Zondrax Dosage/Direction for Use

Zoledronic Acid must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates. Patients treated with Zoledronic Acid should be given the package leaflet and the patient reminder card.
Posology: 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: Zoledronic Acid 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.
Prevention of skeletal related events in patients with advanced malignancies involving bone: When initiating treatment with zoledronic acid in patients with multiple myeloma or metastatic bone lesions from solid tumours, serum creatinine and creatinine clearance (CLcr) should be determined. CLcr is calculated from serum creatinine using the Cockcroft-Gault formula. Zoledronic acid is not recommended for patients presenting with severe renal impairment prior to initiation of therapy, which is defined for this population as CLcr <30 mL/min. In clinical trials with zoledronic acid, 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 CLcr 30-60 mL/min, the following zoledronic acid dose is recommended: See Table 1.

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Following initiation of therapy, serum creatinine should be measured prior to each dose of zoledronic acid 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 serum creatinine (>1.4 mg/dL or >124 μmol/L), an increase of 1.0 mg/dL or 88 μmol/L.
In the clinical studies, zoledronic acid treatment was resumed only when the creatinine level returned to within 10% of the baseline value. Zoledronic acid treatment 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. No recommended dose is currently available for this population.
Method of administration: Intravenous use: Zoledronic Acid 4 mg concentrate for solution for infusion, further diluted in 100 mL, should be given as a single intravenous infusion in no less than 15 minutes.
In patients with mild to moderate renal impairment, reduced zoledronic acid doses are recommended.
Instructions for preparing reduced doses of Zoledronic Acid: 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 3.0 mg dose.
For instructions on the dilution of zoledronic acid before administration. 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.
Zoledronic Acid 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 zoledronic acid.