Valganciclovir is indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS) and for the prevention of CMV infection in high-risk solid organ transplant patients.
Dosage and Administration
Caution: The fundamental requirement to avoid overdosage is strict administration according to the recommended dosage.
Standard Dosage
Valganciclovir is administered orally and should be taken with food (see Pharmacokinetic Properties – Absorption).Valganciclovir hydrochloride tablets are rapidly and extensively converted to ganciclovir. The bioavailability of valganciclovir, measured as ganciclovir, is approximately 10-fold higher than that of ganciclovir capsules. Therefore, the dosage and administration instructions for valganciclovir described below must be strictly followed (see Warnings and Precautions and Overdosage).
Adult Patients
Induction Therapy for 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 myelotoxicity (see Warnings and Precautions).
Maintenance Therapy for CMV Retinitis
Following induction therapy, or in patients with inactive CMV retinitis, the recommended dose is 900 mg (two 450 mg tablets) once daily.Patients with progression of retinitis may be re-treated with induction therapy (see Induction Therapy).
Prophylaxis of CMV Infection in Transplant Patients
Renal transplant patients: The recommended dose is 900 mg (two 450 mg tablets) once daily, starting within 10 days after transplantation and continuing until 200 days post-transplant.
Solid organ transplant patients other than renal: The recommended dose is 900 mg (two 450 mg tablets) once daily, starting within 10 days after transplantation and continuing until 100 days post-transplant.
Special Dosage Guidelines
Renal Impairment
Serum creatinine or creatinine clearance (CrCl) should be closely monitored. For adult patients, dosage should be adjusted according to creatinine clearance as shown in the table below (see Pharmacokinetics in Special Populations and Warnings and Precautions).
Table 1: Dosage Adjustment for Valganciclovir Tablets in Patients with Renal Impairment
1.CrCl (mL/min) ≥60: Induction dose 900 mg twice daily; Maintenance / Prophylaxis dose 900 mg once daily
2.CrCl (mL/min) 40–59: Induction dose 450 mg twice daily; Maintenance / Prophylaxis dose 450 mg once daily
3.CrCl (mL/min) 25–39: Induction dose 450 mg once daily; Maintenance / Prophylaxis dose 450 mg every 2 days
4.CrCl (mL/min) 10–24: Induction dose 450 mg every 2 days; Maintenance / Prophylaxis dose 450 mg twice weekly
5.CrCl (mL/min) <10: Not recommended for induction; Not recommended for maintenance / prophylaxis
