achieve the same AUC as that seen in patients with creatinine clearance of 75 ml/min.Following initiation of therapy, serum creatinine should be measured prior to each dose of Zometa and treatment should be withheld if renal function has deteriorated. In the clinical trials, renal deterioration was defined as follows:For patients with normal baseline serum creatinine (< 1.4 mg/dl or < 124 µmol/l), an increase of 0.5 mg/dl or 44 µmol/l;For patients with an abnormal baseline creatinine (> 1.4 mg/dl or > 124 µmol/l), an increase of 1.0 mg/dl or 88 µmol/l.In the clinical studies, Zometa treatment was resumed only when the creatinine level returned to within 10% of the baseline value. Zometa treatment should be resumed at the same dose as that prior to treatment interruption.Instructions for preparing reduced doses of ZometaWithdraw an appropriate volume of the concentrate needed, as follows:4.4 ml for 3.5 mg dose4.1 ml for 3.3 mg dose3.8 ml for 3.0 mg doseThe withdrawn amount of concentrate must be further diluted in 100 ml of sterile 0.9% w/v sodium chloride solution or 5% w/v glucose solution. The dose must be given as a single intravenous infusion over no less than 15 minutes.The use of Zometa in paediatric patients has not been studied. Zometa should not be used in that patient population until further data becomes available.
Child Dosage
Not recommended.
Contra Indications
Zometa concentrate is contraindicated in breast-feeding women and in patients with clinically significant hypersensitivity to zoledronic acid, other bisphosphonates or any of the excipients in the formulation of Zometa.
Special Precautions
GeneralPatients must be assessed prior to administration of Zometa to ensure that they are adequately hydrated.Overhydration should be avoided in patients at risk of cardiac failure.Standard hypercalcaemia-related metabolic parameters, such as serum levels of calcium, phosphate and magnesium, should be carefully monitored after initiating Zometa therapy. If hypocalcaemia, hypophosphataemia, or hypomagnesaemia occurs, shortterm supplemental therapy may be necessary. Untreated hypercalcaemia patients generally have some degree of renal function impairment, therefore careful renal function monitoring should be considered.The safety and efficacy of Zometa in paediatric patients have not been established.Renal insufficiencyPatients with TIH with evidence of deterioration in renal function should be appropriately eva luated with consideration given as to whether the potential benefit of treatment with Zometa outweighs the possible risk.The decision to treat patients with bone metastases for the prevention of skeletal related events should consider that the onset of treatment effect is 2–3 months.As with other bisphosphonates, Zometa has been associated with reports of renal dysfunction. Factors that may increase the potential for deterioration in renal function include dehydration, pre-existing renal impairment, multiple cycles of Zometa and other bisphosphonates as well as use of other nephrotoxic drugs. While the risk is reduced with a dose of Zometa 4 mg administered over 15 minutes, deterioration in renal function may still occur. Renal deterioration, progression to renal failure and dialysis have been reported in patients after the initial dose or a single dose of Zometa. Increases in serum creatinine also occur in some patients with chronic administration of Zometa at reco
