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Zometafor the prevention of skeletal related events: safety

Zometa ( Zoledronic acid ) is indicated for the prevention of skeletal related events ( pathological fractures, spinal compression, radiation or surgery to bone, or tumor-induced hypercalcemia ) in patients with multiple myeloma and advanced malignancies involving bone. An intravenous bisphosphonate, Zometa is the only approved therapy to demonstrate efficacy in reducing or delaying bone complications in multiple myeloma and across a broad range of malignancies such as breast, prostate, lung and renal cell cancers in patients with metastatic disease when administered monthly.

Zometa has been associated with reports of renal insufficiency. Patients should be adequately rehydrated and have their serum creatinine assessed prior to receiving each dose of Zometa. Due to the risk of clinically significant deterioration in renal function, single doses of Zometa should not exceed 4 mg and the duration of infusion should be no less than 15 minutes in 100 ml of dilutent. The risk of renal adverse events may be greater in patients with renal insufficiency. Zometa is not recommended for treatment of patients with severe renal impairment.

Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates including Zometa.

Caution is advised when Zometa is used in Aspirin-sensitive patients, or with aminoglycosides, loop diuretics and other potentially nephrotoxic drugs.

Zometa contains the same active ingredient ( Zoledronic acid ) as found in Aclasta. Patients being treated with Zometa should not be treated with Aclasta concomitantly.

Zometa should not be used in patients who are pregnant, or plan to become pregnant, or who are breast-feeding.

In clinical trials, the most commonly reported adverse events included flu-like syndrome ( fever, arthralgias, myalgias, skeletal pain ), fatigue, gastrointestinal reactions, anemia, weakness, cough, dyspnea and edema.

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.

Osteonecrosis of the jaw ( ONJ ) has been reported in patients with cancer receiving treatment including bisphosphonates, chemotherapy, and/or corticosteroids. The majority of reported cases have been associated with dental procedures such as tooth extraction. A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors. While on treatment, these patients should avoid invasive dental procedures if possible. No data are available to suggest whether discontinuation of bisphosphonate therapy reduces the risk of ONJ in patients requiring dental procedures. A causal relationship between bisphosphonate use and osteonecrosis of the jaw has not been established. ( Xagena )

Fonte: FDA, 2010