Livtencity Special Precautions

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. Monitor CMV DNA levels and check for resistance if patient does not respond to treatment. Some maribavir pUL97 resistance-associated substitutions confer cross-resistance to ganciclovir and valganciclovir.
Patients with CMV central nervous system (CNS) Infection: LIVTENCITY was not studied in patients with CMV CNS infection. Based on non-clinical data, maribavir may cross the blood-brain barrier in humans, but CNS penetration is expected to be low compared to plasma levels (see Pharmacology: Pharmacokinetics under Actions). The efficacy of LIVTENCITY for the treatment of CMV retinitis has not been established. Therefore, LIVTENCITY is not expected to be effective in treating CMV CNS infections (e.g., meningo-encephalitis, retinitis).
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.
See Table 10 for steps to prevent or manage these known or potentially significant medicinal product interactions, including dosing recommendations (see Contraindications and Interactions).
Use with immunosuppressant drugs: LIVTENCITY has the potential to increase the drug concentrations of immunosuppressant drugs that are cytochrome P450 (CYP)3A/P-gp substrates with narrow therapeutic ranges (including tacrolimus, cyclosporin, sirolimus, and everolimus). Frequently monitor immunosuppressant drug levels throughout treatment with LIVTENCITY, especially following initiation and after discontinuation of LIVTENCITY and adjust the dose, as needed (see Interactions, Adverse Reactions and Pharmacology: Pharmacokinetics under Actions).
Sodium content: LIVTENCITY contains less than 1 mmol sodium (23 mg) per tablet, essentially, "sodium-free".
Effects on laboratory tests: No data available.
Effects on ability to drive and use machines: LIVTENCITY has no influence on the ability to drive and use machines. LIVTENCITY may cross the blood brain barrier in humans, but CNS penetration is expected to be low compared to plasma levels.
Use in Children: The safety and efficacy of LIVTENCITY in patients below 12 years of age have not been established.
Use in the Elderly: No dose adjustment is required for patient over 65 years of age.