Distributor inventory | Injection

Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture; bone loss associated with androgen deprivation therapy (prostate cancer) or aromatase inhibitor therapy (breast cancer); increases bone mineral density and reduces fracture risk.

Denosumab is a monoclonal antibody against RANKL (receptor activator of nuclear factor kappa-B ligand). By inhibiting RANKL, it reduces formation, function and survival of osteoclasts, thereby decreasing bone resorption and increasing bone mass.

For subcutaneous use only. Usual adult dose: 60 mg (1 mL) once every 6 months, administered by a healthcare professional (thigh, abdomen, or upper arm). Ensure adequate calcium and vitamin D supplementation; use as advised by the doctor.

Back pain, musculoskeletal pain, pain in extremity, hypercholesterolaemia, urinary tract infection, upper respiratory tract infection, constipation, rash/eczema, injection site reactions, hypocalcaemia

Risk of hypocalcaemia—correct low calcium before starting and monitor calcium (especially in severe renal impairment/dialysis). Ensure calcium and vitamin D intake. Risk of serious infections and skin reactions; seek care for fever, cellulitis, or severe rash. Osteonecrosis of the jaw (ONJ) and atypical femoral fractures reported—maintain good oral hygiene, consider dental exam prior to therapy, report jaw pain or thigh/groin pain. Do not use in patients with hypersensitivity to denosumab. Avoid missing doses; stopping can increase risk of vertebral fractures—do not discontinue without medical plan. Not for IV/IM administration.

Other agents lowering calcium (loop diuretics, calcimimetics), corticosteroids or immunosuppressants (may increase infection/ONJ risk), bisphosphonates/other antiresorptives (additive effects—use only if prescribed).

Store refrigerated at 2–8°C. Do not freeze. Keep in original carton to protect from light. Before use, may be allowed to reach room temperature (do not heat); do not shake. Discard if cloudy or contains particles.

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