Prolia® (denosumab)
Product License No. 000918
Treatment of postmenopausal women with osteoporosis at high risk for fracture.
Explanation:
For postmenopausal women with osteoporosis in any one of the following situations:
- those patients with a history of osteoporotic fracture, or multiple risk factors for fracture;
- or those who have failed or are intolerant to other available osteoporosis therapies.
In postmenopausal women with osteoporosis, Prolia
® reduces the incidence of vertebral, non-vertebral, and hip fractures.
Treatment to increase bone mass in men with osteoporosis at high risk for fracture.
Explanation:
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.
Explanation:
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 at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer.
Explanation:
Prolia® also reduced the incidence of vertebral fractures for these patients.
Prolia® Approved Package Insert
Prolia® Medication Guide