Maribavir

LIVTENCITY is an antiviral drug against human CMV [see Microbiology (12.4) ] .

• 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 [see Use in Specific Populations (8.4) and Clinical Studies (14) ] . LIVTENCITY is a cytomegalovirus (CMV) pUL97 kinase inhibitor indicated for the treatment of adults and pediatric patients (12 years of age and older and weighing at least 35 kg) with post-transplant CMV infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet.

• None. None.contraindicated

400 mg (two 200 mg tablets) orally twice daily with or without food. ( 2.1 , 8.4 ) 2.1 Recommended Dosage The recommended dosage in adults and pediatric patients (12 years of age and older and weighing at least 35 kg) is 400 mg (two 200 mg tablets) taken orally twice daily with or without food [see Use in Specific Populations (8.4) , Clinical Pharmacology (12.3) and Clinical Studies (14) ] . 2.2 Dosage Adjustment When Coadministered with Anticonvulsants If LIVTENCITY is coadministered with carbamazepine, increase the dosage of LIVTENCITY to 800 mg (four 200 mg tablets) twice daily [see Drug Interactions (7.3) and Clinical Pharmacology (12.3) ] . If LIVTENCITY is coadministered with phenytoin or phenobarbital, increase the dosage of LIVTENCITY to 1,200 mg (six 200 mg tablets) twice daily [see Drug Interactions (7.3) and Clinical Pharmacology (12.3) ] . 2.3 Dosage Adjustment When Coadministered with Rifabutin If LIVTENCITY is co-administered with rifabutin, increase the dosage of LIVTENCITY to 800 mg (four 200 mg tablets) twice daily [see Drug Interactions (7.3) and Clinical Pharmacology (12.3) ] . 2.4 Administration Instructions The immediate-release tablets can be taken as whole, dispersed or crushed tablets by mouth, or as dispersed tablets through a nasogastric or orogastric tube (French size 10 or larger). The suspension may be prepared ahead of time and stored at room temperature for up to 8 hours. Administration of Dispersed Tablets or Crushed Tablets by Mouth Place the appropriate number of tablets for the prescribed dose into a suitable container.

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 potentially significant drug interactions, some of which may lead to reduced therapeutic effect of LIVTENCITY or adverse reactions of concomitant drugs. ( 5.1 , 5.3 , 7.1 , 7.2 , 7.3 ) LIVTENCITY has the potential to increase the drug concentrations of certain immunosuppressant drugs 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 the dose, as needed. ( 5.3 ) 5.1 Risk of Reduced Antiviral Activity When Coadministered 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 [see Drug Interactions (7.1) and Microbiology (12.4) ] .

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 2.

8.1 Pregnancy Risk Summary No adequate human data are available to establish whether LIVTENCITY poses a risk to pregnancy outcomes. In animal reproduction studies, embryo-fetal survival was decreased in rats, but not in rabbits, at maribavir exposures less than those observed in humans at the recommended human dose (RHD) (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In a combined fertility and embryofetal development study, maribavir was administered to male and female rats at oral doses of 100, 200, or 400 mg/kg/day. Females were dosed for 15 consecutive days prior to pairing, throughout pairing, and up to gestation day (GD) 17, while males were dosed 29 days prior to mating and throughout mating. A decrease in the number of viable fetuses and increase in early resorptions and post-implantation losses were observed at ≥100 mg/kg/day (at exposures approximately half the human exposure at the RHD). Intermittent reduced body weight gain was observed in pregnant animals at ≥200 mg/kg/day.

Metabolism

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).

There is no known specific antidote for LIVTENCITY. In case of overdose, it is recommended that the patient be monitored for adverse reactions and appropriate symptomatic treatment instituted. Due to the high plasma protein binding of LIVTENCITY, dialysis is unlikely to reduce plasma concentrations of LIVTENCITY significantly.

