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(Valcyte) is an oral anti-cytomegalovirus infection drug developed by the Swiss company Roche. It was approved by the US FDA in May 2001. 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 valganciclovir hydrochloride tablets (Valcyte) for the treatment of adult kidney transplant patients at high risk for cytomegalovirus (CMV) disease.

Roche announced on August 31, 2009 that the U.S. Food and Drug Administration (FDA) has approved Valcyte (trade name: Valcyte; generic name: valganciclovir hydrochloride) for the prevention of cytomegalovirus (CMV) infection in pediatric kidney and heart transplant patients aged 4 months to 16 years. Such children are considered to be a high-risk group for CMV infection.

1. Induction treatment of CMV retinitis: For patients with active CMV retinitis, the recommended dose is 900 mg (two 450 mg tablets) twice a day for 21 days. Prolonged induction therapy may increase the risk of bone marrow toxicity. 2. Maintenance treatment of CMV retinitis: After induction therapy, or for 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. 3. Prevention of CMV infection in transplant patients: For kidney transplant patients, the recommended dose of Valcyte is 900 mg (two 450 mg tablets), once a day, starting within 10 days after transplantation until 200 days after transplantation. For patients who have received a solid organ transplant other than a kidney, 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. 

Contraindications: This product should not be used in patients with a known allergic reaction to valganciclovir, ganciclovir or any other component of the drug. Due to the similar chemical structures of valganciclovir hydrochloride tablets to aciclovir and valaciclovir, there may be cross-allergic reactions between these drugs.