- Class: Monoclonal antibody, RANKL inhibitor
- Mechanism of Action:
Denosumab is a fully human monoclonal antibody that binds to and inhibits RANKL (Receptor Activator of Nuclear factor Kappa-B Ligand), a key factor in osteoclast formation, function, and survival. By blocking RANKL, denosumab reduces bone resorption and increases bone density.
Indications
- Oncology uses:
- Prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors (e.g., breast cancer, prostate cancer, lung cancer).
- Treatment of giant cell tumor of bone.
- Prevention of bone loss and fractures in patients receiving hormone deprivation therapy for prostate or breast cancer.
- Hypercalcemia of malignancy refractory to bisphosphonates.
- Non-oncology uses:
- Treatment of osteoporosis (Prolia brand).
Dosage (Oncology indication)
- For prevention of SREs in bone metastases:
120 mg subcutaneously every 4 weeks. - Dose adjustments not generally required for renal impairment, but caution in severe renal impairment due to hypocalcemia risk.
Key Toxicities and Monitoring
- Common adverse effects:
- Hypocalcemia (monitor serum calcium, magnesium, phosphate before and during therapy)
- Osteonecrosis of the jaw (ONJ) — dental exam recommended before initiation
- Infections (skin infections reported)
- Fatigue
- Monitoring:
- Serum calcium and vitamin D levels at baseline and regularly.
- Dental health assessment.
- Monitor for signs of hypocalcemia (muscle cramps, spasms).
Drug Interactions
- No major interactions, but concurrent use with other bone-modifying agents should be monitored carefully.