Zoledronic acid concentrate for solution for i v infusion. Each 5ml vial concentrate contains zoledronic acid INN 4mg (calculated as the anhydrous form, corresponding to 4,265mg zoledronic acid monohydrate Ind: Hypercalcemia of malignancy. Zoledronic acid is indicated for the treatment & prevention of skeletal-related events (pathological fracture, spinal cord compression, radiation to bone or sur­gery to bone) in patients with advanced malignancies involving bone.

Multiple myeloma and bone metastases of solid tumors: Zoledronic acid is indicated for the treatment of patients with multiple myeloma and patients with bone metastases from solid tumors (breast cancer, prostate cancer, lung cancer, and other solid tumors) in conjunction with standard anti-neoplastic therapy.

C/I; S/E; Precaution: See above under the text. Dosage & admin: Hypercalcemia of malignancy: The maximum recommended dose in hypercalcemia of malignancy (serum calcium 12mg/dl or 3.0mmol/l) is 4mg. The 4mg dose must be given as a single-dose i.v infusion. Dose adjustment is not necessary in treating patients for hypercalcemia of malignancy presenting with mild-to-moderate renal impairment. Re-treatment with zoledronic acid may be considered if serum calcium does not return to normal after initial treatment. It is recommended that a minimum of 7 days elapse before re-treatment, to allow for full response to the initial dose.

Multiple myeloma and bone metastases of solid tumors: The recommended dose in patients with multiple myeloma and metastatic bone lesions from solid tumors is 4mg infused every 3-4 weeks. Patients should also be administered an oral calcium supplement of 500mg and 400 IU of vitamin-D daily. Preparation of solution & method of administration: Prior to administration, the required amount of concentrate from one vial must be further diluted with 100 ml of calcium-free infusion solution (0.9 % w/v sodium chloride solution or 5 % w/v glucose solution). The duration of infusion must not be less than 15 minutes. After addition of the solution to the infusion media, the infusion solution should be used as soon as possible.

If storage of the infusion solution is necessary, hold at 2-8 °C for not more than 24 hours. If refrigerated, the solution must be allowed to reach room temperature before administration.

(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).

Drug inter: See above under the text.