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Precautions |
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GeneralAsymptomatic or mild to moderate hypocalcemia (6.5-8.0 mg/dL, corrected for serum albumin) occurred in approximately 38% of patients treated with Ganite in the controlled clinical trial. One patient exhibited a positive Chvostek's sign. If hypocalcemia occurs, Ganite therapy should be stopped and short-term calcium therapy may be necessary. |
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Laboratory TestsRenal function (serum creatinine and BUN) and serum calcium must be closely monitored during Ganite therapy. In addition to baseline assessment, the suggested frequency of calcium and phosphorus determinations is daily and twice weekly, respectively. Ganite should be discontinued if the serum creatinine exceeds 2.5 mg/dL. |
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Drug InteractionsThe concomitant use of highly nephrotoxic drugs in combination with Ganite may increase the risk for development of renal insufficiency (See WARNINGS). Available information does not indicate any adverse interaction with diuretics such as furosemide. A symptom complex of dyspnea (associated with interstitial pneumonitis in some instances), mouth soreness, and asthenia has been reported in a small number of multiple myeloma patients receiving low dose (40 mg) gallium nitrate subcutaneously in addition to oral cyclophosphamide and prednisone. The serious nature of the underlying condition of these patients precludes a precise understanding of the relationship of these events to either gallium nitrate treatment alone or with cyclophosphamide. |
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Carcinogenesis, Mutagenesis, Impairment of FertilityLong-term studies in animals have not been performed to evaluate the carcinogenic potential of gallium nitrate. Gallium nitrate is not mutagenic in standard tests (i.e., Ames test and chromosomal aberration studies on human lymphocytes). |
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Usage in PregnancyPregnancy Category C. Animal reproduction studies have not been conducted with gallium nitrate. It is also not known whether gallium nitrate can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Ganite should be administered to a pregnant woman only if clearly needed. |
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Nursing MothersIt is not known whether gallium nitrate is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from gallium nitrate, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. |
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Pediatric UseThe safety and effectiveness of Ganite in children have not been established. |
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