Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links

Drugs

-

Valganciclovir (marketed as Valcyte) Information

Valcyte (valganciclovir) is indicated for:

Adult Patients

Treatment of Cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS).
Prevention of CMV disease in kidney, heart, or kidney-pancreas transplant patients at high risk.

Pediatric Patients

Prevention of CMV disease in kidney or heart transplant patients at high risk.

To report any serious adverse events associated with the use of this drug, please contact the FDA MedWatch program using the contact information at the bottom of this page.

-

Related Information

FDA Drug Safety Podcast for Healthcare Professionals: New dosing recommendations to prevent potential Valcyte (valganciclovir) overdose in pediatric transplant patients
9/16/2010
FDA Drug Safety Communication: New dosing recommendations to prevent potential Valcyte (valganciclovir) overdose in pediatric transplant patients
9/15/2010
FDA issues new dosing guide for children using Valcyte [ARCHIVED]
9/15/2010 - FDA Note To Correspondents

-

-

Labeling and Regulatory History from Drugs@FDA

Valganciclovir Hydrochloride (marketed as Valcyte) Prescribing and Label Information

-

Contact FDA

1-800-332-1088

1-800-FDA-0178 Fax

Report a Serious Problem

MedWatch Online

Regular Mail: Use postage-paid FDA Form 3500

Mail to: MedWatch 5600 Fishers Lane

Rockville, MD 20857

-

-