer:

Amgen

Distributor:

Zuellig
Full Prescribing Info
Indications/Uses
Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture: Denosumab (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, denosumab (Prolia) reduces the incidence of vertebral, nonvertebral, and hip fractures [see Pharmacology: Pharmacodynamics: Clinical Studies: Postmenopausal Women with Osteoporosis under Actions].
Treatment to Increase Bone Mass in Men with Osteoporosis: Denosumab (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 [see Pharmacology: Pharmacodynamics: Clinical Studies: Treatment to Increase Bone Mass in Men with Osteoporosis under Actions].
Treatment of Glucocorticoid-Induced Osteoporosis: Denosumab (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 [see Pharmacology: Pharmacodynamics: Clinical Studies: Treatment of Glucocorticoid-Induced Osteoporosis under Actions].
Treatment of Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer: Denosumab (Prolia) is indicated as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. In these patients denosumab (Prolia) also reduced the incidence of vertebral fractures [see Pharmacology: Pharmacodynamics: Clinical Studies: Treatment of Bone Loss in Men with Prostate Cancer under Actions].
Treatment of Bone Loss in Women Receiving Adjuvant Aromatase Inhibitor Therapy for Breast Cancer: Denosumab (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 [see Pharmacology: Pharmacodynamics: Clinical Studies: Treatment of Bone Loss in Women with Breast Cancer under Actions].
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