Prolia Bone Resorption Inhibitor Denosumab, Preservative Free 60 mg / mL Subcutaneous Injection Prefilled Syringe 1 mL , Amgen 55513071001
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Manufacturer # | 55513071001 |
Brand | Prolia® |
Manufacturer | Amgen Inc |
Application | Bone Resorption Inhibitor |
Container Type | Prefilled Syringe |
Dosage Form | Injection |
Generic Drug Code | 28656 |
Generic Drug Name | Denosumab, Preservative Free |
NDC Number | 55513-0710-01 |
Storage Requirements | Requires Refrigeration |
Strength | 60 mg / mL |
Type | Subcutaneous |
UNSPSC Code | 51182428 |
User | Adults |
Volume | 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