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At a glance

Denosumab is a monoclonal antibody that prevents bone loss in osteoporosis and reduces the risk of fractures.

Indications
  • Postmenopausal osteoporosis at high risk for fracture
  • Bone mass increase in men with osteoporosis
  • Glucocorticoid-induced osteoporosis
  • Bone loss in men receiving androgen deprivation therapy for prostate cancer
  • Bone loss in women receiving adjuvant aromatase inhibitor therapy for breast cancer
  • Prevention of skeletal-related events in multiple myeloma and bone metastases from solid tumors
  • Giant cell tumor of bone
  • Hypercalcemia of malignancy refractory to bisphosphonate therapy
Pharmacology

Denosumab is a human IgG2 monoclonal antibody with affinity and specificity for human RANKL. Denosumab binds to RANKL, a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function, and survival, thereby decreasing bone resorption and increasing bone mass and strength.

Dosage

Osteoporosis and Bone Loss: 60 mg SC every 6 months.
Multiple Myeloma and Bone Metastasis: 120 mg SC every 4 weeks.
Giant Cell Tumor: 120 mg SC every 4 weeks (with additional 120 mg on Days 8 and 15 of the first month).
Hypercalcemia of Malignancy: 120 mg SC every 4 weeks (with additional 120 mg on Days 8 and 15 of the first month).

Side effects

Postmenopausal osteoporosis: Back pain, pain in extremity, hypercholesterolemia, musculoskeletal pain, cystitis.
Male osteoporosis: Back pain, arthralgia, nasopharyngitis.
Bone metastasis: Fatigue, hypophosphatemia, nausea.
Multiple myeloma: Diarrhea, nausea, anemia, thrombocytopenia.

Use in pregnancy

Pregnancy Category X. Denosumab is highly unsafe during pregnancy. May cause fetal harm. Females of reproductive potential should use effective contraception during therapy and for at least 5 months after the last dose.

Pregnancy Category: X — always consult a doctor before taking during pregnancy.

Precautions & warnings

Hypocalcemia: Correct before initiating therapy; Osteonecrosis of the jaw; Atypical femoral fractures; Multiple vertebral fractures following discontinuation; Serious infections including skin infections; Severe pain; Suppression of bone turnover; Embryo-fetal toxicity.

Overdose effects

Treatment of overdose should consist of observation and general supportive measures.

Storage conditions

Store in a refrigerator at 2°C to 8°C in the original carton. Do not freeze. Once removed from the refrigerator, use within 14 days.

Denosumab — see the full informationPharmacology, precautions, pregnancy, overdose and the rest on the generic page
⚠️ This information is for educational purposes only — not a substitute for medical advice. Consult a registered physician before taking any medicine.