VISTIDE is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS).THE SAFETY AND EFFICACY OF VISTIDE HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER CMV INFECTIONS (SUCH AS PNEUMONITIS OR GASTROENTERITIS), CONGENITAL OR NEONATAL CMV DISEASE, OR CMV DISEASE IN NON-HIV-INFECTED INDIVIDUALS.
Initiation of therapy with VISTIDE is contraindicated in patients with a serum creatinine > 1.5 mg/dL, a calculated creatinine clearance ? 55 mL/min, or a urine protein ? 100 mg/dL (equivalent to ? 2+ proteinuria).VISTIDE is contraindicated in patients receiving agents with nephrotoxic potential.Such agents must be discontinued at least seven days prior to starting therapy with VISTIDE.VISTIDE is contraindicated in patients with hypersensitivity to cidofovir.VISTIDE is contraindicated in patients with a history of clinically severe hypersensitivity to probenecid or other sulfa-containing medications.Direct intraocular injection of VISTIDE is contraindicated; direct injection of cidofovir has been associated with iritis, ocular hypotony, and permanent impairment of vision.
Dose-dependent nephrotoxicity is the major dose-limiting toxicity related to VISTIDE administration.
Cases of acute renal failure resulting in dialysis and/or contributing to death have occurred with as few as one or two doses of VISTIDE.
Renal function (serum creatinine and urine protein) must be monitored within 48 hours prior to each dose of VISTIDE.
Dose adjustment or discontinuation is required for changes in renal function (serum creatinine and/or urine protein) while on therapy.
Proteinuria, as measured by urinalysis in a clinical laboratory, may be an early indicator of VISTIDE-related nephrotoxicity.
Continued administration of VISTIDE may lead to additional proximal tubular cell injury, which may result in glycosuria, decreases in serum phosphate, uric acid, and bicarbonate, elevations in serum creatinine, and/or acute renal failure, in some cases, resulting in the need for dialysis.
Patients with these adverse events occurring concurrently and meeting a criteria of Fanconi's syndrome have been reported.
Renal function that did not return to baseline after drug discontinuation has been observed in clinical studies of VISTIDE.Intravenous normal saline hydration and oral probenecid must accompany each VISTIDE infusion.
Probenecid is known to interact with the metabolism or renal tubular excretion of many drugs (see PRECAUTIONS).The safety of VISTIDE has not been evaluated in patients receiving other known potentially nephrotoxic agents, such as intravenous aminoglycosides (e.g., tobramycin, gentamicin, and amikacin), amphotericin B, foscarnet, intravenous pentamidine, vancomycin, and non-steroidal anti-inflammatory agents (see DOSAGE AND ADMINISTRATION).