ascular compromise, bleomycin, vinblastine, hypomagnesemia, or a combination of any of these factors.
Serum Electrolyte Disturbances
Hypomagnesemia, hypocalcemia, hyponatremia, hypokalemia, and hypophosphatemia have been reported to occur in patients treated with PLATINOL-AQ and are probably related to renal tubular damage. Tetany has been reported in those patients with hypocalcemia and hypomagnesemia. Generally, normal serum electrolyte levels are restored by administering supplemental electrolytes and discontinuing PLATINOL-AQ.
Inappropriate antidiuretic hormone syndrome has also been reported.
Hyperuricemia
Hyperuricemia has been reported to occur at approximately the same frequency as the increases in BUN and serum creatinine.
It is more pronounced after doses greater than 50 mg/m2, and peak levels of uric acid generally occur between 3 to 5 days after the dose. Allopurinol therapy for hyperuricemia effectively reduces uric acid levels.
Neurotoxicity
See WARNINGS.
Neurotoxicity, usually characterized by peripheral neuropathies, has been reported. The neuropathies usually occur after prolonged therapy (4 to 7 months); however, neurologic symptoms have been reported to occur after a single dose. Although symptoms and signs of PLATINOL-AQ neuropathy usually develop during treatment, symptoms of neuropathy may begin 3 to 8 weeks after the last dose of PLATINOL-AQ. PLATINOL-AQ therapy should be discontinued when the symptoms are first observed. The neuropathy, however, may progress further even after stopping treatment. Preliminary evidence suggests peripheral neuropathy may be irreversible in some patients. Elderly patients may be more susceptible to peripheral neuropathy (see PRECAUTIONS: Geriatric Use).
Lhermitte's sign, dorsal column myelopathy, and autonomic neuropathy have also been reported.
Loss of taste, seizures, leukoencephalopathy, and reversible posterior leukoencephalopathy syndrome (RPLS) have also been reported.
Muscle cramps, defined as localized, painful, involuntary skeletal muscle contractions of sudden onset and short duration, have been reported and were usually associated in patients receiving a relatively high cumulative dose of PLATINOL-AQ and with a relatively advanced symptomatic stage of peripheral neuropathy.
Ocular Toxicity
Optic neuritis, papilledema, and cerebral blindness have been reported in patients receiving standard recommended doses of PLATINOL-AQ. Improvement and/or total recovery usually occurs after discontinuing PLATINOL-AQ. Steroids with or without mannitol have been used; however, efficacy has not been established.
Blurred vision and altered color perception have been reported after the use of regimens with higher doses of PLATINOL-AQ or greater dose frequencies than recommended in the package insert. The altered color perception manifests as a loss of color discrimination, particularly in the blue-yellow axis. The only finding on funduscopic exam is irregular retinal pigmentation of the macular area.
Anaphylactic-Like Reactions
Anaphylactic-like reactions have been reported in patients previously exposed to PLATINOL-AQ. The reactions consist of facial edema, wheezing, tachycardia, and hypotension within a few minutes of drug administration. Reactions may be controlled by intravenous epinephrine with corticosteroids and/or antihistamines as indicated. Patients receiving PLATINOL-AQ should be observed carefully |
