The April edition of the Drug Safety Update features information on the association between zoledronic acid and reports of renal impairment and renal failure, especially in patients with pre-existing renal dysfunction or other risk factors. The following advice is provided for healthcare professionals, in order to minimise the risk of renal adverse reactions with zoledronic acid:
• Renal function should be measured before each infusion of zoledronic acid
• Patients, especially elderly patients and those receiving diuretic therapy, should be appropriately hydrated before administration of zoledronic acid
• The duration of infusion of zoledronic acid should be at least 15 minutes
• Monitoring of renal function after zoledronic acid infusion should be considered, particularly in at-risk patients such as: those with pre-existing renal dysfunction; those of advanced age; those using concomitant nephrotoxic drugs or diuretic therapy; or those who are dehydrated
• Zoledronic acid should be used with caution when used concomitantly with medicines that could affect renal function
For patients receiving Aclasta (zoledronic acid 5 mg for infusion for the once-yearly treatment of osteoporosis in patients at increased risk of fracture, and as a single dose for the treatment of Paget’s disease of the bone):
• A single dose of Aclasta for the treatment of osteoporosis and Paget’s disease of the bone should not exceed 5 mg
• Aclasta should not be used in patients with creatinine clearance <35 mL/min
For patients receiving Zometa (zoledronic acid 4 mg for infusion given every 3–4 weeks for the reduction of bone damage in advanced malignancies involving bone, and as a single dose for tumour-induced hypercalcaemia):
• The recommended dose for Zometa in patients with normal renal function is 4 mg, which should be reduced in patients with mild-to-moderate renal impairment
• Zometa for cancer treatment is not recommended for use in patients with creatinine clearance <30 mL/min, and should only be considered for the treatment of hypercalcaemia in cancer patients with severe renal impairment after evaluating the risk and benefits of treatment
• In patients who show evidence of renal deterioration during the treatment period, Zometa should be with-held and only resumed when serum creatinine returns to within 10% of baseline