Drug Class Description
Bisphosphonate

Generic Name
Zoledronic

Drug Description
One vial with 5 ml concentrate contains 4 mg zoledronic acid (anhydrous).One ml concentrate contains zoledronic acid (as monohydrate) corresponding to 0.8 mg zoledronic acid (anhydrous).

Presentation
Concentrate for solution for infusion

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

Adult Dosage
Zometa must only be used by clinicians experienced in the administration of intravenous bisphosphonates.Zometa concentrate must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer's solution, and should be administered as a single intravenous solution in a separate infusion line.Prevention of skeletal related events in patients with advanced malignancies involving boneAdults and elderlyThe recommended dose in the prevention of skeletal related events in patients with advanced malignancies involving bone is 4 mg zoledronic acid. The concentrate must be further diluted with 100 ml sterile 0.9% w/v sodium chloride or 5% w/v glucose solution and given in no less than a 15-minute intravenous infusion every 3 to 4 weeks.Patients should also be administered an oral calcium supplement of 500 mg and 400 IU vitamin D daily.Treatment of TIHAdults and elderlyThe recommended dose in hypercalcaemia (albumin-corrected serum calcium 12.0 mg/dl or 3.0 mmol/l) is 4 mg zoledronic acid. The concentrate must be further diluted with 100 ml sterile 0.9% w/v sodium chloride or 5% w/v glucose solution and given as a single intravenous infusion in no less than 15 minutes. Patients must be maintained well hydrated prior to and following administration of Zometa.Renal impairmentTIH:Zometa treatment in TIH patients who also have severe renal impairment should be considered only after eva luating the risks and benefits of treatment. In the clinical studies, patients with serum creatinine > 400 µmol/l or > 4.5 mg/dl were excluded. No dose adjustment is necessary in TIH patients with serum creatinine < 400 µmol/l or < 4.5 mg/dl.Prevention of skeletal related events in patients with advanced malignancies involving bone:When initiating treatment with Zometa in patients with multiple myeloma or metastatic bone lesions from solid tumours, serum creatinine and creatinine clearance (CrCl) should be determined. CrCl is calculated from serum creatinine using the Cockcroft-Gault formula. Zometa is not recommended for patients presenting with severe renal impairment prior to initiation of therapy, which is defined for this population as CrCl < 30 ml/min. In clinical trials with Zometa, patients with serum creatinine > 265 µmol/l or > 3.0 mg/dl were excluded.In patients with bone metastases presenting with mild to moderate renal impairment prior to initiation of therapy, which is defined for this population as CrCl 30–60 ml/min, the following Zometa dose is recommended:Baseline Creatinine Clearance (ml/min)Zometa Recommended Dose*> 604.0mg50-603.5mg*40-493.3mg*30-393.0mg**Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CrCl=75 ml/min). The reduced doses for patients with renal impairment are expected to