LIVTENCITY

LIVTENCITY pharmacological activity is due to the parent drug. Following oral administration, plasma maribavir exposure (C max and AUC) increased approximately dose-proportionally following a single dose of 50 to 1600 mg (0.125 to four times the recommended dose) and multiple doses up to 2400 mg per day (three times the recommended daily dose). Maribavir PK is time-independent. With twice-daily dosing, steady state is reached within 2 days, with mean accumulation ratios of C max and AUC ranging ...

14.1 Treatment of Adults with Post-Transplant CMV Infection/Disease That Is Refractory (with or without Genotypic Resistance) to Ganciclovir, Valganciclovir, Cidofovir, or Foscarnet LIVTENCITY was evaluated in a Phase 3, multicenter, randomized, open-label, active-controlled superiority trial (NCT02931539, Trial 303) to assess the efficacy and safety of LIVTENCITY compared to Investigator-Assigned Treatment (IAT) (ganciclovir, valganciclovir, foscarnet, or cidofovir) in 352 HSCT or SOT recipients with CMV infections that were refractory to treatment with ganciclovir, valganciclovir, foscarnet,...

The most common adverse events (all grades, >10%) in subjects treated with LIVTENCITY were taste disturbance, nausea, diarrhea, vomiting, and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America, Inc. at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug canno...

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LIVTENCITY may antagonize the antiviral activity of ganciclovir and valganciclovir. Coadministration is not recommended. ( 5.1 , 7.1 ) Virologic failure can occur during and after treatment with LIVTENCITY. 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. ( 5.2 , 12.4 , 14.1 ) The concomitant use of LIVTENCITY and certain drugs may result in...

7 DRUG INTERACTIONS Refer to the full prescribing information for important drug interactions with LIVTENCITY. ( 5.1 , 5.3 , 7 ) Coadministration with strong CYP3A4 inducers is not recommended, except with a dose adjustment when coadministered with selected anticonvulsants (carbamazepine and phenytoin). When coadministered with the moderate CYP3A4 inducers rifabutin (antimycobacterial) or phenobar...