×

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.

Close

Prolia® is the only FDA-approved therapy for cancer treatment–induced bone loss (CTIBL) due to hormone ablation therapy (CTIBL-HALT).1

Safety: Prolia® safety and tolerability was evaluated in a pivotal trial in men with nonmetastatic prostate cancer at high risk for fracture receiving ADT over a 3-year period1

Prolia® has been studied in a clinical trial of 1468 men with prostate cancer on ADT.2 The overall incidence of adverse events was similar between Prolia® and placebo (approximately 87%, respectively).2

Adverse events (≥ 10% frequency in each treatment group)1

Prolia®
(n = 731)
Placebo
(n = 725)
Arthralgia
12.6%
11.0%
Back Pain
11.1%
10.2%
Constipation
10.0%
10.3%
  • Pain in extremity and musculoskeletal pain have also been reported in clinical trials1
  • The percentage of patients who withdrew from the study due to adverse events was 7.0% and 6.1% for the Prolia® and placebo groups, respectively1
  • The overall rates of serious adverse events between Prolia® and placebo were 34.6% and 30.6%, respectively1

Important Safety Information

Prolia® is contraindicated in patients with hypocalcemia, in women who are pregnant and in patients with a history of systemic hypersensitivity to any component of the product. Patients receiving Prolia® should not receive XGEVA®. Clinically significant hypersensitivity, hypocalcemia, osteonecrosis of the jaw, atypical femoral fractures, multiple vertebral fractures following the discontinuation of Prolia® treatment, serious infections, dermatologic adverse reactions, musculoskeletal pain, and suppression of bone turnover have been reported in patients receiving Prolia®. Prolia® may cause fetal harm. It is not known whether Prolia® is excreted in human milk.

Please see additional Important Safety Information below, as well as Prescribing Information.

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