AREDIA, in conjunction with adequate hydration, is indicated for the treatment of patients with moderate or severe hypercalcemia associated with malignancy, with or without bone metastases.
AREDIA is indicated for the treatment of patients with moderate to severe Paget's disease of bone
AREDIA is indicated, in conjunction with standard antineoplastic therapy, for the treatment of patients with osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma
AREDIA (pamidronate disodium) is contraindicated in patients with clinically significant hypersensitivity to bisphosphonates or any of the excipients in the formulation.
AREDIA (pamidronate disodium) is not recommended in patients with severe renal impairment. Serum creatinine should be measured before each 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. Treatment was resumed only when the creatinine returned to within 10% of the baseline value.
AREDIA (pamidronate disodium) is excreted intact primarily via the kidney, and the risk of renal adverse reactions may be greater in patients with impaired renal function. Patients who receive AREDIA (pamidronate disodium) should have serum creatinine assessed prior to each treatment. In patients receiving AREDIA (pamidronate disodium) for bone metastases, who show evidence of deterioration in renal function, AREDIA (pamidronate disodium) treatment should be withheld until renal function returns to baseline.
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 as to whether discontinuation of bisphosphonate therapy reduces the risk of ONJ in patients requiring dental procedures. A causal relationship between bisphosphonate use and ONJ has not been established.
In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates.
The most common adverse events in bone metastases clinical trials regardless of causality were as follows: Fluid overload, generalized pain, hypertension, abdominal pain, anorexia, constipation, nausea, vomiting, urinary tract infection, bone pain, fever, back pain, arthrosis, headache, anemia, hypocalcemia, arthralgias, myalgias, and dyspnea.
Caution is advised when IV bisphosphonates are administered with potentially nephrotoxic drugs.
Patients should be administered an oral calcium supplement of 500 mg and a multiple vitamin containing 400 IU of vitamin D daily.
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