Denosumab

Drugs affecting Bone Metabolism · Monoclonal antibody

Indications

Treatment of osteoporosis in men and in postmenopausal women at high risk for fracture, treatment of bone less in men receiving androgen deprivation therapy (ADT) for nonmetastatic prostate cancer, treatment of bone loss in women receiving aromatase inhibitor therapy for breast cancer, prevention of skeletal-related events (e.g. fracture, spinal cord compression, bone pain requiring surgery/radiation therapy) in patients with bone metastases from solid tumours.

Dosage

SC: Adults: Prevention of skeletal-related events in bone metastases from solid tumours: 120 mg every 4 wk. Treatment of androgen deprivation-induced bone loss in men with prostate cancer: 60 mg as a single dose, once every 6 mth. Treatment of aromatase inhibitor-induced bone loss in women with breast cancer: 60 mg as a single dose, once every 6 mth. Treatment of osteoporosis in men or postmenopausal women: 60 mg as a single dose, once every 6 mth. Children: Not recommended.

Administration

Administer via SC inj in the upper arm, upper thigh or abdomen. Stability: Prior to use, store in original carton under refrigeration, 2°C-8°C. Do not freeze. Prior to use, bring to room temperature 25°C in original container (allow to stand for 15-30 min). Do not warm by any other method. Use within 14 days once at room temperature. Protect from direct heat and light. Do not expose to temperatures >25°C. Avoid vigorous shaking.

Adverse Effects

Nausea, fatigue, weakness, dyspnoea, pain in extremity.

Risk Factor (Pregnancy/Lactation)

Pregnancy: Positive evidence of risk: Use only when no safer alternative exists for a serious problem. Lactation: Contraindicated or not recommended.

Interactions

Immunosuppressants.

Pharmacokinetics

Bioavailability: 62%. Metabolism: Via Ig clearance pathways, resulting in degradation to small peptides and amino acids. Half-life elimination: Approx. 25-28 days. Time to peak, plasma: 10 days. Excretion: Via the reticuloendothelial system.

Brands with this active ingredient

• Denomab
• Denosurel
• Rexeva

Compiled by Healify Pharmacy from published drug references. How we compile it →

Always consult a pharmacist or doctor.