Zometa Dosage/Direction for Use

Zometa must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.
Prevention of skeletal related events in patients with advanced malignancies involving bone: Adults and older people The recommended dose in the prevention of skeletal related events in patients with advanced malignancies involving bone is 4 mg zoledronic acid every 3 to 4 weeks.
Patients should also be administered an oral calcium supplement of 500 mg and 400 IU vitamin D daily.
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.
Treatment of TIH: Adults and older people: The recommended dose in hypercalcaemia (albumin-corrected serum calcium ≥12.0 mg/dL or 3.0 mmol/L) is a single dose of 4 mg zoledronic acid.
Renal impairment: TIH: Zometa treatment in TIH patients who also have severe renal impairment should be considered only after evaluating 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 (see Precautions).
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 (see Precautions): See Table 6.

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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 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 (see Precautions). Zometa should be resumed at the same dose as that given prior to treatment interruption.
Paediatric population: The safety and efficacy of zoledronic acid in children aged 1 year to 17 years have not been established. Currently available data are described in Pharmacology: Pharmacodynamics under Actions but not recommended on a posology can be made.
Method of administration: Intravenous use.
Concentrate for soln for infusion 4 mg/5 mL: Zometa 4 mg concentrate for solution for infusion, further diluted in 100 mL (see Cautions for Usage), should be given as a single intravenous infusion in no less than 15 minutes.
In patients with mild to moderate renal impairment, reduced Zometa doses are recommended (see previously mentioned and Precautions).
Instructions for preparing reduced doses of Zometa: Withdraw an appropriate volume of the concentrate needed, as follows: 4.4 mL for 3.5 mg dose, 4.1 mL for 3.3 mg dose, 3.8 mL for 3 mg dose.
For instructions on the dilution of the medicinal product before administration, see Cautions for Usage. The 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.
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.
Patients must be maintained well hydrated prior to and following administration of Zometa.