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Vitrasert

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Vitrasert

INDICATIONS

The Vitrasert (ganciclovir) Implant is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS).

The diagnosis of CMV retinitis is ophthalmologic and should be made by indirect ophthalmoscopy. Other conditions in the differential diagnosis of CMV retinitis include candidiasis, toxoplasmosis, histoplasmosis, retinal scars, and cotton wool spots, any of which may produce a retinal appearance similar to CMV. For this reason, it is essential that the diagnosis of CMV be established by a physician familiar with the retinal presentation of these conditions. The Vitrasert (ganciclovir) Implant is for intravitreal implantation only.

Clinical Trials

In a randomized, controlled parallel group trial conducted between May 1993 and December 1994, treatment with the Vitrasert (ganciclovir) Implant was compared to treatment with intravenous ganciclovir (Cytovene-IV; Roche) in 188 patients with AIDS and newly diagnosed CMV retinitis. Patients randomized to the Cytovene-IV treatment group received Cytovene-IV solution at induction doses (5 mg/kg twice daily) for 14 days, followed by maintenance dosing (5 mg/kg once daily). Based on masked assessment of fundus photographs, the median time to progression was approximately 210 days for the Vitrasert (ganciclovir) Implant treatment group compared to approximately 120 days for the intravenous ganciclovir treatment group.

DOSAGE AND ADMINISTRATION

Each Vitrasert Implant contains a minimum of 4.5 mg of ganciclovir, and is designed to release the drug over a 5 to 8 month period of time. Following depletion of ganciclovir from the Vitrasert (ganciclovir) Implant, as evidenced by progression of retinitis, the Vitrasert (ganciclovir) Implant may be removed and replaced.

Handling and Disposal

Caution should be exercised in handling of the Vitrasert (ganciclovir) Implant in order to avoid damage to the polymer coating on the implant, which may result in an increased rate of drug release from the implant. Thus, the Vitrasert (ganciclovir) Implant should be handled only by the suture tab. Aseptic technique should be maintained at all times prior to and during the surgical implantation procedure.

Because the Vitrasert Implant contains ganciclovir, which shares some of the properties of anti-tumor agents (i.e., carcinogenicity and mutagenicity), consideration should be given to handling and disposal of the Vitrasert (ganciclovir) Implant according to guidelines issued for antineoplastic drugs.

HOW SUPPLIED

The Vitrasert (ganciclovir) Implant is supplied in individual unit boxes in a sterile Tyvek package (NDC 24208-412-01). Store at controlled room temperature, 15 - 30°C (59 - 86°F). Protect from freezing, excessive heat and light.

Revised August 2005. Manufactured for: Bausch & Lomb Incorporated, Rochester, NY 14609 USA. (800) 338-2020. Manufactured by: AMP, Inc. Irvine, CA 92618, USA. FDA Rev date: 4/18/2000

Last reviewed on RxList: 12/2/2008
This monograph has been modified to include the generic and brand name in many instances.

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Additional Vitrasert Information

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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