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DrugLivtencity™ (maribavir) [Takeda Pharmaceuticals America, Inc.]

April 2022

Therapeutic area - Antivirals, General

Initial approval criteria

  • Patient is ≥ 12 years of age AND
  • Patient must weigh ≥ 35 kilogram (kg) AND
  • Patient is a recipient of a hematopoietic stem cell or solid organ transplant AND
  • Patient has documented cytomegalovirus (CMV) infection in whole blood or plasma (screening value ≥ 2,730 IU/mL in whole blood or ≥ 910 IU/mL in plasma) in 2 consecutive assessments separated by ≥ 1 day AND
  • Patient has current CMV infection that is refractory (documented failure to achieve > 1 log10 decrease in CMV deoxyribonucleic acid [DNA] level in whole blood or plasma after ≥ 14 days treatment) to anti-CMV treatment agents (ganciclovir, valganciclovir, cidofovir, or foscarnet), even with documented genetic mutations associated with resistance AND
  • Maribavir will NOT be coadministered with ganciclovir or valganciclovir AND
  • Patient will be monitored for clinically important drug interactions that could result in decreased therapeutic effect of maribavir
  • Initial approval is for 6 months

Renewal criteria

  • Patient must continue to meet the initial approval criteria AND
  • Patient must have disease improvement and/or stabilization OR improvement in the slope of decline (> 1 log10 decrease in CMV DNA level in whole blood or plasma after 14 days or longer treatment) AND
  • Patient has NOT experienced any treatment-restricting adverse effects (e.g., dysgeusia, diarrhea, nausea, and recurrence of underlying disease) AND
  • Patient is NOT a non-responder (resistant) to maribavir
  • Renewal approval is for 6 months

Quantity limits

  • 800 mg daily 
  • With carbamazepine: 1,600 mg daily 
  • With phenytoin or phenobarbital: 2,400 mg daily


MHCP Provider Resource Center 651-431-2700 or 800-366-5411

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