盐酸缬更昔洛韦片的获批适应症

Tablet, developed by the Swiss company Roche, is an oral anti-cytomegalovirus infection drug. This product is also the prodrug of ganciclovir. It is an active ganciclovir valine ester. After oral administration, it can be rapidly hydrolyzed into ganciclovir by phosphatase in intestinal and liver cells. Its antiviral spectrum and mechanism of action are similar to ganciclovir, but its bioavailability is significantly higher than that of ganciclovir. Its oral bioavailability is 62.4%, which is 10 times that of ganciclovir, while its toxicity is greatly reduced.

What are its indications?

In May 2001, the U.S. FDA approved the marketing of Valcyte hydrochloride tablets for clinical use in the treatment of acute retinitis caused by CMV infection in patients with acquired immunodeficiency syndrome.

In May 2003, its indications were expanded to include Valcyte for the prevention and treatment of secondary CMV infection in organ transplant recipients.

On August 11, 2010, Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) approved valganciclovir hydrochloride tablets (Valcyte) for the treatment of adult kidney transplant patients at high risk for cytomegalovirus (CMV) disease.

Launched in China in 2006, it is suitable for the treatment of patients with acquired immunodeficiency syndrome (AIDS) combined with cytomegalovirus (CMV) retinitis and the prevention of CMV infection in high-risk solid organ transplant patients.

Special Note: Do not break or crush the tablet. Considering that valganciclovir hydrochloride tablets have potential teratogenic and carcinogenic effects in humans, special caution should be used when handling damaged tablets. Avoid direct contact with skin or mucous membranes with broken or crushed tablets. In the event of contact, flush skin thoroughly with soap and water and eyes with plenty of water.