Zoledronic Acid Monohydrate 4 mg/100 ml

Dosage

0-18 Years Old

The safety and efficacy of zoledronic acid in pediatric patients have not been established.

18 Years Old and Above

Prevention of skeletal related events in patients with advanced malignancies involving bone

The recommended zoledronic acid dose is 4 mg infusion given 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 hypercalcemia of malignancy

The recommended zoledronic acid dose in hypercalcemia (albumin-corrected serum calcium ≥12.0 mg/dl or 3.0 mmol/l) is a single dose of 4 mg zoledronic acid.

Patients with Renal Impairment

Hypercalcemia of malignancy (HCM)

Zoledronic acid treatment in adult patients with HCM who also have severe renal impairment should be considered only after evaluating the risks and benefits of treatment. No dose adjustment is necessary in HCM patients with serum creatinine <400 micromol/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 tumors, serum creatinine levels and creatinine clearance (Clcr) should be determined. 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 adult patients with bone metastases presenting with mild to moderate renal impairment prior to initiation of therapy (with CrCl 30 to 60 ml/minute), the following zoledronic acid dose is recommended:

CrCl >60 : recommended dose of zoledronic acid is 4.0 mg

CrCl 50-60 : recommended dose of zoledronic acid is 3.5 mg *

CrCl 40-49 : recommended dose of zoledronic acid is 3.3 mg *

CrCl 30-39 : recommended dose of zoledronic acid is 3.0 mg *

* Doses have been calculated assuming target AUC of 0.66 (mg.hr/l) (Clcr= 75 ml/min).

Patients with Hepatic Impairment

As only limited clinical data are available in patients with severe hepatic insufficiency, no specific recommendations can be given for this patient population.

Method of Administration

Zoledronic acid must only be administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.

The zoledronic acid solution for infusion is a "ready-to use" presentation and must not be further diluted or mixed with other infusion solutions except for patients with renal impairment.

Zoledronic acid 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 line separate from all other drugs in no less than 15 minutes. Patients must be maintained in a well hydrated state prior to and following administration of zoledronic acid.