SESinfo 2-08 10.6.3.indd - Suomen elokuvasäätiö

II. Valcyte ®A. Treatment for CMV RetinitisValcyte ® will be approved based on all of the following criteria:1. Definitive diagnosis of AIDS-AND-2. a. Ophthalmic exam consistent with a diagnosis of CMVretinitis-OR-b. Histological culture or serologic evidence (a negative CMVculture does not rule out CMV retinitis)Authorization for induction therapy (BID dosing) will be issued for 21 days.Authorization for maintenance therapy (QD dosing) will be issued for 1 year.B. Prevention of CMV DiseaseValcyte ® will be approved based on the following criteria:1. Solid organ transplant recipient:KidneyHeartKidney-pancreasAuthorization for solid organ transplant recipients will be issued for 6months.Contraindications and Warnings:Black Box WarningThe clinical toxicity of Cytovene ® include granulocytopenia, anemia, andthrombocytopenia. In animal studies ganciclovir was carcinogenic, teratogenic, and