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Facts About Zometa
02.26.02
FACTS ABOUT ZOMETA®
(zoledronic acid for injection)

(This fact sheet has been provided by Novartis)

DESCRIPTION
ZOMETA® (zoledronic acid for injection), developed by Novartis, is a new generation intravenous (IV) bisphosphonate. Among bisphosphonates, laboratory tests demonstrate that ZOMETA is the most potent inhibitor of bone resorption, the process by which abnormal amounts of calcium are released into the blood stream. Further, ZOMETA offers patients, nurses and clinicians a convenient 4 mg, 15-minute infusion time.

APPROVED INDICATIONS
ZOMETA was approved by the U.S. Food and Drug Administration (FDA) on February 22, 2002 for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. These solid tumors include prostate cancer, lung cancer, breast cancer and other solid tumor types. In prostate cancer, patients should have progressed after treatment with at least one hormonal therapy. The trials that led to the approval of ZOMETA mark the first time any bisphosphonate has demonstrated efficacy in treating bone complications in patients with prostate cancer, lung cancer and other solid tumors.

In the U.S., Novartis received marketing clearance for ZOMETA in the treatment of hypercalcemia of malignancy (HCM), also known as tumor-induced hypercalcemia (TIH) on August 20, 2001. HCM is the most common life-threatening metabolic complication associated with cancer.

ZOMETA AND BONE METASTASES
The risk of skeletal complications is very high in patients with bone metastases. ZOMETA is a unique approach to treating these complications. It inhibits the bone loss, or resorption, induced by bone cells known as osteoclasts, that weaken the bone structure. Similarly, ZOMETA affects osteoblasts (cells that assist in the formation of bone tissue), tumor cells and cytokine and growth-factor production, and thereby may interrupt the vicious cycle of bone destruction. ZOMETA is unique in that it successfully affects both osteoclast and osteoblast activity helping to stabilize their balance and lead to more natural bone metabolism.

ADVERSE EVENTS
ZOMETA, and other bisphosphonates, have been associated with reports of renal insufficiency. Patients should have serum creatinine assessed prior to receiving each dose of ZOMETA. In multiple myeloma, the risk of renal dysfunction may be increased with ZOMETA if used in combination with thalidomide. Doses of ZOMETA should not exceed 4 mg and the duration of infusion should be no less than 15 minutes.

In clinical trials in patients with bone metastases, ZOMETA was generally well tolerated, with a safety profile similar to other bisphosphonates. The most commonly reported adverse events included flu-like syndrome (fever, arthralgias, myalgias, skeletal pain), fatigue, gastrointestinal reactions, anemia, weakness, cough, dyspnea and edema. Occasionally, patients experienced electrolyte and mineral disturbances, such as low serum phosphate, calcium, magnesium and potassium. ZOMETA should not be used during pregnancy. ZOMETA is contraindicated in patients with clinically significant hypersensitivity to zoledronic acid or other bisphosphonates, or any of the excipients in the formulation of ZOMETA.

In the HCM clinical trials, ZOMETA was generally well tolerated with a safety profile similar to other bisphosphonates. The most commonly associated adverse events included flu-like syndrome (fever, arthralgias, myalgias, skeletal pain), gastrointestinal reactions, anemia, insomnia and dyspnea. Occasionally, patients experienced electrolyte and mineral disturbances, such as low serum phosphate, calcium, magnesium and potassium.


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