LIVTENCITY▼® (maribavir) dosing summary

LIVTENCITY (maribavir) is indicated for the treatment of cytomegalovirus (CMV) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet in adult patients who have undergone a haematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT).¹
Consideration should be given to official guidance on the appropriate use of antiviral agents.¹

This is only a summary for the dosing of LIVTENCITY, please consult the Summary of Product Characteristics for LIVTENCITY before prescribing.

In the pivotal Phase 3 trial, LIVTENCITY delivered double the viraemia clearance (55.7%) compared to investigator-assigned therapy (IAT) (23.9%) – primary endpoint²

Confirmed viraemia clearance^* of refractory/resistant CMV in all transplants (HSCT and SOT) at Study Week 8²

*Plasma CMV DNA <137 IU/mL in 2 consecutive tests ≥5 days apart.²

Prescribing LIVTENCITY (maribavir) summary

Twice-daily oral administration

• The recommended dose of LIVTENCITY is 400 mg (two 200 mg tablets) twice daily resulting in a daily dose of 800 mg for 8 weeks¹
• LIVTENCITY is an oral treatment that can be taken at home by a patient¹
• LIVTENCITY can be taken with or without food. The tablet can be taken as a whole tablet, a crushed tablet, or a crushed tablet through a nasogastric or orogastric tube¹
• Patients should be instructed that if they miss a dose of LIVTENCITY, and the next dose is due within the next 3 hours, they should skip the missed dose and continue with the regular schedule. Patients should not double their next dose or take more than the prescribed dose¹

LIVTENCITY should be initiated by a physician experienced in the management of patients who have undergone SOT or HSCT.¹

Use in special patient populations

• LIVTENCITY does not require dose adjustments to address renal or mild-to-moderate hepatic impairment^*1
• No dose adjustment required for patients over 65 years¹
• Dose adjustment to 1200 mg BID is recommended when co-administered with the anticonvulsants carbamazepine, phenobarbital and phenytoin¹
• Administration of LIVTENCITY in patients with end-stage renal disease, including patients on dialysis, has not been studied*
• Administration of LIVTENCITY in patients with severe hepatic impairment has not been studied therefore caution is advised*

*Administration of LIVTENCITY in patients with end-stage renal disease, including patients on dialysis, has not been studied. No dose adjustment is expected to be required for patients on dialysis due to the high plasma protein binding of maribavir. Administration of LIVTENCITY in patients with severe hepatic impairment has not been studied. It is not known whether exposure to maribavir will significantly increase in patients with severe hepatic impairment. Therefore, caution is advised when LIVTENCITY is administered to patients with severe hepatic impairment.¹

Please see the SmPC for details on interactions and full details about dosing before prescribing

Treatment duration may need to be individualised based on the clinical characteristics of each patient.¹

IAT = one or a combination of ganciclovir, valganciclovir, foscarnet, or cidofovir².
BID = twice daily; IAT = investigator-assigned therapy; HSCT = haematopoietic stem cell transplant; SOT = solid organ transplant.

References:

1. LIVTENCITY UK Summaries of Product Characteristics [GB & NI].
2. Avery RK, et al. Clin Infect Dis. 2022;75(4):690–701.