Zoledronic acid (Reclast) prescribing information to list renal dysfunction as contraindication

Key Points

FDA is requiring the zoledronic acid (Reclast, Novartis ) prescribing information to now include a warning not to use the drug in those with renal dysfunction. Specifically, the revised label lists a creatinine clearance less than 35 mL/min or evidence of acute renal impairment as contraindications to Reclast use. The revised label will also recommend providers monitor serum creatinine prior to administering Reclast, and that they continue to do so after patients have received the drug.

This labeling change was announced in an on-line FDA drug safety communication released on September 1, 2011. According to FDA officials, the revised label, "...will enhance the safe use of Reclast by providing healthcare professionals updated instructions for prescribing and patient monitoring."

When marketed as Reclast, zoledronic acid is used to treat or prevent osteoporosis in women after menopause, to increase bone mass in men with osteoporosis, to treat Paget's disease in men and women, and to prevent steroid-induced osteoporosis in men and women. Reclast is administered as a single intravenous dose once every 1 to 2 years, depending on the indication.

Of note, these revisions only apply to the Reclast, and not Zometa label, the name zoledronic acid is marketed under when used for cancer-related indications, FDA noted, "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 required for patients with renal impairment.