PROLIA® (Non-English)

Prolia is administered as a subcutaneous injection given 60 mg every 6 months in the upper arm, upper thigh, or abdomen. It is used for the treatment of osteoporosis in postmenopausal women at increased risk of fractures. Prolia significantly reduces the risk of vertebral, non-vertebral, and hip fractures.

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

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

PROLIA is a liquid for injection, available in a prefilled syringe. Each pre-filled syringe contains 60 mg of denosumab in 1 ml of solution (60 mg/ml).

• Pregnancy must be ruled out prior to the administration of Prolia.
• Before initiating Prolia in patients with advanced chronic kidney disease, including dialysis patients, evaluate for the presence of chronic kidney disease mineral and bone disorder with intact parathyroid hormone, serum calcium, 25(OH) vitamin D, and 1,25(OH)2 vitamin D.
• PROLIA is administered as a single injection under the skin (subcutaneous) every 6 months. The injection can be in your upper arm, upper thigh, or abdomen.
• Prolia should be administered by a healthcare professional.
• It can be given any time with or without food by a healthcare professional, by a trained injector, or a patient may self-inject if a healthcare professional determines that is appropriate.
• Your prefilled syringe may be left outside the refrigerator to reach room temperature (up to 25C) before injection. This will make the injection more comfortable. See instructions for injection.

Contraindications

1. Hypocalcemia
2. Pregnancy
3. Known hypersensitivity to Prolia

After-care

• Instruct patients to take calcium 1000 mg daily and at least 400 IU vitamin D daily.