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Basic Drug Info
Drug Name:Vistide
Manufacturer:Gilead Sciences, Inc.
Other Info:© Gilead Sciences, Inc., 2000; all rights reserved.Part Number: RM-1282September 2000



Clinical Trials:


Indications and Usage

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.
cytomegalovirus retinitis -- Infection of the retina by cytomegalovirus characterized by retinal necrosis, hemorrhage, vessel sheathing, and retinal edema. Cytomegalovirus retinitis is a major opportunistic infection in AIDS patients and can cause blindness.

Acquired Immunodeficiency Syndrome -- An acquired defect of cellular immunity associated with infection by the human immunodeficiency virus (HIV), a CD4-positive T-lymphocyte count under 200 cells/microliter or less than 14% of total lymphocytes, and increased susceptibility to opportunistic infections and malignant neoplasms. Clinical manifestations also include emaciation (wasting) and dementia. These elements reflect criteria for AIDS as defined by the CDC in 1993.

Cytomegalovirus Infections -- Infection with CYTOMEGALOVIRUS, characterized by enlarged cells bearing intranuclear inclusions. Infection may be in almost any organ, but the salivary glands are the most common site in children, as are the lungs in adults.

Pneumonia -- Inflammation of any part, segment or lobe, of the lung parenchyma.

Gastroenteritis -- INFLAMMATION of any segment of the GASTROINTESTINAL TRACT from ESOPHAGUS to RECTUM. Causes of gastroenteritis are many including genetic, infection, HYPERSENSITIVITY, drug effects, and CANCER.

Neonatal disorder -- Diseases of newborn infants present at birth (congenital) or developing within the first month of birth. It does not include hereditary diseases not manifesting at birth or within the first 30 days of life nor does it include inborn errors of metabolism. Both HEREDITARY DISEASES and METABOLISM, INBORN ERRORS are available as general concepts.

Disease -- A definite pathologic process with a characteristic set of signs and symptoms. It may affect the whole body or any of its parts, and its etiology, pathology, and prognosis may be known or unknown.

Contraindications

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.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Iritis -- Inflammation of the iris characterized by circumcorneal injection, aqueous flare, keratotic precipitates, and constricted and sluggish pupil along with discoloration of the iris.

Ocular hypotony -- Abnormally low intraocular pressure often related to chronic inflammation (uveitis).

Warnings

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).

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