Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or bone surgery) in patients with bone metastases from solid tumours.

Subcutaneous Injection: 120 mg once every 4 wk into thigh, abdomen or upper arm. Ca & vitamin D supplements should be given whilst undergoing treatment.

Hypersensitivity to denosumab or to any of the excipients.

Dyspnoea, Hypocalcaemia, hypophosphataemia, Osteonecrosis of the Jaw (ONJ).

Overdose Effects

There is no experience with overdose in clinical studies. Denosumab has been administered in clinical studies using doses up to 180 mg every 4 weeks (cumulative doses up to 1,080 mg over 6 months), and no additional adverse reactions were observed.

Correct preexisting hypocalcaemia prior to therapy. Osteonecrosis of the jaw (ONJ). Perform oral & dental exam with preventive dentistry prior to treatment. Avoid invasive dental procedures & maintain good oral hygiene while on treatment. Atypical femoral fractures. Severe renal impairment (CrCl <30 ml/min) or in patients receiving dialysis. Concomitant use with other denosumab-containing prep. Pregnancy & lactation. Children.

Pregnancy & Lactation

Pregnancy Category D. There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).