Cytomegalovirus (CMV) infection and/or disease

Active Ingredient: Maribavir

Indication for Maribavir

Population group: only adults (18 years old or older)
Therapeutic intent: Curative procedure

Maribavir is indicated for the treatment of cytomegalovirus (CMV) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet in adult patients who have undergone a haematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT).

For this indication, competent medicine agencies globally authorize below treatments:

400 mg twice daily for 8 weeks

For:

Dosage regimens

Regimen A: Oral, 400 milligrams maribavir, 2 times daily, over the duration of 8 weeks.

Regimen B: In case that there is substance induction of cytochrome p450 enzyme, oral, 1,200 milligrams maribavir, 2 times daily, over the duration of 8 weeks.

Detailed description

The recommended dose of maribavir is 400 mg (two 200 mg tablets) twice daily resulting in a daily dose of 800 mg for 8 weeks. Treatment duration may need to be individualised based on the clinical characteristics of each patient.

Co-administration with CYP3A inducers

Co-administration of maribavir with the strong cytochrome P450 3A (CYP3A) inducers rifampicin, rifabutin or St. John’s wort is not recommended due to potential for a decrease in efficacy of maribavir.

If co-administration of maribavir with other strong or moderate CYP3A inducers (e,g., carbamazepine, efavirenz, phenobarbital and phenytoin) cannot be avoided, the maribavir dose should be increased to 1 200 mg twice daily.

Missed dose

Patients should be instructed that if they miss a dose of maribavir, and the next dose is due within the next 3 hours, they should skip the missed dose and continue with the regular schedule. Patients should not double their next dose or take more than the prescribed dose.

Dosage considerations

It can be taken with or without food.

Active ingredient

Maribavir

Maribavir is a competitive inhibitor of the UL97 protein kinase. UL97 inhibition occurs at the viral DNA replication phase, inhibiting UL97 serine/threonine kinase by competitively inhibiting the binding of ATP to the kinase ATP-binding site, without affecting the concatemer maturation process, abolishing phosphotransferase inhibiting CMV DNA replication and maturation, CMV DNA encapsidation, and CMV DNA nuclear egress.

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