Maribavir

What is Maribavir?

• Maribavir (Livtencity) is a cytomegalovirus (CMV) pUL97 kinase inhibitor used to treat post-transplant cytomegalovirus (CMV).

Maribavir

Maribavir

What are the uses of this medicine?

• Maribavir (Livtencity) is a medicine used to treat cytomegalovirus (CMV) infection and disease in adults and children 12 years of age and older weighing at least 77 pounds (35 kg) who have received a transplant, when their infection or disease does not respond to treatment with the medicines ganciclovir, valganciclovir, cidofovir or foscarnet.

How does this medicine work?

• Livtencity is an antiviral drug against human CMV.
• The antiviral activity of maribavir is mediated by competitive inhibition of the protein kinase activity of human CMV enzyme pUL97, which results in inhibition of the phosphorylation of proteins.
• Maribavir inhibited human CMV replication in virus yield reduction, DNA hybridization, and plaque reduction assays in human lung fibroblast cell line (MRC-5), human embryonic kidney (HEK), and human foreskin fibroblast (MRHF) cells.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Livtencity is not recommended to be coadministered with valganciclovir/ganciclovir (vGCV/GCV).
• Livtencity may affect the way other medicines work, and other medicines may affect howLivtencity works and cause serious side effects.
• Especially tell your healthcare provider if you take a seizure (anticonvulsant) medicine.
• The concomitant use of Livtencity and certain drugs may result in potentially significant drug interactions, some of which may lead to reduced therapeutic effect ofLivtencity or adverse reactions of concomitant drugs.
• 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; therefore, coadministration of Livtencity with these drugs is not recommended, except for selected anticonvulsants.
• Livtencity has the potential to increase the drug concentrations of immunosuppressant drugs that are CYP3A4 and/or P-glycoprotein (P-gp) substrates where minimal concentration changes may lead to serious adverse events (including tacrolimus, cyclosporine, sirolimus and everolimus).

Is this medicine FDA approved?

• Maribavir was approved for medical use in the United States in November 2021.

How should this medicine be used?

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.

Dosage Adjustment When Co-administered with Anticonvulsants

• If Livtencity is co-administered with carbamazepine, increase the dosage ofLivtencity to 800 mg twice daily.
• If Livtencity is co-administered with phenytoin or phenobarbital, increase the dosage ofLivtencity to 1,200 mg twice daily.

Administration:

• Take Livtencity 2 times a day.
• Take Livtencity with or without food.
• If you take too much Livtencity, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 200 mg of maribavir.

This medicine is available in fallowing brand namesː

• Livtencity

What side effects can this medication cause?

The most common side effects of this medicine include:

• changes in taste
• nausea
• diarrhea
• vomiting
• tiredness

What special precautions should I follow?

• Livtencity may antagonize the antiviral activity of ganciclovir and valganciclovir. Coadministration is not recommended.
• 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.
• 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.
• Livtencity has the potential to increase the drug concentrations of immunosuppressant drugs that are CYP3A4 and/or P-gp substrates 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 dose, as needed.

What to do in case of emergency/overdose?

Management of overdosage:

• There is no known specific antidote for Livtencity.
• In case of overdose, it is recommended that the patient be monitored for adverse reactions and appropriate symptomatic treatment instituted.
• Due to the high plasma protein binding of Livtencity, dialysis is unlikely to reduce plasma concentrations of Livtencity significantly.

Can this medicine be used in pregnancy?

• It is not known if Livtencity will harm your unborn baby.
• No adequate human data are available to establish whether Livtencity poses a risk to pregnancy outcomes.

Can this medicine be used in children?

• The safety and effectiveness of Livtencity have not been established in children younger than 12 years of age.

What are the active and inactive ingredients in this medicine?

• Active ingredient: maribavir
• Inactive ingredients: FD&C Blue #1, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, titanium dioxide, and talc.

Who manufactures and distributes this medicine?

Distributed by: Takeda Pharmaceuticals America, Inc. Lexington, MA

What should I know about storage and disposal of this medication?

• Store Livtencity at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Livtencity and all medicines out of the reach of children.

• Dailymed label info on Maribavir
• FDA Maribavir

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