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 Precautions, Interactions and Pharmacology: Pharmacokinetics under Actions).
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 Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
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 Pharmacology: Pharmacokinetics under Actions).
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 Pharmacology: Pharmacokinetics under Actions).
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.
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