LIVTENCITY
Clinical safety rating: caution
Comprehensive clinical and safety monograph for LIVTENCITY (LIVTENCITY).
LIVTENCITY (maribavir) is an inhibitor of the human cytomegalovirus (CMV) UL97 protein kinase, which is essential for viral DNA replication, encapsidation, and egress of mature virions from the infected cell. By blocking UL97 kinase activity, maribavir inhibits viral replication.
| Metabolism | Primarily metabolized via cytochrome P450 (CYP) 3A4/5 and secondarily by CYP1A2. Also metabolized by flavin-containing monooxygenase (FMO) 3. |
| Excretion | Primarily hepatobiliary excretion; unchanged drug and metabolites eliminated in feces (86%) and urine (14%). |
| Half-life | Terminal elimination half-life is approximately 20 hours, supporting once-daily dosing for sustained antiviral activity. |
| Protein binding | Approximately 99.9% bound to plasma proteins, primarily albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | Approximately 0.37 L/kg, indicating distribution primarily in extracellular fluid and plasma. |
| Bioavailability | Approximately 40% after oral administration (range 30–50%) due to first-pass metabolism. |
| Onset of Action | Oral administration: not applicable; steady-state concentrations achieved within 5 days of once-daily dosing. |
| Duration of Action | Sustained for 24 hours with once-daily dosing, maintaining plasma concentrations above EC50 for CMV throughout the dosing interval. |
200 mg orally once daily with food.
| Dosage form | TABLET |
| Renal impairment | No dose adjustment required for GFR ≥30 mL/min. For GFR <30 mL/min or end-stage renal disease (ESRD) on hemodialysis: not recommended. |
| Liver impairment | Child-Pugh Class A: no adjustment. Child-Pugh Class B or C: not recommended. |
| Pediatric use | Not approved for pediatric patients under 18 years. |
| Geriatric use | No specific dose adjustment; use with caution due to potential age-related renal impairment. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for LIVTENCITY (LIVTENCITY).
| Breastfeeding | It is unknown whether maribavir is excreted in human breast milk. In lactating rats, maribavir was detected in milk at concentrations similar to maternal plasma. No data on M/P ratio in humans. Due to the potential for serious adverse reactions in nursing infants, women should not breastfeed during treatment and for at least 1 week after the last dose. |
| Teratogenic Risk | Based on animal studies and mechanism of action, there is potential for fetal harm. In pregnant rats and rabbits, oral administration of maribavir during organogenesis resulted in increased post-implantation loss and reduced fetal body weights at maternally toxic doses. No structural malformations were observed. There are no adequate and well-controlled studies in pregnant women. Maribavir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Avoid use in first trimester if possible. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Concomitant use with CYP3A4 substrates that have narrow therapeutic indices (e.g., pimozide, ergot alkaloids) or strong CYP3A4 inducers (e.g., rifampin, carbamazepine).","Hypersensitivity to maribavir or any component of the formulation."]
| Precautions | ["Embryo-fetal toxicity: Based on animal data, may cause fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for 6 weeks after the last dose.","Post-transplant lymphoproliferative disorder (PTLD): Monitor for signs and symptoms of PTLD.","Graft rejection: Monitor for graft rejection in transplant recipients.","Risk of drug interactions with strong CYP3A4 inducers or inhibitors: Adjust dose or avoid coadministration."] |
| Food/Dietary | Avoid grapefruit and grapefruit juice during treatment. No other specific food interactions. Take with or without food. |
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| Fetal Monitoring | No specific maternal-fetal monitoring requirements. Standard pregnancy monitoring is recommended. As maribavir may cause fetal harm, women of childbearing potential should have a pregnancy test before starting treatment and use effective contraception during therapy and for at least 1 week after the last dose. If pregnancy occurs, consider reporting to the pregnancy registry. |
| Fertility Effects | In animal studies, maribavir did not affect male or female fertility at doses up to approximately 2.6 times the recommended human dose based on AUC. No human data available. Transient decreases in sperm motility and count were observed in rats but not considered clinically significant. |
| Clinical Pearls | LIVTENCITY (maribavir) is a cytomegalovirus (CMV) pUL97 kinase inhibitor for post-transplant CMV infection/disease refractory to ganciclovir/valganciclovir/foscarnet/cidofovir. Monitor for drug interactions via CYP3A4; avoid strong CYP3A4 inducers/inhibitors. Dose adjustment needed with moderate CYP3A4 inhibitors. Monitor for taste disturbance (dysgeusia) and nausea. Check for QTc prolongation risk with concurrent QT-prolonging drugs. |
| Patient Advice | Take LIVTENCITY exactly as prescribed, with or without food. · Do not take with grapefruit or grapefruit juice. · Report any change in taste, nausea, or diarrhea to your doctor. · Inform your doctor about all medications, including over-the-counter drugs and supplements. · Do not stop taking LIVTENCITY without consulting your doctor, even if you feel better. |