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denosumab

M05BX04

Forms & Strengths

60mg/ml solution for injection in a 1ml prefilled syringe
60mg/ml solution for injection in a 1.7ml prefilled syringe

Adult Dosing

60mg every 6 months for treatment of osteoporosis in postmenopausal women and in men
120mg plus 60mg on day 8 and 15 of treatment for giant cell tumor of bone
120mg every 4 weeks with 2mg/kg zoledronic acid IV for hypercalcemia of malignancy
120mg every 7 days for 3 doses for bone metastases from solid tumors

Pediatric Dosing

0.9mg/kg every 4 weeks for giant cell tumor of bone in pediatric patients
Not recommended for pediatric patients with osteoporosis

Indications

Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures
Treatment of bone metastases from solid tumors
Treatment of giant cell tumor of bone
Treatment of hypercalcemia of malignancy

Mechanism of Action

Human monoclonal antibody that binds to and inhibits RANKL
RANKL inhibition reduces osteoclast formation, function and survival
Decreased bone resorption and increased bone density

Contraindications

Hypersensitivity to denosumab or to any of its excipients
Same class warnings for hypocalcemia and severe, prolonged hypocalcemia

Adverse Reactions

Hypocalcemia, hypophosphatemia
Increased risk of infection
Dermatologic reactions
Pancreatitis
Hypersensitivity reactions, anaphylaxis

Drug Interactions

Concomitant use with other denosumab products not recommended
Not recommended with bisphosphonates or other agents that lower bone density

Curated Content: Needs Vetting Before Put to Clinical Use