Reclast ( Zoledronic Acid, Zoledronate; Europe: Aclasta ) is used to: a) treat or prevent osteoporosis in women after menopause. Reclast helps reduce the chance of having a hip or spinal fracture; b) increase bone mass in men with osteoporosis; c) treat or prevent osteoporosis in either men or women who take corticosteroid medications for at least one year; d) treat men and women who have Paget's disease of the bone.

Reclast is given as an intravenous infusion in a single dose, once every 1 to 2 years. The infusion time should be no less than 15 minutes.

Cases of acute renal failure requiring dialysis or having a fatal outcome following Reclast use have been reported to FDA ( Food and Drug Administration ).

The FDA has approved an update to the drug label for Reclast to better inform healthcare professionals and patients of the risk of kidney failure.
Kidney failure is a rare, but serious, condition associated with the use of Reclast in patients with a history of or risk factors for renal impairment.

Risk factors for developing renal failure include underlying moderate to severe renal impairment, use of nephrotoxic or diuretic medications at the same time as Zoledronic Acid, or severe dehydration occurring before or after Reclast is given. The risk of developing renal failure in patients with underlying renal impairment also increases with age.

The revised label states that Reclast should not be used ( is contraindicated ) in patients with creatinine clearance less than 35 mL/min or in patients with evidence of acute renal impairment.
The label also recommends that healthcare professionals screen patients prior to administering Reclast in order to identify at-risk patients.
Healthcare professionals should also monitor renal function in patients who are receiving Reclast.

A January 2009 FDA post-market safety review identified five deaths from acute renal failure following Reclast infusion.
Based on that review, the Warnings and Precautions section of the Reclast label was updated in March 2009, with a recommendation to monitor serum creatinine before each dose of Reclast and included reports of renal impairment from clinical studies.
FDA continued to note reports of renal failure to the Agency's Adverse Event Reporting System ( AERS ) after the March 2009 label revision.
A follow-up review in April 2011 showed an additional 11 cases of fatal acute renal failure and 9 cases of renal injury requiring dialysis after Reclast infusion.

These labeling changes are being made to the Reclast label only, although Zoledronic Acid, also sold as Zometa, is approved for treatment of cancer-related indications.
Renal toxicity is already addressed in the Warnings and Precautions section of the Zometa label as well as in the Reclast label.
Dose reductions for Zometa are provided for patients with renal impairment.

Source: FDA, 2011

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