Zondrax

Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone or tumour-induced hypercalcemia) in adult patients w/ advanced malignancies involving bone. Treatment of tumour-induced hypercalcaemia (TIH) in adults.

IV Dose must be given as a single IV infusion over no less than 15 min. Adult & older patient Prevention of skeletal related events in advanced malignancies involving bone 4 mg every 3-4 wk. Patient w/ CrCl 50-60 mL/min 3.5 mg every 3-4 wk, 40-49 mL/min 3.3 mg every 3-4 wk, CrCl 30-39 mL/min 3 mg every 3-4 wk. Treatment of TIH 4 mg as a single dose.

Hypersensitivity to zoledronic acid or to other bisphosphonates. Lactation.

Assess patients prior to administration to ensure adequate hydration. Avoid overhydration in patients at risk of cardiac failure. Carefully monitor serum levels of Ca, phosphate & Mg after initiating therapy. Reports of renal dysfunction; osteonecrosis of the jaw (ONJ); osteonecrosis of the external auditory canal, mainly in association w/ long-term therapy; osteonecrosis of other sites, including hip & femur, predominantly in adult cancer patients; severe & occasionally incapacitating bone, joint, &/or muscle pain; atypical subtrochanteric & diaphyseal femoral fractures, primarily in patients receiving long-term treatment for osteoporosis; hypocalcaemia. Assess serum creatinine levels prior to each dose. W/hold treatment in patients who show evidence of renal deterioration during treatment. Delay start of treatment or new course of treatment in patients w/ unhealed open soft tissue lesions in the mouth, except in medical emergency situations. Avoid invasive dental procedures in close proximity to zoledronic acid administration. Do not concomitantly use w/ other zoledronic acid or any other bisphosphonate. Caution when administered w/ medicinal products known to cause hypocalcaemia. Patients should be adequately supplemented w/ Ca & vit D. May influence ability to drive or use machine. Not recommended in patients w/ severe renal impairment. Should not be used during pregnancy.

Hypophosphataemia. Anaemia; headache; conjunctivitis; nausea, vomiting, decreased appetite; bone pain, myalgia, arthralgia, generalised pain; renal impairment; fever, flu-like syndrome (eg, fatigue, rigors, malaise & flushing); increased blood creatinine & blood urea, hypocalcaemia.

May cause lower serum Ca level w/ aminoglycosides, calcitonin or loop diuretics. Additive effect on renal function & possible hypomagnesaemia w/ other potentially nephrotoxic medicines. Increased risk of renal dysfunction w/ thalidomide in multiple myeloma patients. Increased incidence of ONJ w/ anti-angiogenic medicines.

Agents Affecting Bone Metabolism

M05BA08 - zoledronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.

Rx