INDICATIONS AND USAGE（适应症）

Adult Patients

Treatment of Cytomegalovirus (CMV) Retinitis: VALCYTE is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS).

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

Pediatric Patients

Prevention of CMV Disease: VALCYTE is indicated for the prevention of CMV disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk.

DOSAGE（服用剂量）

Recommended Dosage in Adult Patients with Normal Renal Function

Treatment of CMV Retinitis:

Induction: The recommended dosage is 900 mg (two 450 mg tablets) taken orally twice a day for 21 days.

Maintenance: Following induction treatment, or in adult patients with inactive CMV retinitis, the recommended dosage is 900 mg (two 450 mg tablets) taken orally once a day.

Prevention of CMV Disease:

For adult patients who have received a heart or kidney-pancreas transplant, the recommended dosage is 900 mg (two 450 mg tablets) taken orally once a day starting within 10 days of transplantation until 100 days post-transplantation.

For adult patients who have received a kidney transplant, the recommended dosage is 900 mg (two 450 mg tablets) taken orally once a day starting within 10 days of transplantation until 200 days post-transplantation.

Recommended Dosage in Pediatric Patients

Prevention of CMV Disease in Pediatric Kidney Transplant Patients: For pediatric kidney transplant patients 4 months to 16 years of age, the recommended once daily mg dose (7 × BSA × CrCl) should start within 10 days of post-transplantation until 200 days post-transplantation.

Prevention of CMV Disease in Pediatric Heart Transplant Patients: For pediatric heart transplant patients 1 month to 16 years of age, the recommended once daily mg dose (7 × BSA × CrCl) should start within 10 days of transplantation until 100 days post-transplantation.

The recommended once daily dosage of VALCYTE is based on body surface area (BSA) and creatinine clearance (CrCl) derived from a modified Schwartz formula, and is calculated using the equation below:

Pediatric Dose (mg) = 7 × BSA × CrCl (calculated using a modified Schwartz formula). If the calculated Schwartz creatinine clearance exceeds 150 mL/min/1.73m2, then a maximum value of 150 mL/min/1.73m2 should be used in the equation.

ADVERSE REACTIONS（不良反应）

Hematologic Toxicity

Acute Renal Failure

Impairment of Fertility

Fetal Toxicity

Mutagenesis and Carcinogenesis

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/dc548ff9-e8ea-4d6e-b9b4-e31f53ac4078/spl-doc?hl=Valcyte

Valcyteinformation