|
|
For Healthcare
Professionals
|
|
|
|
|
Adverse Events
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 concentration
> 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 concentration, possibly secondary to mild respiratory alkalosis,
was reported in 40% to 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 gallium
nitrate have developed acute optic neuritis. For most cases, patients either received
gallium nitrate in combination with another drug that has reported cases of optic neuritis or
gallium nitrate was administered at higher doses. 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, encephalopathy, 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
monograph may be complicated by adverse events not listed.
|
|
|
|
