Posology : מינונים

4.2    Posology and method of administration
PREVYMIS should be initiated by a physician experienced in the management of patients who have had an allogeneic haematopoietic stem cell transplant.

Posology
The recommended dose of PREVYMIS is one 480 mg tablet once daily.

PREVYMIS should be started after HSCT. PREVYMIS may be started on the day of transplant and no later than 28 days post-transplant. PREVYMIS may be started before or after engraftment. Prophylaxis with PREVYMIS should continue through 100 days post-transplant.


The safety and efficacy of letermovir use for more than 100 days has not been studied in clinical trials. Prolonged letermovir prophylaxis beyond 100 days post-transplant may be of benefit in some patients at high risk for late CMV reactivation (see section 5.1). Use of letermovir prophylaxis for greater than 100 days requires a careful assessment of the benefit-risk balance.

Dose adjustment
If PREVYMIS is co-administered with cyclosporine, the dose of PREVYMIS should be decreased to 240 mg once daily (see sections 4.5 and 5.2).
•     If cyclosporine is initiated after starting PREVYMIS, the next dose of PREVYMIS should be decreased to 240 mg once daily.
•     If cyclosporine is discontinued after starting PREVYMIS, the next dose of PREVYMIS should be increased to 480 mg once daily.
•     If cyclosporine dosing is temporarily interrupted due to high cyclosporine levels, no dose adjustment of PREVYMIS is needed.

Missed dose
Patients should be instructed that if they miss a dose of PREVYMIS, they should take it as soon as they remember. If they do not remember until it is time for the next dose, they should skip the missed dose and go back to the regular schedule. Patients should not double their next dose or take more than the prescribed one.

Special populations

Elderly
No dose adjustment of PREVYMIS is required based on age (see sections 5.1 and 5.2).
Hepatic impairment
No dose adjustment of PREVYMIS is required based on mild (Child-Pugh Class A) to moderate (Child-Pugh Class B) hepatic impairment. PREVYMIS is not recommended for patients with severe (Child-Pugh Class C) hepatic impairment (see section 5.2).

Combined hepatic and renal impairment
PREVYMIS is not recommended in patients with moderate hepatic impairment combined with moderate or severe renal impairment (see section 5.2).

Renal impairment
No dose adjustment of PREVYMIS is recommended for patients with mild, moderate, or severe renal impairment. No dose recommendation can be made for patients with end stage renal disease (ESRD) with or without dialysis. Efficacy and safety has not been demonstrated for patients with ESRD.

Paediatric population
PREVYMIS is not indicated for children and adolescents under 18 years of age.
The safety and efficacy of PREVYMIS in patients below 18 years of age have not been established.
No data are available (see section 5.1).

Method of administration
For oral use.
The tablet should be swallowed whole and may be taken with or without food. The tablet should not be divided, crushed, or chewed.