PREVYMIS Film-coated tablet Ref.[8782] Active ingredients: Letermovir

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 also available as concentrate for solution for infusion (240 mg and 480 mg).

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 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.

Dosage adjustment

If PREVYMIS is co-administered with cyclosporine, the dosage 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

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.

There is no experience with human overdose with PREVYMIS. During Phase 1 clinical trials, 86 healthy subjects received doses ranging from 720 mg/day to 1440 mg/day of PREVYMIS for up to 14 days. The adverse reaction profile was similar to that of the clinical dose of 480 mg/day. There is no specific antidote for overdose with PREVYMIS. In case of overdose, it is recommended that the patient be monitored for adverse reactions and appropriate symptomatic treatment instituted.

It is unknown whether dialysis will result in meaningful removal of PREVYMIS from systemic circulation.

Shelf life: 30 months.

This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from moisture.

240 mg film-coated tablets: Polyamide/Aluminium/PVC – Aluminium blister card. Each carton contains four (4) cardboard cards, each containing a 7-count blister card for a total of 28 tablets.

480 mg film-coated tablets: Polyamide/Aluminium/PVC – Aluminium blister cards. Each carton contains four (4) cardboard, each containing a 7-count blister card for a total of 28 tablets.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.