LIVTENCITY offers convenience of an oral formulation

LIVTENCITY is available as a 200 mg tablet

Recommended dose: 400 mg (two 200 mg tablets) twice daily for both adults and children 12 years of age and older weighing at least 77 pounds (35 kg)

No dose adjustments are required for patients with impaired renal function or those with mild or moderate hepatic function*

Can be taken with or without food

Dose adjustments are needed when LIVTENCITY is co-administered with certain anticonvulsants.

*Impaired hepatic function=mild (Child-Pugh Class A) or moderate (Child-Pugh Class B). Administration in patients with severe hepatic impairment has not been studied. Impaired renal function=mild, moderate, or severe. Administration in patients with end stage renal disease (ESRD), including patients on dialysis, has not been studied.

Dosing considerations1

Potential drug-drug interactions

  • LIVTENCITY has the potential to increase concentrations of certain drugs1
  • Frequently monitor immunosuppressant drug levels throughout treatment with LIVTENCITY, especially following initiation and after discontinuation of LIVTENCITY and adjust the dose, as needed1
  • Concomitant drug class and name*
  • Effect on concentration
  • Clinical comments

  • Cyclosporine
  • Everolimus
  • Sirolimus
  • Tacrolimus
  • Cyclosporine
  • Everolimus
  • Sirolimus
  • Tacrolimus

Frequently monitor these drug levels throughout treatment with LIVTENCITY, especially following initiation and after discontinuation of LIVTENCITY and adjust dose as needed.

  • Digoxin
  • Digoxin

Caution should be exercised when LIVTENCITY and digoxin are co-administered; serum digoxin concentrations should be monitored and the dose of digoxin may need to be reduced when co-administered with LIVTENCITY.

  • Rifabutin
  • Rifampin
  • LIVTENCITY 

Co-administration with LIVTENCITY is not recommended due to potential for a decrease in efficacy of LIVTENCITY.

  • Carbamazepine
  • Phenobarbital
  • Phenytoin
  • LIVTENCITY 

A dose adjustment of LIVTENCITY (to 800 mg twice daily with Carbamazepine; to 1,200 mg twice daily with Phenobarbital and Phenytoin) is recommended when co-administered with these agents.

  • Rosuvastatin
  • Rosuvastatin

The patient should be closely monitored for rosuvastatin-related events, especially the occurrence of myopathy and rhabdomyolysis.

  • St. John’s wort
  • LIVTENCITY

Co-administration of LIVTENCITY and St. John’s wort is not recommended due to potential for a decrease in efficacy of LIVTENCITY.

=decrease=increase.

*This table is not all inclusive.
The interaction between LIVTENCITY and the concomitant drug was evaluated in a clinical study.
Refer to the respective prescribing information.

Storage and handling1

Tablets are available as:

28
tablets

NDC 64764-800-28
Bottles of 28 tablets with child-resistant caps

56
tablets

NDC 64764-800-56
Bottles of 56 tablets with child-resistant caps

Storage and handling

Store at 20°C to 25°C (68°F to 77°F)

Brief exposure to 15°C to 30°C (59°F to 86°F) is permitted

Learn more about the mechanism of action of LIVTENCITY.

1. Livtencity (maribavir) Prescribing Information. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc. 2. Data on file. Takeda Pharmaceuticals U.S.A., Inc. 3. Avery RK, Alain S, Alexander BD, et al. Clin Infect Dis. 2021;ciab988. 4. Avery RK, Alain S, Alexander BD, et al. Clin Infect Dis. Supplement. 2021. doi.org/10.1093/cid/ciab988. 5. Shannon-Lowe CD, Emery VC. Herpesviridae. 2010;1(4):1-13. 6. Steingruber M, Marschall M. Microorganisms. 2020;8(4):515. 7. Biron KK, Harvey RJ, Chamberlain SC, et al. Antimicrob Agents Chemother 2002;46:2365-2372. 8. Wolf DG, Courcelle CT, Prichard MN, Mocarski ES. Proc Natl Acad Sci U S A. 2001;98(4):1895-1900. 9. Krosky PM, Baek MC, Coen DM. J Virol. 2003;77:905-914. 10. Bigley TM, Reitsma JM, Mirza SP, Terhune SS. J Virol. 2013;87(13):7393-7408.

Important Safety Information

Risk of Reduced Antiviral Activity When Co-administered with Ganciclovir and Valganciclovir

LIVTENCITY may antagonize the antiviral activity of ganciclovir and valganciclovir by inhibiting human CMV pUL97 kinase, which is required for activation/phosphorylation of ganciclovir and valganciclovir. Coadministration of LIVTENCITY with ganciclovir or valganciclovir is not recommended.

Virologic Failure During Treatment and Relapse Post-Treatment

Virologic failure due to resistance can occur during and after treatment with LIVTENCITY. Virologic relapse during the posttreatment period usually occurred within 4-8 weeks after treatment discontinuation. Some maribavir pUL97 resistance-associated substitutions confer cross-resistance to ganciclovir and valganciclovir. Monitor CMV DNA levels and check for maribavir resistance if the patient is not responding to treatment or relapses.

Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions

The concomitant use of LIVTENCITY and certain drugs may result in potentially significant drug interactions, some of which may lead to reduced therapeutic effect of LIVTENCITY or adverse reactions of concomitant drugs.  Consider the potential for drug interactions prior to and during LIVTENCITY therapy; review concomitant medications during LIVTENCITY therapy and monitor for adverse reactions. Refer to the full prescribing information of LIVTENCITY for important drug interactions.

Maribavir is primarily metabolized by CYP3A4. Drugs that are strong inducers of CYP3A4 are expected to decrease maribavir plasma concentrations and may result in reduced virologic response; therefore, coadministration of LIVTENCITY with these drugs is not recommended, except for selected anticonvulsants.  

Use with Immunosuppressant Drugs

LIVTENCITY has the potential to increase the drug concentrations of immunosuppressant drugs that are CYP3A and/or P-gp substrates where minimal concentration changes may lead to serious adverse events (including tacrolimus, cyclosporine, sirolimus and everolimus). Frequently monitor immunosuppressant drug levels throughout treatment with LIVTENCITY, especially following initiation and after discontinuation of LIVTENCITY and adjust immunosuppressant dose, as needed.

Adverse Reactions

The most common adverse events (all grades,> 10%) in subjects treated with LIVTENCITY were taste disturbance, nausea, diarrhea, vomiting, and fatigue.

INDICATION

LIVTENCITY is indicated for the treatment of adults and pediatric patients (12 years of age and older and weighing at least 35 kg) with post-transplant cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with  ganciclovir, valganciclovir, cidofovir or foscarnet.

Please click for Full Prescribing Information.