New Zometa Dosing for Patients with Renal Impairments June05


Novartis has notified healthcare professionals about new warnings and dosing recommendations for the company's bisphosphonate drug, Zometa (zoledronic acid). Zometa is used to treat multiple myeloma and metastatic bone lesions from solid tumors, and hypercalcemia of malignancy. The changes are intended to improve the renal safety of Zometa.The revised labeling includes an additional warning regarding patients with preexisting renal impairment who are undergoing multiple treatments with
Zometa and other bisphosphonates, because they may be at increased risk of renal deterioration.

The new dosing recommendations are intended for patients with advanced cancer who also have reduced renal function, that is, those patients whose baseline creatinine clearance is 60 ml/min or lower. The revised labeling stratifies the recommended Zometa doses for patients with mild and moderate renal impairment according the baseline creatinine clearance rates.

The company recommends that during Zometa treatment, serum creatinine be measured before each dose, and that treatment should be withheld when there's evidence of renal deterioration.







Channel: News
Uploaded: July 14, 2008 at 5:59 pm
Author: LawsuitGuru

Length: 00:01:22
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Tags: Zometa Patients Tumors Impairments Bisphosphonate FDA Metastatic Solid Dosing Bone Multiple Myeloma Lesions Renal

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