Livtencity

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. 3 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. 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. 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.

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. 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.

1). 82) days with a maximum of 60 days. The most commonly reported adverse reactions occurring in at least 10% of subjects in the LIVTENCITY group were: taste disturbance (46%), nausea (21%), diarrhoea (19%), vomiting (14%) and fatigue (12%).

The most commonly reported serious adverse reactions were diarrhoea (2%) and nausea, weight decreased, fatigue, immunosuppressant drug level increased, and vomiting (all occurring at < 1%). Tabulated list of adverse reactions The adverse reactions are listed below by body system organ class and frequency.

Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000) or very rare (< 1/10 000).

Table 2:

Adverse reactions identified with LIVTENCITY System Organ Class Frequency Adverse reactions Nervous system disorders Very common Taste disturbance* 10 Common Headache Gastrointestinal disorders Very Common Diarrhoea, Nausea, Vomiting Common Abdominal pain upper General disorders and administration site conditions Very common Fatigue Common Decreased appetite Investigations Common Immunosuppressant drug level increased*, Weight decreased Description of selected adverse reactions* Taste disturbance Taste disturbance (comprised of the reported preferred terms ageusia, dysgeusia, hypogeusia and taste disorder) occurred in 46% of patients treated with LIVTENCITY.

9%) and, for most patients, resolved while patients remained on therapy (37%) or within a median of 7 days (Kaplan-Meier estimate, 95% CI: 4-8 days) after treatment discontinuation. Increases in plasma levels of immunosuppressants Immunosuppressant drug level increase (comprised of the preferred terms immunosuppressant drug level increased and drug level increased) occurred in 9% of patients treated with LIVTENCITY.

Virologic failure during treatment and relapse post-treatment Virologic failure can occur during and after treatment with LIVTENCITY. Virologic relapse during the post-treatment period usually occurred within 4-8 weeks after treatment discontinuation.

Some maribavir pUL97 resistance-associated substitutions confer cross-resistance to ganciclovir and valganciclovir. CMV DNA levels should be monitored and resistance mutations should be investigated in patients who do not respond to treatment.

Treatment should be discontinued if maribavir resistance mutations are detected. CMV disease with CNS involvement LIVTENCITY was not studied in patients with CMV CNS infection. 3). g. meningo-encephalitis). Use with immunosuppressants LIVTENCITY has the potential to increase the concentrations of immunosuppressants that are cytochrome P450 (CYP)3A/P-gp substrates with narrow therapeutic margins (including tacrolimus, cyclosporine, sirolimus and everolimus).

2). Risk of adverse reactions or reduced therapeutic effect due to medicinal product interactions The concomitant use of LIVTENCITY and certain medicinal products may result in known or potentially significant medicinal product interactions, some of which may lead to:  possible clinically significant adverse reactions from greater exposure of concomitant medicinal products.

 reduced therapeutic effect of LIVTENCITY. 5). Sodium content This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

1. 5). 4