Zolepex Dosage/Direction for Use

Prior to IV infusion of Zoledronic acid to patients the concentrated solution must be diluted as directed.
Preparation of the solution for intravenous infusion and administration: ZOLEPEX must be diluted in 100 mL of appropriate infusion solution such as 0.9% sodium chloride injection or 5% dextrose injection before being administered by IV infusion over not less than 15 minutes.
If diluted solution is not used immediately and stored in refrigerator (at 2-8°C). It is necessary to equilibrate the refrigerated solution to room temperature prior to administration. For microbiology integrity, the total time between dilution, storage in refrigerator, and end of administration must not exceed 24 hours.
An adjunct to antineoplastic therapy for the treatment of bone metastases of solid tumors and osteolytic lesions of multiple myeloma, and reduction of bone damage in patients with advanced malignancies involving bone: Recommended dosage of diluted solution is 4 mg of Zoledronic acid as a single dose.
ZOLEPEX must be diluted in 100 mL of appropriate infusion solution such as 0.9% sodium chloride injection or 5% dextrose injection before being administered by IV infusion over not less than 15 minutes and given IV once every 3-4 weeks.
Patients should be received supplemental therapy with 500 mg of calcium and 400 units of vitamin D daily.
Dosage in Hypercalcemia of malignancy (HCM): Recommended dosage of diluted solution in hypercalcemia of malignancy (albumin-corrected serum calcium is at least 12.0 mg/dL or 3.0 mmol/L) is 4 mg of Zoledronic acid as a single dose.
ZOLEPEX must be diluted in 100 mL of appropriate infusion solution such as 0.9% sodium chloride injection or 5% dextrose injection before being administered by IV infusion over not less than 15 minutes.
Patient should be appropriately hydrated prior to administration and throughout the treatment.
Zoledronic acid is not recommended for the treatment of hypercalcemia of malignancy in patients with severe renal function impairment (The treatment should be considered only after evaluating the risks and benefits of treatment).
No dose adjustment is needed in patients with hypercalcemia of malignancy and mild to moderate renal impairment (Serum creatinine less than 400 μmol/L or 4.5 mg/dL).
Dosage in renal impairment: In patients with bone metastases of solid tumors and osteolytic lesions of multiple myeloma and mild to moderate renal function impairment dosage adjustments should be adjusted based on renal function listed in the table as follows. (See Table 1.)

Click on icon to see table/diagram/image

ZOLEPEX must be diluted in 100 mL of appropriate infusion solution such as 0.9% sodium chloride injection or 5% dextrose injection before being administered by IV infusion over not less than 15 minutes.
ZOLEPEX is not recommended in patients with severe renal impairment (Creatinine clearance less than 30 mL/min). During treatment, special care should be taken to monitor renal function and measure serum creatinine before each Zoledronic acid dose and withhold treatment for renal deterioration.
Renal deterioration is defined as follows: Increase in serum creatinine more than or equal to 44 μmol/L or 0.5 mg/dL for patients with normal baseline serum creatinine (less than 1.4 mg/dL), before treatment.
Increase in serum creatinine more than or equal to 88 μmol/L or 1 mg/dL for patients with an abnormal baseline serum creatinine (greater than 1.4 mg/dL), before treatment.
Zoledronic acid treatment is resumed only when the serum creatinine returned to within 10% of the baseline value (or serum creatinine up to 3.0 mg/dL).
Dosage in pregnancy and lactation: There is no adequate safety information on Zoledronic acid usage in pregnant woman.
It is not known whether zoledronic acid is present in human milk, or whether it affects milk production or the breastfed child, advise a lactating woman not to breastfeed during and after treatment.
Dosage in pediatric patients: Due to inadequate safety and efficacy information of drug used in pediatric patients, ZOLEPEX is not indicated for use in children.