• Nov 23, 2021NDANDA215596Takeda Pharms Usa

1. 1Death31413%
2. 2Dysgeusia25811%
3. 3Taste Disorder2279.7%
4. 4Hospitalisation2239.6%
5. 5Cytomegalovirus Infection1807.7%
6. 6Drug Resistance1767.6%
7. 7Fatigue1727.4%
8. 8Off Label Use1697.3%
9. 9Drug Ineffective1576.7%
10. 10Cytomegalovirus Infection Reactivation1365.8%
11. 11Product Use Issue1335.7%
12. 12Viral Load Increased1265.4%
13. 13Diarrhoea1255.4%
14. 14Nausea1134.8%
15. 15Cytomegalovirus Viraemia783.3%

The 10 most recently updated of 25 ClinicalTrials.gov registrations naming Maribavir as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study of Maribavir in Adults and Children With Post-transplant Cytomegalovirus (CMV) Infection in Argentina
  Recruiting · Observational · 10 enrolled · Takeda
  NCT06213974updated 2026-06-04
• A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Antiviral Activity of Maribavir for the Treatment of Cytomegalovirus (CMV) Infection in Children and Adolescents Who Have Received a Hematopoietic Stem Cell Transplant (HSCT) or a Solid Organ Transplant (SOT)
  Recruiting · Phase 3 · Interventional · 80 enrolled · Takeda
  NCT05319353updated 2026-05-22
• Maribavir vs. Valganciclovir for CMV Prophylaxis in High-Risk Kidney Transplant Recipients
  Completed · Phase 4 · Interventional · 70 enrolled · Medical University of South Carolina
  NCT06034925updated 2026-04-30
• Comparing the Efficacy of Different Durations of Maribavir Treatment Regimens in Allo-HSCT
  Recruiting · Phase 3 · Interventional · 218 enrolled · Ruijin Hospital
  NCT07511127updated 2026-04-06
• A Study of Maribavir in Chinese Adults With Cytomegalovirus (CMV) Infections
  Recruiting · Phase 3 · Interventional · 20 enrolled · Takeda
  NCT06439342updated 2026-03-02
• A Study of Maribavir in Adults With Kidney Failure Who Have a Cytomegalovirus (CMV) Infection After Transplantation
  Recruiting · Observational · 10 enrolled · Takeda
  NCT06243731updated 2025-12-16
• Phase II Trial of Maribavir for CMV in Patients With Lymphoid Malignancy on Bispecific Antibodies
  Recruiting · Phase 2 · Interventional · 20 enrolled · Seoul National University Hospital
  NCT07014319updated 2025-12-04
• A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea
  Recruiting · Observational · 168 enrolled · Takeda
  NCT06555432updated 2025-11-18
• A Survey of Maribavir Tablets in Participants With Cytomegalovirus Infection
  Recruiting · Observational · 250 enrolled · Takeda
  NCT06577363updated 2025-10-07
• A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of Maribavir Administered in Healthy Japanese Participants Compared With Matched, Healthy, Non-Hispanic, Caucasian Participants and to Assess Dose-Proportionality of 3 Doses of Maribavir in Japanese Participants
  Completed · Phase 1 · Interventional · 24 enrolled · Shire
  NCT04497883updated 2025-09-11

Frequently asked questions

How does Maribavir work?

LIVTENCITY is an antiviral drug against human CMV [see Microbiology (12.4) ] .

What is Maribavir used for?

According to FDA labeling, Maribavir carries indications including: 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 [see Use in Specific Populations (8.4) and Clinical Studies (14) ] . LIVTENCITY is a cytomegalovirus (CMV) pUL97 kinase inhibitor indicated for the treatment of adults and pediatric patients (12 years of age and older and weighing at least 35 kg) with post-transplant CMV infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Maribavir?

Maribavir is classified as Other antivirals, Cytomegalovirus pUL97 Kinase Inhibitor, Breast Cancer Resistance Protein Inhibitors, Cytochrome P450 3A4 Inhibitors, Cytomegalovirus pUL97 Kinase Inhibitors, P-Glycoprotein Inhibitors.

What are the brand names for Maribavir?

Maribavir is marketed under brand names including Livtencity.

What are the contraindications for Maribavir?

Maribavir labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.