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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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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 were evaluated in a pivotal trial in women with breast cancer and bone loss from AI therapy over a 2-year period2

The overall incidence of adverse events was similar between Prolia® and placebo (91% vs 90%, respectively).2

Adverse events (≥ 10% frequency in each treatment group)2

Prolia®
(n = 129)
Placebo
(n = 120)
Arthralgia
24.0%
25.0%
Pain in extremity
14.7%
11.7%
Back Pain
14.0%
12.5%
Fatigue
13.2%
14.2%
  • Musculoskeletal pain has also been reported in clinical trials1
  • The percentage of patients who withdrew from the study due to adverse events was 0.8% and 4.2% for the Prolia® and placebo groups, respectively1
  • The incidence of serious adverse events was 14.7% in the Prolia® group and 9.2% in the placebo group1

CTIBL-HALT=cancer treatment–induced bone loss due to hormone ablation therapy.

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.