LIVTENCITY Application Scope

Indicated for 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 (with or without genotypic resistance) to ganciclovir, valganciclovir, cidofovir or foscarnet.

LIVTENCITY Characteristics

Ingredients:

Active Ingredient: Maribavir
Inactive Ingredients: FD&C Blue #1, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, titanium dioxide, and talc.

Properties:

Pharmacological Class: Cytomegalovirus (CMV) pUL97 kinase inhibitor.
Mechanism of Action: Inhibits the CMV pUL97 kinase, which is essential for viral DNA replication.

Packaging Specification:

Form: Oral tablets
Strength: 200 mg per tablet

Storage:

Conditions: Store at 20°C to 25°C (68°F to 77°F).
Stability: Shelf life is 30 months from the date of manufacture when stored under recommended conditions.

Expiry Date:

Refer to the expiration date printed on the packaging.

Executive Standard:

Manufactured in compliance with applicable pharmaceutical manufacturing standards.

Approval Number:

Approved by the U.S. FDA on November 23, 2021.

Date of Revision:

Refer to the latest prescribing information for the most recent revision date.

Manufacturer:

- Takeda Pharmaceuticals USA

Guidelines for the Use of LIVTENCITY

Dosage and Administration:
- Recommended Dose: 400 mg (two 200 mg tablets) taken orally twice daily with or without food.
- Administration: Oral tablets
- Missed Dose: If a dose is missed, take it as soon as remembered unless it is less than 12 hours until the next dose. Do not double doses to make up for a missed dose.
Adverse Reactions:
- Common Adverse Reactions: Headache
- Serious Adverse Reactions:
  - Potential for reduced therapeutic effect when coadministered with certain drugs
  - Risk of virologic failure during treatment and relapse post-treatment
  - Risk of reduced antiviral activity when coadministered with ganciclovir and valganciclovir
Contraindications: None identified.
Precautions: Monitor CMV DNA levels and check for resistance if patient does not respond to treatment.

LIVTENCITY Interactions

Coadministration with ganciclovir or valganciclovir is not recommended due to antagonistic effects.
Strong CYP3A4 inducers may reduce maribavir exposure; dose adjustments needed when coadministered with certain anticonvulsants (e.g. carbamazepine, phenytoin, phenobarbital).
Has potential to increase concentrations of immunosuppressant drugs that are CYP3A4 / P-gp substrates (tacrolimus, cyclosporine, sirolimus, everolimus); monitoring required.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.