Prevymis

Prevymis Dosage/Direction for Use

letermovir

Manufacturer:

Merck Sharp & Dohme

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
PREVYMIS should be initiated by a physician experienced in the management of patients who have had an allogeneic haematopoietic stem cell transplant.
Posology: PREVYMIS is available for oral administration (240 mg film-coated tablets).
PREVYMIS tablets and concentrate for solution for infusion may be used interchangeably at the discretion of the physician, and no dose adjustment is necessary.
The recommended dosage of PREVYMIS is 480 mg 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.
Prolonged letermovir prophylaxis beyond 100 days post-transplant may be of benefit in some patients at high risk for late CMV reactivation (see Pharmacology: Pharmacodynamics under Actions). Use of letermovir prophylaxis for greater than 100 days requires a careful assessment of the benefit-risk balance.
Dosage adjustment: If PREVYMIS is co-administered with cyclosporine, the dosage of PREVYMIS should be decreased to 240 mg once daily (see Interactions and Pharmacology: Pharmacokinetics under Actions).
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 Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
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 Pharmacology: Pharmacokinetics under Actions).
Combined hepatic and renal impairment: PREVYMIS is not recommended in patients with moderate hepatic impairment combined with moderate or severe renal impairment (see Pharmacology: Pharmacokinetics under Actions).
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: The safety and efficacy of PREVYMIS in patients below 18 years of age have not been established. No data are available (see Pharmacology: Pharmacodynamics under Actions).
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.
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