PROLIA- denosumab injection

Amgen USA Inc.

Prolia is a RANK ligand (RANKL) inhibitor indicated for treatment:

• of postmenopausal women with osteoporosis at high risk for fracture (1.1)
• to increase bone mass in men with osteoporosis at high risk for fracture (1.2)
• of glucocorticoid-induced osteoporosis in men and women at high risk for fracture (1.3)
• to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer (1.4)
• to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer (1.5)

Store Prolia in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton. Do not freeze. Prior to administration, Prolia may be allowed to reach room temperature (up to 25°C/77°F) in the original container. Once removed from the refrigerator, Prolia must not be exposed to temperatures above 25°C/77°F and must be used within 14 days. If not used within the 14 days, Prolia should be discarded. Do not use Prolia after the expiry date printed on the label. Protect Prolia from direct light and heat.

Avoid vigorous shaking of Prolia.