LIVTENCITY Film-coated tablet Ref.[50474] Active ingredients: Maribavir

LIVTENCITY should be initiated by a physician experienced in the management of patients who have undergone solid organ transplant or haematopoietic stem cell transplant.

Posology

The recommended dose of LIVTENCITY is 400 mg (two 200 mg tablets) twice daily resulting in a daily dose of 800 mg for 8 weeks. Treatment duration may need to be individualised based on the clinical characteristics of each patient.

Co-administration with CYP3A inducers

Co-administration of LIVTENCITY with the strong cytochrome P450 3A (CYP3A) inducers rifampicin, rifabutin or St. John’s wort is not recommended due to potential for a decrease in efficacy of maribavir.

If co-administration of LIVTENCITY with other strong or moderate CYP3A inducers (e,g., carbamazepine, efavirenz, phenobarbital and phenytoin) cannot be avoided, the LIVTENCITY dose should be increased to 1 200 mg twice daily (see sections 4.4, 4.5 and 5.2).

Missed dose

Patients should be instructed that if they miss a dose of LIVTENCITY, and the next dose is due within the next 3 hours, they should skip the missed dose and continue with the regular schedule. Patients should not double their next dose or take more than the prescribed dose.

Special populations

Elderly patients

No dose adjustment is required for patients over 65 years (see sections 5.1 and 5.2).

Renal impairment

No dose adjustment of LIVTENCITY is required for patients with mild, moderate or severe renal impairment. Administration of LIVTENCITY in patients with end stage renal disease (ESRD), including patients on dialysis, has not been studied. No dose adjustments is expected to be required for patients on dialysis due to the high plasma protein binding of maribavir (see section 5.2).

Hepatic impairment

No dose adjustment of LIVTENCITY is required for patients with mild (Child-Pugh Class A) or moderate hepatic impairment (Child-Pugh Class B). Administration of LIVTENCITY in patients with severe hepatic impairment (Child-Pugh Class C) has not been studied. It is not known whether exposure to maribavir will significantly increase in patients with severe hepatic impairment. Therefore, caution is advised when LIVTENCITY is administered to patients with severe hepatic impairment (see section 5.2).

Paediatric population

The safety and efficacy of LIVTENCITY in patients below 18 years of age have not been established. No data are available.

Method of administration

Oral use.

LIVTENCITY is intended for oral use only and can be taken with or without food. The film-coated tablet can be taken as a whole tablet, a crushed tablet, or a crushed tablet through a nasogastric or orogastric tube.

In Study 303, an accidental overdose of a single extra dose occurred in 1 LIVTENCITY-treated subject on Day 13 (1 200 mg total daily dose). No adverse reactions were reported.

In Study 202, 40 subjects were exposed to doses of 800 mg twice daily and 40 subjects were exposed to 1 200 mg twice daily for a mean of approximately 90 days. In Study 203, 40 subjects were exposed to doses of 800 mg twice daily and 39 subjects were exposed to 1 200 mg twice daily for a maximum of 177 days. There were no appreciable differences in the safety profile in either study compared to the 400 mg twice daily group in Study 303 in which subjects received maribavir for a maximum of 60 days.

There is no known specific antidote for maribavir. In case of overdose, it is recommended that the patient be monitored for adverse reactions and appropriate symptomatic treatment instituted. Due to the high plasma protein binding of maribavir, dialysis is unlikely to reduce plasma concentrations of maribavir significantly.

30 months.

Do not store above 30°C.

High-density polyethylene (HDPE) bottles with child resistant cap.

Pack-sizes of 28 or 56 film-coated tablets.

Not all pack sizes may be marketed.

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