Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS 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 cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of LIVTENCITY was evaluated in one Phase 3 multicenter, randomized, open-label, active-control trial in which 352 adult transplant recipients were randomized, and treated with LIVTENCITY (N=234) or Investigator-Assigned Treatment (IAT) consisting of monotherapy or dual therapy with ganciclovir, valganciclovir, foscarnet, or cidofovir as dosed by the investigator (N=116) for up to 8-weeks following a diagnosis of CMV infection/disease refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, foscarnet or cidofovir.
The mean treatment durations (SD) for LIVTENCITY and IAT were 48.6 (± 13.82) and 31.2 (± 16.91) days, respectively.
The most common adverse events occurring in more than 10% of subjects receiving LIVTENCITY are outlined in Table
Table 2: Adverse Events (All Grades) Reported in >10% of Subjects in the LIVTENCITY Group in Trial 303 ADVERSE EVENT LIVTENCITY N=234 (%) IAT IAT (Investigator-Assigned Treatment) included monotherapy or dual therapy with ganciclovir, valganciclovir, foscarnet, or cidofovir as dosed by the investigator.
N=116 (%) Taste disturbance taste disturbance includes the following reported preferred terms: ageusia, dysgeusia, hypogeusia and taste disorder.
46 4 Nausea 21 22 Diarrhea 19 21 Vomiting 14 16 Fatigue 12 9 Similar proportions of subjects experienced serious adverse events (38% in the LIVTENCITY group and 37% in the IAT group).
5 WARNINGS AND PRECAUTIONS 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.
Like all medications, Livtencity can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: