Published: June 2010


Zoledronic acid associated with adverse effects on renal function

Information on this subject has been updated. Read the most recent information.

Prescriber Update 31(2): 17
June 2010

Prescribers are advised that zoledronic acid is associated with reports of renal impairment and renal failure, especially in patients with pre-existing renal dysfunction.

Two products containing zoledronic acid are available in New Zealand. Aclasta (zoledronic acid 5 mg injection) is indicated for the prevention or treatment of osteoporosis and the treatment of Paget's Disease of the bone.1 Zometa (zoledronic acid 4 mg injection) is indicated for the treatment of osteolytic, osteoblastic and mixed bone metastases of solid tumour in cancer of the breast or prostate, and in the treatment of hypercalcaemia of malignancy.2

The data sheets for both products contain warnings about renal impairment and renal failure.

The manufacturer of Aclasta has recently issued advice to healthcare professionals about reports of renal impairment and renal failure.3

Worldwide, as of August 2009, there have been 139 suspected reports of renal impairment or renal failure associated with Aclasta. The majority of cases were reported in patients with pre-exisitng medical conditions (advanced age, renal impairment, concurrent or preceding dehydration), or who had concurrent treatment with nephrotoxic agents such as NSAIDs and/or diuretics). The following is advised to reduce the risk of renal adverse reactions:

  • Creatinine clearance should be measured before each dose.
  • Aclasta should not be used in patients with a creatinine clearance < 35 mL/min.
  • Transient increases in serum creatinine may be greater in patients with underlying impaired renal function.
  • Monitoring renal function should be considered, particularly in at-risk patients.
  • Zoledronic acid should be used with caution with other medicines that could impair renal function.
  • Healthcare professionals should ensure that all patients, especially the elderly and those receiving diuretics, are adequately hydrated prior to receiving zoledronic acid.
  • Zoledronic acid infusions should be administered over at least 15 minutes.

Further information is available from the data sheets available on the Medsafe website at:

  1. Novartis New Zealand Ltd. 16 December 2009. Aclasta (zoledronic acid) data sheet.
  2. Novartis New Zealand Ltd. 8 June 2009. Zometa (zoledronic acid) data sheet.
  3. Novartis New Zealand Ltd. 11 March 2010. Aclasta (zoledronic acid 5 mg) Renal Education Letter. [Further information is available from Novartis Medical Information and Communication Department, phone 0800 354 335.


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