Reclast label changed for renal dysfunction

FDA is now requiring prescribing information for Reclast (zoledronic acid injection, Novartis) to include a warning against use of the drug by patients with renal dysfunction. Specifically, the revised label lists as contraindications to use of Reclast:

• a creatinine clearance of less than 35 mL/min, or
• evidence of acute renal impairment.

The revised label will also recommend that providers monitor serum creatinine before and after administration of the drug.

This label change was announced in an FDA drug safety communication released online September 1. 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.

FDA cites 2 reviews of post-marketing surveillance data as the main impetus for this label change. During these reviews, FDA identified 16 deaths resulting from acute renal failure following administration of Reclast, as well as 9 cases of renal injury requiring dialysis. Underlying moderate-to-severe renal impairment, concomitant use of nephrotoxic drugs or diuretics, and severe dehydration were identified by FDA as risk factors for these Reclast-associated negative outcomes.

Of note, these revisions apply only to the Reclast label and not to that of Zometa, the name under which zoledronic acid is marketed when it is 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.

For more information, go to:

• The FDA drug safety communication: FDA Reclast, or
• The prescribing information:Reclast PI.