Valvir-450 Dosage/Direction for Use

Standard dosage in adults: Induction treatment of CMV retinitis: For patients with active CMV retinitis, the recommended dose is 900 mg valganciclovir (two Valganciclovir 450 mg tablets) twice a day for 21 days and, whenever possible, taken with food. Prolonged induction treatment may increase the risk of bone marrow toxicity Maintenance treatment of CMV retinitis: Following induction treatment, or in patients with inactive CMV retinitis, the recommended dose is 900mg valganciclovir (two Valganciclovir 450 mg tablets) once daily and, whenever possible, taken with food. Patients whose retinitis worsens may repeat induction treatment; however, consideration should be given to the possibility of viral drug resistance.
Prevention of CMV disease in solid organ transplantation: For kidney transplant patients, the recommended dose is 900 mg (two Valganciclovir 450 mg tablets) once daily, starting within 10 days of transplantation and continuing until 100 days post-transplantation. Prophylaxis may be continued until 200 days post-transplantation.
For patients who have received a solid organ transplant other than kidney, the recommended dose is 900 mg (two Valganciclovir 450 mg tablets) once daily, starting within 10 days of transplantation and continuing until 100 days post-transplantation.
Whenever possible, the tablets should be taken with food.
Special Dosage Instruction: Patients with renal impairment: Serum creatinine levels or creatinine clearance should be monitored carefully. Dosage adjustment is required according to creatinine clearance, as shown in the table as follows.
An estimated creatinine clearance (ml/min) can be related to serum creatinine by the following formulae: See Equation 2 and Table 6.

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Patients undergoing haemodialysis: For patients on haemodialysis (CrCl < 10 ml/min) a dose recommendation cannot be given. Thus Valganciclovir film-coated tablets should not be used in these patients.
Patients with hepatic impairment: Safety and efficacy of Valganciclovir tablets have not been studied in patients with hepatic impairment.
Paediatric population: The safety and efficacy of Valganciclovir in paediatric patients have not been established in adequate and well-controlled clinical studies.
Elderly patients: Safety and efficacy have not been established in this patient population.
Patients with severe leucopenia, neutropenia, anaemia, thrombocytopenia and pancytopenia; before initiation of therapy.
If there is a significant deterioration of blood cell counts during therapy with Valganciclovir, treatment with haematopoietic growth factors and/or dose interruption should be considered.
Method of administration: Valganciclovir is administered orally, and whenever possible, should be taken with food. Precautions to be taken before handling or administering the medicinal product.
The tablets should not be broken or crushed. Since Valganciclovir is considered a potential teratogen and carcinogen in humans, caution should be observed in handling broken tablets. Avoid direct contact of broken or crushed tablets with skin or mucous membranes. If such contact occurs, wash thoroughly with soap and water, rinse eyes thoroughly with sterile water, or plain water if sterile water is unavailable.