Cytomegalovirus pUL97 Kinase InhibitorPrescription OnlyPregnancy Cat. Not classifiedFDA Yes
Livtencity
MARIBAVIR
1 INDICATIONS AND USAGE 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 treatm...
Medically reviewed by MedCentralHub Medical Review Board, Licensed Pharmacists & Physicians ·
Brand names:Livtencity
Quick Reference
Medicine ClassCytomegalovirus pUL97 Kinase Inhibitor
FDA ApprovedYes
PregnancyCategory Not classified
Quick Facts
- Active ingredient
- MARIBAVIR
- Medicine class
- Cytomegalovirus pUL97 Kinase Inhibitor
- Brand names
- Livtencity
- Availability
- Prescription only (Rx)
- Pregnancy category
- Not classified
- Half-life
- Half-life (t 1/2 ) in transplant patients (h), mean 4
- FDA approved
- Yes
What Is Livtencity?
1 INDICATIONS AND USAGE 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 treatm...
Livtencity (MARIBAVIR) belongs to the Cytomegalovirus pUL97 Kinase Inhibitor class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Livtencity. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Livtencity with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Livtencity is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
1 INDICATIONS AND USAGE 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.
( 1 , 8.4 )
Dosage Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult Dosage
2 DOSAGE AND ADMINISTRATION 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, in
Available Forms
Available Strengths
Side Effects
Common
- 6 ADVERSE REACTIONS 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
Serious
- 5 WARNINGS AND PRECAUTIONS 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.
Rare
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
Warnings & Contraindications
5 WARNINGS AND PRECAUTIONS 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-resist
How Livtencity Works
12.1 Mechanism of Action LIVTENCITY is an antiviral drug against human CMV [see Microbiology (12.4) ] .
Pharmacokinetics
Absorption
Absorption When taken orally with a high fat, high caloric meal vs fasted, the AUC 0‑∞ and C max (geometric mean ratio [90% CI] of maribavir are 0
Half-Life
Half-life (t 1/2 ) in transplant patients (h), mean 4
Metabolism
metabolism Half-life (t 1/2 ) in transplant patients (h), mean 4
Excretion
Excretion % of dose excreted as total 14 C (unchanged drug) in urine Dosing in mass balance study: single-dose administration of [ 14 C] maribavir oral solution 400 mg containing 200 nCi of total radi
Pregnancy & Breastfeeding Safety
Not classified
Breastfeeding
Many medications pass into breast milk in varying amounts. Before using Livtencitywhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
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) permitted [see USP Controlled Room Temperature] .
Frequently Asked Questions
Related on MedCentralHub
- Class hub
Cytomegalovirus pUL97 Kinase Inhibitor alternatives
Compare all Cytomegalovirus pUL97 Kinase Inhibitor medications — uses, side effects, and cost differences
- Detail
Livtencity dosage guide
Adult, pediatric, renal, and hepatic dosing for Livtencity
- Detail
Livtencity side effects
Complete adverse effect profile including common, serious, and rare reactions
Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Livtencity
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
Last reviewed by MedCentralHub Medical Review Board · MedCentralHub Editorial Policy
Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.