Prolia Denosumab Injection

1. Indications and Usage
Postmenopausal Osteoporosis: Increased bone mass and reduced risk of vertebral, hip, and non-vertebral fractures in postmenopausal women at high risk for fracture.
Bone Metastases: To delay or decrease the risk of skeletal-related events (pathological fracture, spinal cord compression, irradiation or surgery to bone) in patients with bone metastases from solid tumors.
Giant Cell Tumor of Bone: Treatment of adult and skeletally mature adolescent patients with giant cell tumor of bone that is surgically resectable but would result in severe morbidity, or whose surgical resection is likely to result in severe morbidity, or in whom surgery is not an option.
2. Dosage and Administration
Osteoporosis: 60 mg administered by subcutaneous injection once every 6 months.
Bone Metastases: 120 mg administered by subcutaneous injection once every 4 weeks.
Giant Cell Tumor of Bone: 120 mg administered once every 4 weeks. In the first month, two additional 120 mg doses are given on day 8 and day 15.
Administration: Administered subcutaneously in the upper arm, thigh, or abdomen. Do not administer intravenously or intramuscularly.
3. Mechanism of Action
Denosumab is a human monoclonal antibody that binds with high specificity to receptor activator of nuclear factor-kappa B ligand (RANKL). By binding to RANKL, denosumab inhibits RANKL from binding to its receptor, RANK, on the surface of osteoclast progenitor cells. This inhibits the differentiation, function, and survival of osteoclasts, thereby decreasing bone resorption and increasing bone mass.
4. Safety and Warnings
Hypocalcemia: Severe hypocalcemia may occur, especially in patients with severe renal impairment. Pre-existing hypocalcemia must be corrected before initiation.
Osteonecrosis of the Jaw: Occurs rarely in patients treated with denosumab. A dental examination with appropriate preventive dentistry is recommended prior to treatment.
Severe Infections: Serious infections such as skin infections, abdominal infections, and otitis media have been reported.
Multiple Vertebral Fractures: Multiple vertebral fractures have been reported following discontinuation of denosumab for osteoporosis.
Atypical Fractures: Atypical femoral shaft fractures have been reported with anti-resorptive therapies.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: Back pain, arthralgia, musculoskeletal pain, hypercholesterolemia, extremity pain, and skin reactions.
Clinical Research: Clinical trials have demonstrated significant increases in bone mineral density and substantial reductions in fracture risk in postmenopausal osteoporosis patients.
6. Drug Interactions
Calcium and Vitamin D: Concomitant use is recommended to prevent hypocalcemia.
Other Anti-resorptive Agents: Concomitant use with oral bisphosphonates is not recommended.
Immunosuppressives: Theoretical risk of increased immunosuppression and infection risk.
7. Pharmaceutical Information
Composition: Denosumab, sodium acetate, acetic acid, polysorbate 20, sucrose, and water for injection.
Appearance: Clear to slightly opalescent, colorless to pale yellow solution.
Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light.