Zoledronic Acid
Composition:
Each vial contains Zoledronic Acid 4mg/5ml as Zoledronic Acid Monohydrate INN concentrate solution for IV infusion.
Indications:
Hypercalcemia of Malignancy: Zoledronic Acid is
indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected
calcium (cCa) of greater than or equal to 12mg/dL [3.0mmol/L] using the
formula: cCa inmg/dL=Ca in mg/dL + 0.8 (4.0 g/dL -patient albumin [g/dL]). Multiple Myeloma and Bone Metastases of
Solid Tumors: Zoledronic Acid is indicated for the treatment of patients
with multiple myeloma and patients with documented bone metastases from solid
tumors, in conjunction with standard antineoplastic therapy. Prostate cancer
should have progressed after treatment with at least one hormonal therapy. Important Limitation of Use: The safety
and efficacy of Zoledronic Acid in the treatment of hypercalcemia associated
with hyperparathyroidism or with other non tumor-related conditions have not
been established.
Dosage and Administration: Hypercalcemia of Malignancy: The maximum recommended dose of Zoledronic Acid in hypercalcemia of malignancy (albumin-corrected serum calcium greater than or equal to 12mg/dL [3.0mmol/L]) is 4mg. The 4mg dose must be given as a single-dose intravenous infusion over no less than 15 minutes. Patients who receive Zoledronic Acid should have serum creatinine assessed prior to each treatment. Dose adjustments of Zoledronic Acid are not necessary in treating patients for hypercalcemia of malignancy presenting with mild-to-moderate renal impairment prior to initiation of therapy (serum creatinine less than 400pmol/L or less than 4.5mg/dL). Retreatment with Zoledronic Acid 4mg may be considered if serum calcium does not return to normal or remain normal after initial treatment. It is recommended that a minimum of 7 days elapse before retreatment, to allow for full response to the initial dose. Renal function must be carefully monitored in all patients receiving Zoledronic Acid and serum creatinine must be assessed prior to retreatment with Zoledronic Acid. Multiple Myeloma and Metastatic Bone Lesions of Solid Tumors: The recommended dose of Zoledronic Acid in patients with multiple myeloma and metastatic bone lesions from solid tumors for patients with creatinine clearance (CrCl) greater than 60mL/min is 4mg infused over no less than 15 minutes every 3 to 4 weeks. The optimal duration of therapy is not known. Patients should also be administered an oral calcium supplement of 500mg and a multiple vitamin containing 400 international units of vitamin D daily. Patients with Renal Impairment: The use of Zoledronic Acid is not recommended in patients with severe renal impairment (Creatinine clearance < 30ml/min). No dose adjustment is necessary in patients with Creatinine clearance 60ml/min. Or, as directed by the registered physicians.
Use
in Pregnancy and Lactation: Pregnancy Category D. There are no
adequate and well-controlled studies of Zoledronic Acid in pregnant women. Zoledronic
Acid may cause fetal harm when administered to a pregnant woman. Nursing Mothers: It is not known
whether Zoledronic Acid is excreted in human milk. Because many drugs are
excreted in human milk, and because of the potential for serious adverse reactions
in nursing infants from Zoledronic Acid, a decision should be made to discontinue
nursing or to discontinue the drug, taking into account the importance of the
drug to the mother.
Packaging: Each box contains one vial of Zoledronic Acid INN 4mg/5ml concentrate solution for IV infusion.
