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Contraindications added after episodes of severe renal toxicity with cidofovir injection


From the November 20, 1996 issue

Cidofovir (Vistide®, formerly HPMPC) was approved by FDA last June to delay progression of AIDS- associated CMV retinitis and help prevent blindness. Although the potential for nephrotoxicity with cidofovir is listed in official product labeling, several reports of severe renal impairment, including at least two cases of acute renal failure resulting in dialysis and/or contributing to death after just one or two doses of Vistide®, have caused the drug's manufacturer, Gilead Sciences, to add new guidelines and contraindications.

The new reports were associated with cidofovir administration to patients with risk factors for nephrotoxicity, including preexisting mild renal insufficiency and administration of the drug soon after completion of aminoglycoside therapy in a patient with normal serum creatinine.

The new guidelines attempt to ensure proper patient selection, and proper administration and monitoring. They include contraindication of therapy initiation in patients with serum creatinine levels above 1.5 mg/dL, creatinine clearance less than 55 mL/min, or urine protein above 100 mg/dL (equivalent to 2+ proteinuria or more). The drug is contraindicated when given with potential nephrotoxic drugs (e.g., foscarnet, amphotericin B, aminoglycoside antibiotics, non-steroidal anti-inflammatory agents, and intravenous pentamidine). Patients should undergo a "washout" period of at least 7 days following the administration of the above agents prior to receiving cidofovir. Other guidelines include the need for IV prehydration with sodium chloride injection, use of probenecid with each infusion, not exceeding the recommended cidofovir dose, monitoring of renal function within 48 hours prior to each dose, and discontinuing the drug or reducing the dose at the earliest sign of renal compromise.

Cidofovir joins ganciclovir (Cytovene®) and foscarnet (Foscavir®), which are also approved for this indication. Both are given by IV infusion. Ganciclovir is also available in an oral form for maintenance treatment, and as an eye implant called Vitrasert®. Cidofovir is also under investigation as an intravitreal formulation. According to the AIDS Treatment Data Network, another CMV product given by direct injection into the eye is ISIS 2922. It is in clinical trials but is available under a compassionate use protocol for patients who are unable to tolerate other treatments. Patients may call The Network at 800 445 3235 for a referral.

Gilead Science and FDA medWatch request that you report any case of nephrotoxicity or other serious toxicity associated with cidofovir administration to 1-800-Gilead-5 or 1-800-FDA-1088/fax 1-800-FDA- 0178. A complete set of guidelines, treatment log, and laboratory monitoring guidelines for use of cidofovir are available from Gilead Sciences.

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