Valcyte 450 mg Tablet

Standard Dosage: Valganciclovir is administered orally, and should be taken with food. Valganciclovir is rapidly and extensively converted into the active ingredient ganciclovir. The bioavailability of ganciclovir from Valganciclovir is up to 10-fold higher than from oral ganciclovir.

The dosage and administration of Valganciclovir tablets or powder for oral solution as described below should be closely followed. The ganciclovir systemic exposure following administration of 900 mg Valganciclovir powder for oral solution is equivalent to a 900 mg Valganciclovir dose administered as two 450 mg tablets.

An oral dosing dispenser with 25 mg graduations up to 500 mg is provided with the powder for oral solution. It is recommended that this dispenser is used to measure and administer the dose.

Treatment of cytomegalovirus (CMV) retinitis-

Adult patients:

• Induction treatment of CMV retinitis: For patients with active CMV retinitis, the recommended dose is 900 mg twice a day for 21 days. Prolonged induction treatment may increase the risk of bone marrow toxicity
• Maintenance treatment of CMV retinitis: Following induction treatment, or in adult patients with inactive CMV retinitis, the recommended dose is 900 mg once daily. Patients whose retinitis worsens may repeat induction treatment. The duration of maintenance treatment should be determined on an individual basis.

Pediatric patients: The safety and efficacy of Valganciclovir in the treatment of CMV retinitis have not been established in adequate and well-controlled clinical studies in pediatric patients.?

Prevention of CMV disease in transplantation-

Adult patients: For kidney transplant patients, the recommended dose is 900 mg once daily starting within 10 days post-transplantation and continuing until 200 days post-transplantation. For patients who have received a solid organ transplant other than kidney, the recommended dose is 900 mg once daily starting within 10 days post-transplantation and continuing until 100 days post-transplantation.

Pediatric patients: In pediatric solid organ transplant patients from birth, who are at risk of developing CMV disease, the recommended once daily dose of Valganciclovir is based on body surface area (BSA) and creatinine clearance (ClCr) derived from Schwartz formula (ClCr), and is calculated using the equation below:

Pediatric dose (mg)= 7 x BSA x ClCr. If the creatinine clearance exceeds 150 ml/min/1.73 m², then a maximum value of 150 ml/min/1.73 m²