Livtencity (Maribavir)
Dosage & administration
400 mg (two 200 mg tablets) orally twice daily with or without food. (
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
The recommended dosing regimen in pediatric patients 12 years of age and older and weighing at least 35 kg is the same as that in adults. Use of LIVTENCITY in this age group is based on the following:
The safety and effectiveness of LIVTENCITY have not been established in children younger than 12 years of age.
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Livtencity prescribing information
Dosage and Administration, (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
Administration of Dispersed Tablets through a Nasogastric (NG) or Orogastric (OG) Tube
| 11/2025 | ||||||||||||
| Warnings and Precautions, | |||||||||||||
| 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 [see Drug Interactions (7)] .See Table 4for steps to prevent or manage these possible or known significant drug interactions, including dosing recommendations. Consider the potential for drug interactions prior to and during LIVTENCITY therapy; review concomitant medications during LIVTENCITY therapy and monitor for adverse reactions. 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. Thus, coadministration of LIVTENCITY with these drugs is not recommended, except with a dose adjustment when coadministered with selected anticonvulsants (carbamazepine and phenytoin). With moderate CYP3A4 inducers rifabutin (antimycobacterial) and phenobarbital (anticonvulsant), a dose adjustment is recommended [see Dosage and Administration (2.2, 2.3)and Drug Interactions (7.3)] . For other moderate CYP3A4 inducers, the appropriate maribavir dose adjustment has not been determined.Use with Immunosuppressant Drugs 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 immunosuppressant dose, as needed [see Drug Interactions (7.3)and Clinical Pharmacology (12.3)] . | 11/2025 |
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
The recommended dosing regimen in pediatric patients 12 years of age and older and weighing at least 35 kg is the same as that in adults. Use of LIVTENCITY in this age group is based on the following:
- Evidence from controlled studies of LIVTENCITY in adults
- Population pharmacokinetic (PK) modeling and simulation demonstrating that age and body weight had no clinically meaningful effect on plasma exposures of LIVTENCITY
- LIVTENCITY exposure is expected to be similar between adults and children 12 years of age and older and weighing at least 35 kg
- The course of the disease is similar between adults and pediatric patients to allow extrapolation of data in adults to pediatric patients[see Dosage and Administration (2.1), Clinical Pharmacology (12.3)and Clinical Studies (14)]
The safety and effectiveness of LIVTENCITY have not been established in children younger than 12 years of age.
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, or cidofovir, including CMV infections with or without confirmed resistance to 1 or more of the IATs. Subjects with CMV disease involving the central nervous system, including the retina, were excluded from the study.
Subjects were stratified by transplant type (HSCT or SOT) and screening CMV DNA levels and then randomized in a 2:1 allocation ratio to receive either LIVTENCITY 400 mg twice daily or IAT as dosed by the investigator for up to 8 weeks. After completion of the treatment period, subjects entered a 12-week follow-up phase.
The mean age of trial subjects was 53 years and most subjects were male (61%), white (76%) and not Hispanic or Latino (83%), with similar distributions across the two treatment arms. The most common treatment used in the IAT arm was foscarnet which was administered in 47 (41%) subjects followed by ganciclovir or valganciclovir, each administered in 28 (24%) subjects. Cidofovir was administered in 6 subjects, the combination of foscarnet and valganciclovir in 4 subjects and the combination of foscarnet and ganciclovir in 3 subjects. Baseline disease characteristics are summarized in Table 9 below.
| Characteristic | LIVTENCITY 400 mg Twice Daily N=235 n (%) | IAT N=117 n (%) |
|---|---|---|
| CMV=cytomegalovirus, DNA=deoxyribonucleic acid, HSCT=hematopoietic stem cell transplant, IAT=investigator assigned anti-CMV treatment, N=number of patients, SOT=solid organ transplant. | ||
Transplant type | ||
| HSCT | 93 (40) | 48 (41) |
| SOT | 142 (60) | 69 (59) |
| Kidney | 74 (52) | 32 (46) |
| Lung | 40 (28) | 22 (32) |
| Heart | 14 (10) | 9 (13) |
| Other (multiple, liver, pancreas, intestine) | 14 (10) | 6 (9) |
CMV DNA levels | ||
| Low (<9,100 IU/mL) | 153 (65) | 85 (73) |
| Intermediate (≥9,100 to <91,000 IU/mL) | 68 (29) | 25 (21) |
| High (≥91,000 IU/mL) | 14 (6) | 7 (6) |
Confirmed symptomatic CMV infection at baseline | ||
| No | 214 (91) | 109 (93) |
| Yesone of the subjects had both CMV syndrome and disease but was counted for CMV disease only. | 21 (9) | 8 (7) |
| CMV syndrome (SOT only) | 9 (43) | 7 (88) |
| Tissue Invasive disease | 12 (57) | 1 (13) |
The primary efficacy endpoint was confirmed CMV DNA level < LLOQ (i.e., <137 IU/mL) as assessed by COBAS®AmpliPrep/COBAS®TaqMan®CMV test) at the end of Week 8. The key secondary endpoint was CMV DNA level < LLOQ and CMV infection symptom control at the end of Study Week 8 with maintenance of this treatment effect through Study Week 16.
