Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
PREVYMIS is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult and paediatric patients weighing at least 5 kg who are CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT).
PREVYMIS is indicated for prophylaxis of CMV disease in CMV-seronegative adult and paediatric patients weighing at least 40 kg who have received a kidney transplant from a CMV-seropositive donor [D+/R-].
Consideration should be given to official guidance on the appropriate use of antiviral agents.
Letermovir should be initiated by a physician experienced in the management of patients who have had an allogeneic haematopoietic stem cell transplant or kidney transplant.
Letermovir is also available as film -coated tablets (240 mg and 480 mg) and as concentrate for solution for infusion (240 mg and 480 mg).
Letermovir tablets, granules in sachet, and concentrate for solution for infusion may be used interchangeab ly at the discretion of the physician. Dose adjustment may be necessary for paediatric patients weighing less than 30 kg when switching between oral and intravenous formulations. Refer to the prescribing information for the letermovir concentrate for solution for infusion for dosing information.
Letermovir should be started after HSCT. Letermovir may be started on the day of transplant and no later than 28 days post-HSCT. Letermovir may be started before or after engraftment. Prophylaxis with letermovir should continue through 100 days post-HSCT.
Prolonged letermovir prophylaxis beyond 100 days post-HSCT may be of benefit in some patients at high risk for late CMV reactivation (see section 5.1). The safety and efficacy of letermovir use for more than 200 days has not been studied in clinical trials.
The recommended dose of letermovir is 480 mg once daily that can be administered as four 120 mg sachets.
If letermovir is co-administered with cyclosporine, the dose of letermovir should be decreased to 240 mg once daily (see sections 4.5 and 5.2).
The recommended doses of letermovir for paediatric patients weighing less than 30 kg are shown in Table 1 (see also section 5.2). Letermovir should be administered once daily.
Letermovir film-coated tablets can be used for patients who can swallow tablets. Refer to the prescribing information for letermovir film-coated tablet dosing information.
If oral letermovir is co-administered with cyclosporine, the dose of letermovir should be decreased as shown in Table 1 (see also sections 4.5 and 5.2).
Table 1. Recommended dose of letermovir granules in sachet without or with cyclosporine in paediatric patients weighing less than 30 kg:
| Body weight | Administered without cyclosporine | Co-administered with cyclosporine | ||
|---|---|---|---|---|
| Daily oral dose | Number of letermovir sachets once daily | Daily oral dose | Number of letermovir sachets once daily | |
| 15 kg to less than 30 kg | 240 mg | Two 120 mg sachets | 120 mg | One 120 mg sachet |
| 7.5 kg to less than 15 kg | 120 mg | One 120 mg sachet | 60 mg | Three 20 mg sachets |
| 5 kg to less than 7.5 kg | 80 mg | Four 20 mg sachets | 40 mg | Two 20 mg sachets |
Letermovir s hould be started on the day of transplant and no later than 7 days post-kidney transplant and continued through 200 days post-transplant.
The recommended dose of letermovir is 480 mg once daily that can be administered as four 120 mg sachets.
If letermovir is co-administered with cyclosporine, the dose of letermovir should be decreased to 240 mg once daily (see sections 4.5 and 5.2).
Patients should be instructed that if they miss a dose of letermovir, 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 dose.
No dose adjustment of letermovir is required based on age (see sections 5.1 and 5.2).
No dose adjustment of letermovir is required based on mild (Child-Pugh Class A) to moderate (Child-Pugh Class B) hepatic impairment. Letermovir is not recommended for patients with severe (Child-Pugh Class C) hepatic impairment (see section 5.2).
Letermovir is not recommended in patients with moderate hepatic impairment combined with moderate or severe renal impairment (see section 5.2).
No dose adjustment of letermovir 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.
The safety and efficacy of letermovir in HSCT patients weighing less than 5 kg or in kidney transplant patients weighing less than 40 kg have not been established. No data are available. No recommendation on posology for kidney transplant patients weighing less than 40 kg could be supported by pharmacokinetic/pharmacodynamic extrapolation.
For oral use (by ingestion or via an enteral feeding tube).
Administer letermovir granules orally mixed with 1 to 3 teaspoons of soft food or via nasogastric tube (NG tube) or gastric tube (G tube) (see section 6.6). Do not crush or chew because these methods have not been studied. Additional food or a meal can be consumed following administration.
There is no experience with human overdose with letermovir. During Phase 1 clinical trials, 86 healthy adult subjects received doses ranging from 720 mg/day to 1 440 mg/day of letermovir 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 letermovir. 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 letermovir from systemic circulation.
3 years.
This medicinal product does not require any special storage conditions.
Sachets consisting of Polyethylene terephthalate (PET)/Aluminum Foil/Linear low-density polyethylene (LLDPE) Each carton contains 30 sachets.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
PREVYMIS granules are administered orally mixed with soft food or via NG tube or G tube.
See Instructions for Use for details on the preparation and administration of PREVYMIS granules mixed with soft food.
See Instructions for Use, Table 11 (NG tube) and Table 12 (G tube) for details on the preparation and administration of PREVYMIS granules via NG tube or G tube.
Table 11. Recommendations for administration of PREVYMIS granules in sachet via NG tube:
| Dose | NG tube* | Liquid type | Syringe type† | Mixing container | Initial volume (mL) | Rinse volume (mL) |
|---|---|---|---|---|---|---|
| 120 mg to 480 mg | Any ≥8 Fr NG tube | Milk, apple juice, formula, or water | Appropriately sized ENFit or catheter-tipped syringe | Medicine Cup | 15 | 15 |
| 40 mg to 80 mg | 5 Fr PUR NG tube or Any ≥6 Fr NG tube | 3 | 2 |
* Fr = French; PUR = polyurethane
† With ENFit syringe, a medicine straw (large bore) is needed to aid withdrawal of the mixture from the medicine cup.
Table 12. Recommendations for administration of PREVYMIS granules in sachet via G tube:
| Dose | G tube* | Liquid type | Syringe type† | Mixing container | Initial volume (mL) | Rinse volume (mL) |
|---|---|---|---|---|---|---|
| 120 mg to 480 mg | Any G tube | Milk, apple juice, or formula Do not use water | Appropriately sized ENFit or catheter- tipped syringe | Medicine Cup | 15 | 15 |
| 40 mg to 80 mg | Any 12 Fr G tube | 3 | 2 |
* Fr = French
† With ENFit syringe, a medicine straw (large bore) is needed to aid withdrawal of the mixture from the medicine cup.
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