Livtencity

About Maribavir

• Maribavir, marketed as Livtencity, is an antiviral drug employed in the treatment of post-transplant cytomegalovirus (CMV). 
• Acting as a cytomegalovirus pUL97 kinase inhibitor, Maribavir hinders the activity of the human cytomegalovirus enzyme pUL97, thereby impeding virus replication. 
• It received approval for medical use in the United States in November 2021 and in the European Union in November 2022. Recognized by the US Food and Drug Administration (FDA) as a pioneering medication, Maribavir is considered first-in-class. 
• Due to the activation of ganciclovir and valganciclovir by the cytomegalovirus pUL97 kinase, coadministration with these drugs is discouraged, as Maribavir may diminish their antiviral effectiveness.
• Cytomegalovirus belongs to the virus genus within the order Herpesvirales, part of the Herpesviridae family in the Betaherpesvirinae subfamily. Humans and other primates act as natural hosts for these viruses. Within this genus, there are 11 species, with human betaherpesvirus 5 being the specific species that infects humans.

Strength: 

Each tablet contains 200 mg of Maribavir.

Recommended Dosage:

• The recommended dose for adults and pediatric patients (12 years of age and older, weighing at least 35 kg) is 400 mg (two 200 mg tablets) taken orally twice daily, with or without food. 
• If co-administered with carbamazepine, the Livtencity dosage should be increased to 800 mg twice daily. 
• When co-administered with phenytoin or phenobarbital, the Livtencity dosage should be increased to 1,200 mg twice daily.

Important:

Inform your healthcare provider about all the medications you are using, including prescription and over-the-counter drugs, as well as vitamins and herbal supplements. Livtencity 200 mg may impact the effectiveness of other medications, and conversely, other drugs may affect how Livtencity works, potentially leading to severe side effects. Specifically, inform your healthcare provider if you are taking anticonvulsant medications for seizures. 

You can request a list of medications that may interact with Livtencity from your healthcare provider or pharmacist. Refrain from starting any new medication without consulting your healthcare provider, who will advise on the safety of taking Livtencity alongside other drugs. Maintain a record of the medications you are on, and share this list with your healthcare provider and pharmacist whenever you receive a new prescription.

Warnings & Precautions

• Livtencity tablets may counteract the antiviral efficacy of ganciclovir and valganciclovir, making coadministration not recommended. 
• Avoid coadministration with strong CYP3A4 inducers. Virologic failure may occur during or after Livtencity treatment; monitor CMV DNA levels and assess for resistance if there’s an inadequate response. 
• Some maribavir pUL97 resistance-related substitutions may confer cross-resistance to ganciclovir and valganciclovir. 
• Concurrent use of Livtencity with certain drugs can lead to significant interactions, potentially diminishing therapeutic effects or causing adverse reactions. 
• Livtencity has the potential to elevate drug concentrations of immunosuppressant drugs, such as tacrolimus, cyclosporine, sirolimus, and everolimus, where minimal concentration changes may result in serious adverse events. 
• Regularly monitor immunosuppressant drug levels during Livtencity treatment, especially upon initiation and discontinuation, and adjust doses accordingly.

Common Livtencity Side Effects:

• Changes in taste (Dysgeusia) 
• Nausea 
• Diarrhea 
• Vomiting 
• Fatigue 
• Loss of appetite 
• Headache 
• Abdominal pain 
• Fever
• Chills
• Insomnia
• Anxiety
• Depression

Use in Specific Population

• Limited data is accessible regarding the utilization of Livtencity 200 mg in pregnant individuals, and an insufficient understanding of the potential risks for major birth defects, miscarriage, or other adverse outcomes for both the maternal and fetal health exists. 
• The presence of Livtencity in human breast milk, its impact on nursing infants, and its influence on milk production remain undisclosed. 
• The safety and efficacy of Livtencity have not been established in patients under the age of 12. 
• Dosage adjustment is unnecessary for patients aged 65 and above, as indicated by population pharmacokinetics analysis. 
• No Livtencity dosage adjustments are needed for individuals with mild, moderate, or severe renal impairment according to Clinical Pharmacology. However, the use of Livtencity in patients with end-stage renal disease (ESRD), including those on dialysis, has not been studied. 
• Similarly, for patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment, no Livtencity dose adjustment is required, as detailed in Clinical Pharmacology. The administration of Livtencity in patients with severe hepatic impairment remains unexplored.

Storage and Handling

Store within the temperature range of 20°C to 25°C (68°F to 77°F), with brief exposure permitted at 15°C to 30°C (59°F to 86°F). Store the medication in its original carton to shield it from light until the time of use. Avoid freezing, shaking, and exposure to heat.

• Bottles of 28 tablets with child-resistant caps
• Bottles of 56 tablets with child-resistant caps