For the primary endpoint, LIVTENCITY was statistically superior to IAT (56% vs 24%, respectively), as shown in Table 10.
| LIVTENCITY 400 mg Twice Daily N=235 n (%) | IAT N=117 n (%) | |
|---|---|---|
| CI=confidence interval; CMV=cytomegalovirus; IAT=investigator-assigned anti-CMV treatment; N=number of patients. | ||
Primary Endpoint: Confirmed CMV DNA Level < LLOQ at Week 8Confirmed CMV DNA level < LLOQ at the end of Week 8 (2 consecutive samples separated by at least 5 days with DNA levels < LLOQ [i.e.:, <137 IU/mL]). | ||
| Responders | 131 (56) | 28 (24) |
| Adjusted difference in proportion of responders (95% CI)Cochran-Mantel-Haenszel weighted average approach was used for the adjusted difference in proportion (maribavir – IAT), the corresponding 95% CI, and the p-value after adjusting for the transplant type and baseline plasma CMV DNA concentration. Only those with both stratification factors were included in the computation. | 33 (23, 43) | |
| p-value: adjusted | <0.001 | |
The reasons for failure to meet the primary endpoint are summarized in Table 11.
| Outcome at Week 8 | LIVTENCITY N=235 n (%) | IAT N=117 n (%) |
|---|---|---|
| CMV=Cytomegalovirus, IAT=Investigator-assigned anti-CMV Treatment, MBV=maribavir. | ||
| Percentages are based on the number of subjects in the Randomized Set. | ||
Responders (Confirmed DNA Level < LLOQ)Confirmed CMV DNA level < LLOQ at the end of Week 8 (2 consecutive samples separated by at least 5 days with DNA levels < LLOQ [i.e.:, <137 IU/mL]). | 131 (56) | 28 (24) |
Non-responders: | 104 (44) | 89 (76) |
Due to virologic failureCMV DNA breakthrough=achieved confirmed CMV DNA level < LLOQ and subsequently became detectable.: | 80 (34) | 42 (36) |
| • CMV DNA never < LLOQ | 48 (20) | 35 (30) |
| • CMV DNA breakthrough | 32 (14) | 7 (6) |
Due to drug/study discontinuation: | 21 (9) | 44 (38) |
| • Adverse events | 8 (3) | 26 (22) |
| • Deaths | 10 (4) | 3 (3) |
| • Withdrawal of consent | 1 (<1) | 9 (8) |
| • Other reasonsOther reasons=other reasons not including adverse events, deaths and lack of efficacy, withdrawal of consent, and non-compliance. | 2 (1) | 6 (5) |
Due to other reasons but remained on studyIncludes subjects who completed study assigned treatment and were non-responders. | 3 (1) | 3 (3) |
The treatment effect of LIVTENCITY was consistent across transplant type, age group, and the presence of CMV syndrome/disease at baseline. However, LIVTENCITY was less effective against subjects with increased CMV DNA levels (≥50,000 IU/mL) and subjects with absence of genotypic resistance
| LIVTENCITY 400 mg Twice Daily N=235 | IAT N=117 | |||
|---|---|---|---|---|
| n/N | % | n/N | % | |
Transplant type | ||||
| SOT | 79/142 | 56 | 18/69 | 26 |
| HSCT | 52/93 | 56 | 10/48 | 21 |
Baseline CMV DNA viral load | ||||
| Low (<9,100 IU/mL) | 95/153 | 62 | 21/85 | 25 |
| Intermediate (≥9,100 to <91,000 IU/mL) | 32/68 | 47 | 5/25 | 20 |
| ≥9,100 to <50,000 IU/mL | 29/59 | 49 | 4/20 | 20 |
| ≥50,000 to <91,000 IU/mL | 3/9 | 33 | 1/5 | 20 |
| High (≥91,000 IU/mL) | 4/14 | 29 | 2/7 | 29 |
Genotypic resistance to other anti-CMV agents | ||||
| Yes | 76/121 | 63 | 15/70 | 21 |
| No | 42/96 | 44 | 10/33 | 30 |
CMV syndrome/disease at baseline | ||||
| Yes | 10/21 | 48 | 1/8 | 13 |
| No | 121/214 | 57 | 27/109 | 25 |
Age Group | ||||
| 18 to 44 years | 28/55 | 51 | 8/32 | 25 |
| 45 to 64 years | 71/126 | 56 | 19/69 | 28 |
| ≥65 years | 32/54 | 59 | 1/16 | 6 |
Table 13 shows results of the secondary endpoint, achievement of CMV DNA level < LLOQ and symptom controlaat Week 8 with maintenance through Week 16.
