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U.S. Department of Health and Human Services

Safety

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Zometa (zoledronic acid)

Audience: Oncologists, Endocrinologists, Pharmacists and other healthcare professionals

Novartis and FDA notified healthcare professionals of revisions to the DOSAGE AND ADMINISTRATION and WARNINGS sections of the prescribing information to reflect new safety information on management of patients with advanced cancer and renal impairment, whose baseline creatinine clearance is 60 ml/min or lower. The recommended Zometa doses for patients with reduced renal function (mild and moderate renal impairment) are provided in a table. It is recommended that, during treatment, serum creatinine be measured before each dose and treatment should be withheld for renal deterioration.

[December 20, 2005 - Dear Healthcare Professional Letter - Novartis]