Prolia® Denosumab, Preservative Free 60 mg / mL Injection Prefilled Syringe 1 mL

Features

• Prolia® (denosumab) 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 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 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 All patients should receive calcium 1000 mg daily and at least 400 IU vitamin D daily Pre-existing hypocalcemia must be corrected prior to initiating Prolia® Administer 60 mg every 6 months as a subcutaneous injection in the upper arm
• upper thigh
• or abdomen Each 1 mL single-use prefilled syringe of Prolia contains 60 mg denosumab (60 mg/mL solution)
• 4.7% sorbitol
• 17 mM acetate
• 0.01% polysorbate 20
• Water for Injection (USP)
• and sodium hydroxide to a pH of 5.2 Store Prolia in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton Protect Prolia from direct light and heat