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Zometa for Treatment of Tumor-induced Hypercalcemia

Brand Name: Zometa
Active Ingredient: Zometa
Indication: Treatment of tumor-induced hypercalcemia
Company Name: Novartis Pharmaceuticals Corporation

Introduction

Tumor-induced hypercalcemia (TIH) most commonly develops in patients with advanced breast cancer, multiple myeloma, non-small cell lung cancer, and prostate cancer, and often occurs as a complication of bone metastases. TIH is potentially life-threatening, usually occurring late in malignancy and limiting survival. Signs and symptoms of tumor-induced hypercalcemia include nausea, vomiting, dehydration, renal insufficiency, mental confusion, and extremely high serum calcium levels (greater than 10.5 mg/dl).

How It Works

Cancer can accelerate the breakdown of bone, leading to tumor-induced hypercalcemia. Zometa is a biphosphonate that works by inhibiting osteoclastic bone resorption, the process by which calcium is released into the bloodstream. It is believed that biphosphonates become incorporated into bone matrix and are imbibed by osteoclasts during resorption, incapacitating the osteoclast and decreasing resorption.

ZometaZometa: Clinical Study Results

Two clinical studies compared Zometa to Aredia (pamidronate disodium for injection), another product of Novartis, which is currently used to treat tumor-induced hypercalcemia. The combined results showed that serum calcium levels returned to normal in a statistically significant higher percentage of patients receiving 4 mg Zometa (88.4%) versus those who received Aredia (70%). Moreover, Zometa was infused over 5 minutes, compared to the 2 or more hours required to infuse Aredia. (Zometa is 100-850 times more potent than Aredia.) Responses to Zometa are maintained for long durations (32-39 days). Novartis plans to present an abstract of the clinical trial data at the American Society of Clinical Oncology annual meeting this coming May.

Studies are also under way to assess Zometa for the treatment of bone metastases in patients with solid tumors (including breast, prostate, and lung cancers) and multiple myeloma. Trials to evaluate Zometa for the prevention of bone metastases in prostate cancer have already begun, and similar studies in breast cancer are about to start. Additional studies are planned to explore the potential antitumor effect of Zometa.

What the Patient Should Know

The most common adverse events reported by patients receiving Zometa were bone pain, anemia, fever, nausea, upper respiratory tract infections, fatigue, and constipation – an effects profile similar to that of Aredia.

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