Valvir-450 Adverse Reactions

Valganciclovir is a prodrug of ganciclovir, which is rapidly and extensively metabolised to ganciclovir after oral administration. The undesirable effects known to be associated with ganciclovir use can be expected to occur with valganciclovir. All of the undesirable effects observed with valganciclovir clinical studies have been previously observed with ganciclovir. The most commonly reported adverse drug reactions following administration of valganciclovir in adults are neutropenia, anaemia and diarrhoea.
Valganciclovir is associated with a higher risk of diarrhoea compared to intravenous ganciclovir. In addition, valganciclovir is associated with a higher risk of neutropenia and leucopenia compared to oral ganciclovir.
Severe neutropenia (< 500 ANC/µl) is seen more frequently in CMV retinitis patients undergoing treatment with valganciclovir than in solid organ transplant patients receiving valganciclovir.
The frequency of adverse reactions reported in clinical trials with either valganciclovir, oral ganciclovir, or intravenous ganciclovir is presented in the table as follows. The adverse reactions listed were reported in clinical trials in patients with AIDS for the induction or maintenance treatment of CMV retinitis, or in liver, kidney or heart transplant patients for the prophylaxis of CMV disease. The term (severe) in parenthesis in the table indicates that the adverse reaction has been reported in patients at both mild/moderate intensity and severe/life-threatening intensity at that specific frequency.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. (See Table 7.)

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Severe thrombocytopenia may be associated with potentially life-threatening bleeding.
Paediatric population: There are very limited paediatric data on the exposure to valganciclovir. The following table provides a summary of all adverse events which occurred in more than 10% (very common) of the total paediatric population on treatment: See Table 8.

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