VALCYTE TABLET 450 MG [SIN12393P]

Product Info

VALCYTE TABLET 450 MG

[SIN12393P]

2.1 Therapeutic Indications
Valcyte tablets are indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS).

Valcyte is indicated for the prevention of cytomegalovirus (CMV) disease in kidney, heart, and kidney-pancreas transplant patients at high risk. (Donor CMV seropositive/ Recipient CMV seronegative [(D+/R-)]).

Valcyte is not indicated for use in liver transplant patients.

The safety and efficacy of Valcyte for the prevention of CMV disease in other solid organ transplant patients such as lung transplant patients have not been established.

2.2. Dosage and administration
Caution – Strict adherence to dosage recommendations is essential to avoid overdose. Valcyte tablets cannot be substituted for ganciclovir tablets on a one-to-one basis.

2.2.1 Standard Dosage
Valcyte is administered orally, and should be taken with food (see Pharmacokinetics in Special Populations, 3.2.1 Absorption – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). After oral administration, Valcyte is rapidly and extensively converted into ganciclovir. The bioavailability of ganciclovir from Valcyte is up to 10-fold higher than from ganciclovir capsules. Therefore the dosage and administration of Valcyte tablets as described below should be closely followed (see 2.4 Special Warnings and Special Precautions for Use and 2.7 Overdosage – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

For the treatment of CMV retinitis in patients with normal renal function
Adults
Induction
For patients with active CMV retinitis, the recommended dose is 900 mg (two 450 mg tablets) twice a day for 21 days. Prolonged induction treatment may increase the risk of bone marrow toxicity (see section 2.4 Special Warnings and Special Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Maintenance:
Following induction treatment, or in patients with inactive CMV retinitis, the recommended dose is 900 mg (two 450 mg tablets) once daily with food. Patients whose retinitis worsens may repeat induction treatment (see Induction – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The duration of maintenance treatment should be determined on an individual basis.

For the prevention of CMV disease in heart, kidney, and kidney-pancreas transplantation
For kidney transplant patients, the recommended dose is 900 mg (two 450 mg tablets) once daily with food starting within 10 days post-transplantation and continuing until 100 days post-transplantation. Prophylaxis may be continued until 200 days post-transplantation (See 2.4 Special Warnings and Special Precautions for Use, 2.6 Undesirable Effects and 3.1.2 Efficacy/Clinical Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

For patients who have received a heart, or kidney-pancreas transplant, the recommended dose is 900 mg (two 450 mg tablets) once daily with food starting within 10 days post-transplantation and continuing until 100 days post-transplantation.

2.2.2 Special dosage instructions
Geriatric Use
Safety and efficacy have not been established in this patient population. No studies have been conducted in adults older than 65 years of age. Since renal clearance decreases with age, Valcyte should be administered to elderly patients with special consideration of their renal status (see Table 1 and section 3.2.5 Pharmacokinetics in special populations, Geriatric Population – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patients with renal impairment
Serum creatinine or estimated creatinine clearance levels should be monitored carefully. Dosage adjustment is required according to creatinine clearance as shown in the table below (see 3.2.5 Pharmacokinetics in special populations and 2.4 Special Warnings and Special Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Estimated creatinine clearance can be calculated from serum creatinine by the following formula:

Patients undergoing hemodialysis
For patients on hemodialysis (CrCl < 10 ml/min) a dose recommendation cannot be given. Thus Valcyte should not be used in these patients (see 3.2.5 Pharmacokinetics in special populations and 2.4 Special Warnings and Special Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment
The safety and efficacy of Valcyte have not been established in patients with hepatic impairment (see section 3.2.5 Pharmacokinetics in special populations, Hepatic Impairment – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Children
Safety and efficacy have not been established in this patient population. The use of Valcyte in children is not recommended because the pharmacokinetic characteristics of Valcyte have not been established in this patient population (see 2.4 Special Warnings and Special Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

2.3 Contraindications
Valcyte is contraindicated in patients with known hypersensitivity to valganciclovir, ganciclovir or to any of the excipients.

Due to the similarity of the chemical structure of Valcyte and that of aciclovir and penciclovir, a cross-hypersensitivity reaction between these drugs is possible.