Rx Update: July 2001

Valganciclovir

Mary Ross, R.Ph., M.B.A.
Peer Review Status: Internally Reviewed

Valganciclovir (Valcyte®), an oral prodrug of ganciclovir, has recently been approved by the FDA for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS). Valganciclovir is indicated for both induction and maintenance therapy in the treatment of CMV retinitis. It offers the advantage of being the first oral drug to be approved for induction treatment of CMV retinitis in AIDS patients.

Adverse events known to occur with ganciclovir can also be expected with valganciclovir, since it is rapidly converted to ganciclovir after oral administration. Valganciclovir's labeling, like ganciclovir's, carries a black-box warning on the risks of granulocytopenia, anemia, and thrombocytopenia. Other adverse events reported with valganciclovir in clinical trials include diarrhea, pyrexia, nausea, headache, vomiting, insomnia, abdominal pain, retinal detachment, peripheral neuropathy, and paresthesia. Adverse events occurred at similar rates when oral valganciclovir was compared to intravenous ganciclovir.

Valganciclovir tablets are administered orally and should be taken with food. In patients with normal renal function, the recommended dose for induction therapy is 900 mg twice daily for 21 days with food. The maintenance dose following induction treatment, or in patients with inactive CMV retinitis, is 900 mg once daily with food. The dose of valganciclovir should be reduced in patients with decreased renal function. Valganciclovir is available as 450 mg tablets.

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