Xolnic Special Precautions

General: Standard hypercalcaemia-related metabolic parameters, such as serum levels of calcium, phosphate and magnesium as well as serum creatinine should carefully monitored after initiating Zoledronic acid injection. If hypocalcaemia, hypophosphatemia, or hypomagnesemia occur, short-term supplemental therapy may be necessary.
Patient with hypercalcaemia of malignancy must be adequately rehydrated prior to administration of Zoledronic acid. Loop diuretics should not be used until the patient is adequately rehydrated and should be used with caution in combination with Zoledronic acid in order to avoid hypocalcaemia. Zoledronic acid should be used with caution with other nephrotoxic drugs.
Renal Insufficiency: Zoledronic acid is excreted intact primarily via kidney, and the risk of adverse reactions, in particular renal adverse reactions, may be greater in patients treated with impaired renal function. Serum creatinine should be monitored in all patients treated with Zoledronic acid prior to each dose.
Zoledronic acid has not been tested in patients with severe renal impairment (serum creatinine >4.5 mg/ml). Therefore, its use is not recommended in this patient population.
Hepatic Insufficiency: Only limited clinical data are available for use of Zoledronic acid to treat hypercalcaemia of malignancy in patients with hepatic insufficiency, therefore, dosage recommendation cannot be given for the group.
Patient with Asthma: While not observed in clinical trial with Zoledronic acid, administration of other bisphosphonates has been associated with bronchoconstriction in aspirin-sensitive asthma.
Laboratory Test: Serum creatinine should be monitored prior to each dose of Zoledronic acid. Serum calcium, electrolytes, Phosphate, magnesium, and hematocrit/hemoglobin must be monitored closely in patients treated with Zoledronic acid.
Effects on ability to drive and use machine: Not known.
Use in Children: The safety and effectiveness of Zoledronic acid in pediatric patients have not been established. Because of long-term retention in bone, Zoledronic acid should only be used in children if the potential risk.
Use in the Elderly: No significant differences in response rate or adverse reactions were seen in geriatric patients receiving Zoledronic acid as compared to younger patients.