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IMPACT Study Demonstrates That Longer Prophylactic Therapy With Valcyte(R) (Valganciclovir Hydrochloride Tablets) Increases Protection Against CMV - the Most Serious Viral Infection Affecting Transplant Patients
Date:2/13/2009

mal studies, ganciclovir was carcinogenic, teratogenic, and caused aspermatogenesis.

Valcyte tablets should not be administered if the absolute neutrophil count is less than 500 cells/micro liter, the platelet count is less than 25,000/micro liter, or the hemoglobin is less than 8 g/dL. Severe leucopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, bone morrow depression, and aplastic anemia have been observed in patients treated with Valcyte tablets (and ganciclovir). Other adverse events reported with frequency of greater or equal to 5% included diarrhea, tremors, graft rejection, nausea, headache, insomnia, hypertension, vomiting, and fever.

In liver transplant patients, there was a significantly higher incidence of tissue-invasive CMV disease in the Valcyte-treated group compared with oral ganciclovir group.

Strict adherence to dosage recommendations is essential to avoid overdose. Dose modifications are required for patients with renal impairment.

Prescribing information for Valcyte is available at www.rocheusa.com/products/valcyte or www.rochetransplant.com.

About CMV

CMV belongs to the family of herpes viruses and, as such, is very common among the general population. It is estimated that 50-80% of all adults have been infected with the CMV virus. In the majority of cases the virus lies dormant in the body throughout life, but can be reactivated at times when the immune system is weakened (e.g., transplant patients, AIDS patients and premature infants). CMV is the most important serious infection complicating solid organ transplantation. Transplant patients may already be infected with CMV prior to transplantation or receive a donor organ infected with CMV.

CMV infection usually develops during the firs
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SOURCE Roche
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