HSCT: Adult and Pediatric Patients 12 Years of Age and Older and Weighing at least 30 kg
The recommended dosage of PREVYMIS is 480 mg administered orally or intravenously once daily. When PREVYMIS is administered orally, the recommended dosage is one 480 mg tablet once daily or two 240 mg tablets once daily. Four 120 mg packets of oral pellets once daily can be used for patients who cannot swallow tablets [see Dosage and Administration (2.9)]. For preparation and administration instructions of intravenous dosing refer to instructions in subsection 2.10 [see Dosage and Administration (2.10)]. For pediatric patients less than 12 years of age or weighing less than 30 kg, refer to weight-based dosing in Table 1 and Table 2 [see Dosage and Administration (2.5)].
Initiate PREVYMIS between Day 0 and Day 28 post-HSCT (before or after engraftment) and continue through Day 100 post-HSCT. In patients at risk for late CMV infection and disease, PREVYMIS may be continued through Day 200 post-HSCT [see Clinical Studies (14.2)].
Dosage of PREVYMIS should be adjusted when co-administered with cyclosporine [see Dosage and Administration (2.4)].
Kidney Transplant: Adult and Pediatric Patients 12 Years of Age and Older and Weighing at least 40 kg
The recommended dosage of PREVYMIS is 480 mg administered orally or intravenously once daily. When PREVYMIS is administered orally, the recommended dosage is one 480 mg tablet once daily or two 240 mg tablets once daily. Four 120 mg packets of oral pellets once daily can be used for patients who cannot swallow tablets [see Dosage and Administration (2.9)]. For preparation and administration instructions of intravenous dosing refer to instructions in subsection 2.10 [see Dosage and Administration (2.10)].
Initiate PREVYMIS between Day 0 and Day 7 post-transplant and continue through Day 200 post-transplant.
Dosage of PREVYMIS should be adjusted when co-administered with cyclosporine [see Dosage and Administration (2.4)].