Post-marketing reports of renal impairment associated with zoledronic acid 5mg solution for infusion (Aclasta®)

Novartis would like to update healthcare professionals on post-marketing reports of renal impairment following administration of Aclasta®. As of 14 Aug 09, there have been 139 reports of renal impairment, corresponding to a reporting rate of 18 cases per 100,000 patient-years. Majority of the cases were reported in patients with pre-existing medical conditions, risk factors (advanced age, renal impairment, concurrent or preceding dehydration), or with concurrent exposure to nephrotoxic agents. Rare cases of renal failure requiring dialysis or with fatal outcomes have also been reported. Physicians are advised to consider thoroughly their patient's renal function before initiating Aclasta® and not to use it in patients with severe renal impairment (CrCl < 35ml/min). Physicians are encouraged to consult the updated Aclasta® package insert available on HSA website before prescribing it to patients.