valcyte上市的时间

It is a pink oval film-coated oral tablet. The main ingredient of valcyte is valganciclovir hydrochloride. So when did Wansaiwei go on the market?

In May 2001, the US FDA approved the market. Valcyte is clinically used to treat acute retinitis caused by CMV infection in patients with acquired immunodeficiency syndrome. In May 2003, its indications were expanded. Valcyte is used to prevent and treat 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 valcyte for the treatment of adult kidney transplant patients at high risk for cytomegalovirus (CMV) disease.

Valcyte is the prodrug of ganciclovir. Valcyte is well absorbed from the gastrointestinal tract and rapidly metabolized into ganciclovir in the small intestinal wall and liver. The absolute bioavailability of ganciclovir converted from valganciclovir is approximately 60%. The systemic exposure of valcyte is small and transient. The 24-hour area under the curve AUC24 and peak concentration (Cmax) are only 1% and 3% of ganciclovir respectively. The proportional relationship between the oral dose of valcyte 450-2625 mg and the AUC of ganciclovir was only studied in the postprandial condition. valcyte When the recommended dose of 900 mg of valcyte was taken with food, the mean AUC24 and Cmax of ganciclovir were increased by approximately 30% and approximately 14%, respectively. Therefore, it is recommended to take valcyte with food.

Induction therapy of CMV retinitis: For patients with active CMV retinitis, the recommended dose is 900 mg (two 450 mg tablets) twice daily for 21 days. Prolonged induction therapy may increase the risk of bone marrow toxicity. Maintenance treatment of CMV retinitis: After induction therapy, or in patients with inactive CMV retinitis, the recommended dose is 900 mg (two 450 mg tablets) once daily. Induction therapy may be repeated in patients with worsening retinitis. Prevention of CMV infection in transplant patients: For patients who have received solid organ transplants, the recommended dose is 900 mg (two 450 mg tablets) once daily, starting within 10 days after transplantation and continuing until 100 days after transplantation.