Ganite: Prescribing Information

Prescribing Information: Adverse Reactions

Kidney

Adverse renal effects, as demonstrated by rising BUN and creatinine, have been reported in about 12.5% of patients treated with Ganite. In a controlled clinical trial of patients with cancer-related hypercalcemia, two patients receiving Ganite and one patient receiving calcitonin developed acute renal failure. Due to the serious nature of the patients' underlying conditions, the relationship of these events to the drug was unclear. Ganite should not be administered to patients with serum creatinine >2.5 mg/dL (see CONTRAINDICATIONS and WARNINGS).

Metabolic

Hypocalcemia may occur after Ganite treatment (see PRECAUTIONS).

Transient hypophosphatemia of mild-to-moderate degree may occur in up to 79% of hypercalcemic patients following treatment with Ganite. In a controlled clinical trial, 33% of patients had at least 1 serum phosphorus measurement between 1.5-2.4 mg/dL, while 46% of patients had at least 1 serum phosphorus value <1.5 mg/dL. Patients who develop hypophosphatemia may require oral phosphorus therapy.

Decreased serum bicarbonate, possibly secondary to mild respiratory alkalosis was reported in 40-50% of cancer patients treated with Ganite. The cause for this effect is not clear. This effect has been asymptomatic and has not required specific treatment.

Hematologic

The use of very high doses of gallium nitrate (up to 1400 mg/m²) in treating patients for advanced cancer has been associated with anemia, and several patients have received red blood cell transfusions. Due to the serious nature of the underlying illness, it is uncertain that the anemia was caused by gallium nitrate.

Blood Pressure

A decrease in mean systolic and diastolic blood pressure was observed several days after treatment with gallium nitrate in a controlled clinical trial. The decrease in blood pressure was asymptomatic and did not require specific treatment.

Visual and Auditory

In cancer chemotherapy trials, a small proportion (<1%) of patients treated with multiple high doses of gallium nitrate combined with other investigational anticancer drugs, have developed acute optic neuritis. While these patients were critically ill and had received multiple drugs, a reaction to high-dose gallium nitrate is possible. Most patients had full recovery; however, at least one case of permanent blindness has been reported. One patient with cancer-related hypercalcemia was reported to develop decreased hearing following gallium nitrate administration. Due to the patient's underlying condition and concurrent therapies, the relationship of this event to gallium nitrate administration is unclear. Tinnitus and partial loss of auditory acuity have been reported rarely ( <1%) in patients who received high-dose gallium nitrate as anticancer treatment.

Miscellaneous

Other clinical events reported in association with gallium nitrate treatment for cancer as well as cancer-related hypercalcemia include: nausea and/or vomiting, tachycardia, lethargy, confusion, dreams and hallucinations, diarrhea, constipation, lower extremity edema, hypothermia, fever, dyspnea, rales and rhonchi, anemia, leukopenia, paresthesia, skin rash, pleural effusion, and pulmonary infiltrates. Due to the serious nature of the underlying condition of these patients, the relationship of these events to therapy with gallium nitrate is unknown. A single case of encephalopathy followed rapidly by coma and death has been reported after treatment in a cancer chemotherapy trial with gallium nitrate 300 mg/m²/day for 7 days. Treatment with gallium nitrate other than as described in this labeling may be complicated by adverse events not listed.