骨質疏鬆症 Osteoporosis
Treatment of postmenopausal women with osteoporosis at high risk for fracture
#仿單變更2021

Bone-Modifying Agent (Monoclonal Antibody)
Prolia binds to RANKL, a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. Prolia prevents RANKL from activating its receptor, RANK, on the surface of osteoclasts and their precursors. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function, and survival, thereby decreasing bone resorption and increasing bone mass and strength.

Bioavailability, SubQ: 62%
Elimination Half Life: 25.3- 28 days
Onset of action: Decreases markers of bone resorption by ~85% within 3 days; maximal reductions observed within 1 month
Duration: Markers of bone resorption return to baseline within 12 months of discontinuing therapy

Hypersensitivity to denosumab or any component of the formulation; pre-existing hypocalcemia; pregnancy

X

Excretion unknown/not recommended

Common:
back pain, pain in extremity, musculoskeletal pain, Diarrhea, Nausea, Vomiting, Headache, URI, hypercholesterolemia, and cystitis.
Serious:
Hypocalcemia (1.7% to 18%), Hypophosphatemia, Infectious disease, Aseptic necrosis of bone of jaw, Cancer

60 mg administered as a single subcutaneous injection once every 6 months. Inject in the upper arm, upper thigh, or abdomen.

Store Prolia in a refrigerator at 2-8°C in the original carton. Do not freeze.
Once removed from the refrigerator, Prolia must not be exposed to temperatures above 25°C and must be used within 14 days.