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What is ZOMETA®?
ZOMETA® is not chemotherapy. ZOMETA® belongs to a class of drugs called bisphosphonates that are used to reduce or delay complications from bone metastases or bone lesions from multiple myeloma. These drugs reduce the "wearing away" of bone and slow the abnormal buildup of unstable bone.
What is the indication for ZOMETA®?
ZOMETA® (zoledronic acid) injection is indicated for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy.
ZOMETA® (zoledronic acid) injection is indicated for the treatment of hypercalcemia of malignancy.
Vigorous saline hydration, an integral part of hypercalcemia therapy, should be initiated promptly and an attempt should be made to restore the urine output to about 2L/ day throughout treatment. Mild or asymptomatic hypercalcemia may be treated with conservative measures (i.e., saline hydration, with or without loop diuretics). Patients should be hydrated adequately throughout the treatment, but overhydration, especially in those patients who have cardiac failure, must be avoided. Diuretic therapy should not be employed prior to correction of hypovolemia. The safety and efficacy of ZOMETA® in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions has not been established.
How is ZOMETA® given?
ZOMETA® is given by intravenous infusion. It can be administered in your doctor's office, a clinic, or hospital as outpatient therapy. The infusion takes at least 15 minutes. ZOMETA® is administered every 3 to 4 weeks.
How effective is ZOMETA®?
ZOMETA® was tested in three large studies involving over 3,000 patients. These patients all had bone metastases from solid tumors (breast, prostate, lung, kidney cancer, genitourinary cancer, bladder cancer, colorectal cancer, other gastrointestinal cancers, liver cancer, head and neck cancer, malignant melanoma, sarcoma, and others) or multiple myeloma. They were all receiving chemotherapy or hormonal therapy. In these studies, patients who were given ZOMETA® had fewer bone complications, a longer time until bone complications occurred, and a lower risk of developing bone complications, than patients who did not take ZOMETA®.
"Zoledronic Acid is a generic drug used to reduce or delay complications from bone metastases or bone lesions from multiple myeloma.. It is manufactured by licensed generic manufacturers. This product DOES NOT originate from Novartis and IS NOT authorized by Novartis, the owner and maker of the branded Zometa prescription pharmaceutical product."
The most common adverse events (= 15%) in bone metastases clinical trails regardless of causality with ZOMETA® 4 mg (n=1099) were as follows:
Bone pain (53%) Weakness (21%)
Nausea (43%) Myalgia (21%)
Fatigue (36%) Anorexia (20%)
Vomiting (30%) Cough (19%)
Pyrexia (30%) Lower-limb edema (19%)
Anemia (29%) Headache (18%)
Constipation (28%) Arthralgia (18%)
Dyspnea (24%) Malignant Neoplasm Aggravated (15%)
Please see full prescribing information.
ZOMETA® is indicated for patients with multiple myeloma and documented bone metastases from solid tumors in conjunction with standard antineoplastic therapy; prostate cancer should have progressed after treatment with at least one hormonal therapy.
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®.
Patients should be administered an oral calcium supplement of 500 mg and a multiple vitamin containing 400 IU of vitamin D daily.
Due to the risk of clinically significant deterioration in renal function, which may progress to renal failure, single doses of ZOMETA® should not exceed 4 mg and the duration of infusion should be no less than 15 minutes. Risk factors for the deterioration of renal function include elevated baseline creatinine and multiple cycles of bisphosphonate treatment.
ZOMETA® is not recommended in patients with bone metastases with severe renal impairment. Serum creatinine should be measured before each ZOMETA® dose and treatment should be withheld for renal deterioration. In the clinical studies, patients with serum creatinine > 3.0 mg/dL were excluded, renal deterioration was defined as an increase of 0.5 mg/dL for patients with normal baseline creatinine and an increase of 1.0 mg/dL for patients with abnormal baseline creatinine. ZOMETA® treatment was resumed only when the creatinine returned to within 10% of the baseline value.
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 is available as to whether discontinuation of bisphosphonates therapy reduces the risk of ONJ in patients requiring dental procedures.
Caution is advised when bisphosphonates are administered with aminoglycosides, loop diuretics, and potentially nephrotoxic drugs. ZOMETA® should be used with caution in patients with aspirin-sensitive asthma.
ZOMETA® should not be used during pregnancy. Women of childbearing potential should be advised to avoid becoming pregnant. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.