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. 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. Based on nonclinical data, CNS penetration of maribavir is expected to be low compared to plasma levels (see Pharmacology: Pharmacokinetics and Toxicology: Preclinical safety data under Actions). Therefore, LIVTENCITY is not expected to be effective in treating CMV CNS infections (e.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). The plasma levels of these immunosuppressants must be frequently monitored throughout treatment with LIVTENCITY, especially following initiation and after discontinuation of LIVTENCITY, and doses should be adjusted, as needed (see Interactions, Adverse Reactions and Pharmacology: Pharmacokinetics under Actions).
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 6 for steps to prevent or manage these known or potentially significant medicinal product interactions, including dosing recommendations (see Contraindications and Interactions).
Sodium content: This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.
Effects on ability to drive and use machines: LIVTENCITY has no influence on the ability to drive and use machines.