|Manufacturer:||Novartis Pharmaceuticals Corporation|
The recommended dose of 90 mg should be diluted in 500 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP, and administered over a 4-hour period on a monthly basis.
Aredia must not be mixed with calcium-containing infusion solutions, such as Ringer’s solution, and should be given in a single intravenous solution and line separate from all other drugs.Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.Aredia reconstituted with Sterile Water for Injection may be stored under refrigeration at 2°C-8°C (36°F-46°F) for up to 24 hours.
Aredia, in conjunction with adequate hydration, is indicated for the treatment of moderate or severe hypercalcemia associated with malignancy, with or without bone metastases.
Patients who have either epidermoid or non-epidermoid tumors respond to treatment with Aredia.
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 2 L/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 Aredia in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions has not been established.
Deterioration in Renal FunctionBisphosphonates, including Aredia, have been associated with renal toxicity manifested as deterioration of renal function and potential renal failure.DUE TO THE RISK OF CLINICALLY SIGNIFICANT DETERIORATION IN RENAL FUNCTION, WHICH MAY PROGRESS TO RENAL FAILURE, SINGLE DOSES OF AREDIA SHOULD NOT EXCEED 90 MG (see DOSAGE AND ADMINISTRATION for appropriate infusion durations).
Renal deterioration, progression to renal failure, and dialysis have been reported in patients after the initial or a single dose of Aredia.
Focal segmental glomerulosclerosis (including the collapsing variant) with or without nephrotic syndrome, which may lead to renal failure, has been reported in Aredia-treated patients, particularly in the setting of multiple myeloma and breast cancer.
Some of these patients had gradual improvement in renal status after Aredia was discontinued. Patients who receive Aredia should have serum creatinine assessed prior to each treatment.
Patients treated with Aredia for bone metastases should have the dose withheld if renal function has deteriorated.(See DOSAGE AND ADMINISTRATION.)