| LIVTENCITY 400 mg Twice Daily N=235 n (%) | IAT N=117 n (%) | |
|---|---|---|
| Responders | 44 (19) | 12 (10) |
| Adjusted difference in proportion of responders (95% CI)Cochran-Mantel-Haenszel weighted average approach was used for the adjusted difference in proportion (maribavir – IAT), the corresponding 95% CI, and the p-value after adjusting for the transplant type and baseline plasma CMV DNA concentration. Only those with both stratification factors were included in the computation. | 9 (2,17) | |
| p-value: adjusted | 0.013 |
Virologic relapse during follow-up period: After the end of treatment phase, 65/131 (50%) of subjects in the LIVTENCITY group and 11/28 (39%) subjects in the IAT group who achieved CMV DNA level < LLOQ experienced virologic relapse during the follow-up period. Most of the relapses 58/65 (89%) in LIVTENCITY group and 11/11 (100% in IAT group)] occurred within 4 weeks after study drug discontinuation; and the median time to relapse after CMV DNA level < LLOQ was 15 days (range 7, 71) in the LIVTENCITY group and 15 days (range 7, 29) in the IAT group
New onset symptomatic CMV infection: For the entire study period, a similar percentage of subjects in each treatment group developed new onset symptomatic CMV infection (LIVTENCITY 6% [14/235]; IAT 6% [7/113]).
Overall mortality: All-cause mortality was assessed for the entire study period. A similar percentage of subjects in each treatment group died during the trial (LIVTENCITY 11% [27/235]; IAT 11% [13/117]).
400 mg (two 200 mg tablets) orally twice daily with or without food. (
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
The recommended dosing regimen in pediatric patients 12 years of age and older and weighing at least 35 kg is the same as that in adults. Use of LIVTENCITY in this age group is based on the following:
- Evidence from controlled studies of LIVTENCITY in adults
- Population pharmacokinetic (PK) modeling and simulation demonstrating that age and body weight had no clinically meaningful effect on plasma exposures of LIVTENCITY
- LIVTENCITY exposure is expected to be similar between adults and children 12 years of age and older and weighing at least 35 kg
- The course of the disease is similar between adults and pediatric patients to allow extrapolation of data in adults to pediatric patients[see Dosage and Administration (2.1), Clinical Pharmacology (12.3)and Clinical Studies (14)]
The safety and effectiveness of LIVTENCITY have not been established in children younger than 12 years of age.
Tablet: 200 mg, blue, oval shaped convex tablet debossed with "SHP" on one side and "620" on the other side.
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)
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. Maribavir had no effect on embryo-fetal growth or development at dose levels up to 400 mg/kg/day, at exposures similar to those observed in humans at the RHD.
No significant toxicological effects on embryo-fetal growth or development were observed in rabbits when maribavir was administered at oral doses up to 100 mg/kg/day from GD 8 to 20, at exposures approximately half the human exposure at the RHD.
In the pre-and post-natal developmental toxicity study, maribavir was administered to pregnant rats at oral doses of 50, 150, or 400 mg/kg/day from GD 7 to post-natal day (PND) 21. A delay in developmental milestones was observed, including pinna detachment at doses ≥150 mg/kg/day and eye opening and preputial separation associated with reduced bodyweight gain of the offspring at 400 mg/kg/day. In addition, decreased fetal survival and litter loss was observed due to maternal toxicity and poor maternal care, respectively, at doses ≥150 mg/kg/day. No effects were observed at 50 mg/kg/day (which is estimated to be less than the human exposure at the RHD). No effects on number of offspring, proportion of males, number of live pups, or survival to PND 4 were observed at any dose in the offspring born to the second generation.
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.
None.