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For Healthcare
Professionals
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Warnings
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(See boxed WARNING.) The hypercalcemic state in cancer
patients is commonly associated with impaired renal function. Abnormalitiesin renal function
(elevated BUN and/or serum creatinine) have been observed in clinical trials with Ganite. It is
strongly recommended that serum creatinine be monitored during Ganite therapy. Since patients
with cancer-related hypercalcemia are frequently dehydrated, it is important that such patients be
adequately hydrated with oral and/or intravenous fluids (preferably saline) and that a satisfactory
urine output (a urine output of 2 L/day is recommended) be established before therapy with Ganite
is started. Adequate hydration should be maintained throughout the treatment period, with careful
attention to avoid overhydration in patients with compromised cardiovascular status. Diuretic
therapy should not be employed prior to correction of hypovolemia. Ganite therapy should be
discontinued if the serum creatinine level exceeds 2.5 mg/dL.
The use of Ganite in patients with marked renal insufficiency (serum creatinine > 2.5 mg/dL) has
not been systematically examined. If therapy is undertaken in patients with moderately impaired
renal function (serum creatinine 2.0 to 2.5 mg/dL), frequent monitoring of the patient's renal
status is recommended. Treatment should be discontinued if the serum creatinine level exceeds 2.5
mg/dL.
Combined use of Ganite with other potentially nephrotoxic drugs (e.g., aminoglycosides, amphotericin
B) may increase the risk of developing renal insufficiency in patients with cancer-related
hypercalcemia (See boxed WARNING).
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