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Indications

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 Read More

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.

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.

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.

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 Prolia® also reduced the incidence of vertebral fractures.

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.

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In the ABCSG-18 study, the incidence of adverse events or serious adverse events in the Prolia® and placebo groups were similar1

All adverse events that occurred in more than 5% of all patients1

Adverse Events
Prolia® 60 mg
every 6 months
[n = 1709]
Placebo every
6 months
[n = 1690]
Musculoskeletal and
connective tissue
disorders
832 (49%)
801 (47%)
Arthralgia
435 (26%)
437 (26%)
Back pain
151 (9%)
145 (9%)
Bone pain
137 (8%)
110 (7%)
Pain in extremity
106 (6%)
85 (5%)
Vascular disorders
472 (28%)
394 (23%)
Hot flush
263 (15%)
230 (14%)
Hypertension
111 (7%)
93 (6%)
General disorders
and administration
site conditions
277 (16%)
244 (14%)
Fatigue
108 (6%)
98 (6%)
Atypical fracture
0
0
ONJ*
0
0
  • *During the trial period, all potential cases of osteonecrosis of the jaw (ONJ) were adjudicated by an independent international expert panel. Thirty-one dental problems were assessed, but none were determined to meet the diagnostic criteria of ONJ.1
  • Serious adverse events included musculoskeletal and connective tissue disorders (eg, osteoarthritis, intervertebral disc protrusion); injury, poisoning, and procedural complications (eg, meniscus injury); nervous system disorders (eg, carpal tunnel syndrome); eye disorders (eg, cataract); and endocrine disorders (eg, goiter)1

If you have a clinical inquiry or would like to report an adverse event related to Prolia®, please visit www.amgen.com.