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Anti-CMV (UL97 inhibitor) Pregnancy: US label §8.1: no adequate human data are available to establish whether maribavir poses a risk to pregnancy outcomes. In animal reproduction studies embryo-fetal survival was decreased in rats (but not rabbits) at exposures less than those seen in humans at the recommended human dose, with a decrease in viable fetuses and an increase in early resorptions and post-implantation losses at doses from 100 mg/kg/day. The background risk of major birth defects and miscarriage for the indicated population is unknown.

Maribavir

Brand names: Livtencity

Maribavir is an antiviral agent used to treat cytomegalovirus (CMV) infection and disease that is refractory, with or without resistance, to prior anti-CMV therapy, particularly after transplantation.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 400 mg (two 200 mg tablets) twice daily
Route: Oral - taken with or without food; tablets may be given whole, dispersed or crushed, or as dispersed tablets through a nasogastric or orogastric tube (French size 10 or larger)
Frequency: Twice daily
US label §2.1 (LIVTENCITY 200 mg tablets, Takeda; no UK SPC was captured in this bundle - clinician to verify against the UK SPC). The recommended dosage in adults and paediatric 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. DOSE INCREASES WITH INTERACTING DRUGS: if co-administered with carbamazepine, increase to 800 mg (four 200 mg tablets) twice daily (§2.2); if co-administered with phenytoin or phenobarbital, increase to 1,200 mg (six 200 mg tablets) twice daily (§2.2); if co-administered with rifabutin, increase to 800 mg (four 200 mg tablets) twice daily (§2.3). ADMINISTRATION (§2.4): for dispersed or crushed tablets by mouth, add 30 mL of drinking water per 400 mg (60 mL for 800 mg, 90 mL for 1,200 mg), swirl gently and give before the particles settle, then rinse the container twice with 15 mL water and give the rinse; the suspension may be prepared ahead and stored at room temperature for up to 8 hours. Only two tablets can be dispersed and given via an NG or OG tube at a time. PAEDIATRIC (§8.4): the recommended dosing regimen in patients 12 years of age and older weighing at least 35 kg is the SAME as in adults - it is not expressed per kg, so no structured paediatric dose is recorded here. Safety and effectiveness have not been established in children younger than 12 years of age. Verify any under-18 use against a children's formulary. ELDERLY (§8.5): no dosage adjustment is required in patients over 65 years. The label does not state a treatment duration in the captured text (the Phase 3 trial treated for up to 8 weeks).

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • US label §4 states: None

Side effects

  • Taste disturbance (dysgeusia) - most common, all grades >10% (§6.1)
  • Nausea (>10%)
  • Diarrhoea (>10%)
  • Vomiting (>10%)
  • Fatigue (>10%)

Interactions

  • Ganciclovir and valganciclovir - maribavir may antagonise their antiviral activity by inhibiting CMV pUL97 kinase, which is required for their activation; co-administration is NOT recommended (§5.1, §7.1)
  • Strong CYP3A4 inducers - co-administration is not recommended, except with a dose adjustment for selected anticonvulsants: carbamazepine (increase to 800 mg twice daily) and phenytoin (increase to 1,200 mg twice daily) (§7.2, §2.2)
  • Moderate CYP3A4 inducers - rifabutin (increase to 800 mg twice daily) and phenobarbital (increase to 1,200 mg twice daily) require a dose adjustment (§7.2, §2.2, §2.3)
  • Immunosuppressants with narrow therapeutic margins - maribavir has the potential to increase concentrations of tacrolimus, ciclosporin, sirolimus and everolimus, where minimal concentration changes may lead to serious adverse events; monitor levels frequently throughout treatment, especially after starting and after stopping maribavir, and adjust the dose as needed (§5.3)

Clinical monograph

How it works

It inhibits the CMV UL97 protein kinase, interfering with viral DNA replication, encapsidation and nuclear egress of viral particles.

Prescribing in practice

  • Because it inhibits UL97, it antagonises ganciclovir and valganciclovir, which depend on UL97 for activation, so co-administration with these agents should be avoided.
  • Resistance can emerge during treatment, so persistent or rising CMV viral load should prompt reassessment.
  • It interacts with several drugs as a CYP3A substrate and a P-glycoprotein inhibitor, so co-medication should be reviewed against current prescribing references.

Monitoring

Monitor CMV viral load to assess response and detect possible resistance during treatment.

Counselling the patient

  • This medicine treats a CMV infection that did not respond to earlier treatment.
  • Taste disturbance is a common side effect and usually settles.
  • Attend blood tests to check that the virus is responding.

Evidence & guidelines

A randomised controlled trial demonstrated superiority over investigator-assigned anti-CMV therapy for clearance of refractory or resistant CMV infection.

Reference: NICE TA860; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.