Denosumab(den os you mab)
Prolia, Xgeva
PREGNANCY CATEGORY D (XGEVA)
PREGNANCY CATEGORY X (PROLIA)
Drug Classes
Nuclear factor kappa B (RANK) ligand inhibitor
Therapeutic Actions
Human monoclonal antibody that prevents the activation of RANK ligand, a protein essential for the formation and function of osteoclasts, which are responsible for bone resorption. This action inhibits osteoclast formation and survival, decreasing bone resorption and increasing bone mass and strength.
Indications
Treatment of postmenopausal women and men with osteoporosis who are at high risk for fracture (history of osteoporotic fractures, failure on or intolerant to other osteoporosis therapy) (Prolia only)
Prevention of skeletal-related events in patients with bone metastases from solid tumors (Xgeva only).
Treatment of bone loss in breast cancer patients receiving aromatase inhibitors (Prolia).
Treatment of bone loss in prostate cancer patients receiving androgen deprivation therapy (Prolia).
NEW INDICATION: Treatment of adults and adolescents with unresectable giant cell tumor of the bone (Xgeva)Contraindications and Cautions
Contraindicated with known hypersensitivity to components of drug; lactation, hypocalcemia (Prolia).
Use cautiously with current infections, pregnancy.
Available Forms
Single-use vial—60 mg/mL; prefilled syringe—60 mg/mL
Dosages
Adults
Osteoporosis (Prolia only): 60 mg by subcutaneous injection in upper arm, thigh, or abdomen every 6 mo. Give with 1,000 mg calcium and at least 400 units vitamin D daily.
Bone metastases from solid tumors (Xgeva only): 120 mg by subcutaneous injection every 4 wk. Give with calcium and vitamin D as necessary to treat or prevent hypocalcemia.
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