Prolia® Denosumab, Preservative Free 60 mg / mL Injection 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

More Information

• SDS