Livtencity Maribavir Tablets

1. Indications and Usage
Treatment-Resistant CMV Infection/Disease:
Maribavir is indicated for the treatment of refractory (with or without genotypic resistance) cytomegalovirus (CMV) infection and disease in adult and pediatric patients (12 years of age and older and weighing at least 35 kg) following allogeneic hematopoietic stem cell transplantation (HSCT) or solid organ transplantation (SOT).
Note: It is specifically indicated for cases where prior treatment with more than one antiviral agent (e.g., ganciclovir, valganciclovir, cidofovir, or foscarnet) has failed or is not tolerated .
2. Dosage and Administration
Route of Administration:
For Oral Use ONLY. Can be taken with or without food.
Recommended Dosage:
Standard Adult Dose: 400 mg (two 200 mg tablets) twice daily.
Duration: The duration of treatment is determined by the physician based on the clinical response and viral load.
Dose Adjustments:
With Anticonvulsants: If co-administered with carbamazepine, increase dose to 800 mg twice daily. If co-administered with phenytoin or phenobarbital, increase dose to 1200 mg twice daily .
Administration Instructions:
Tablets can be swallowed whole, dispersed in water, or crushed and administered via nasogastric (NG) or orogastric (OG) tubes .
3. Mechanism of Action
UL97 Kinase Inhibition:
Maribavir is a selective inhibitor of the human CMV (HCMV) pUL97 protein kinase.
Inhibition of Viral Replication:
By inhibiting pUL97, Maribavir interferes with viral DNA synthesis and the nuclear egress of viral capsids, thereby blocking viral replication .
4. Safety and Warnings
Antagonism with Ganciclovir/Valganciclovir:
Maribavir may antagonize the antiviral activity of ganciclovir and valganciclovir by inhibiting the UL97 kinase enzyme required for their phosphorylation (activation). Concomitant use is not recommended .
Taste Disturbance:
Dysgeusia (altered taste) is a very common side effect. Patients should be advised that food may taste metallic or unpleasant .
Drug Interactions:
Maribavir is a P-gp substrate. It may increase the concentrations of co-administered P-gp substrates (e.g., mycophenolate mofetil, tacrolimus, sirolimus). Therapeutic drug monitoring of these immunosuppressants is required .
5. Adverse Reactions
Most Common:
General: Dysgeusia (taste disturbance) – reported in up to 46% of patients, Nausea, Diarrhea, Vomiting, Fatigue, Pyrexia.
Laboratory Abnormalities: Neutropenia, Anemia, Thrombocytopenia, Increased creatinine .
6. Drug Interactions
CYP3A Substrate:
Maribavir is metabolized by CYP3A4. Strong CYP3A inducers (e.g., Rifampin) should be avoided as they decrease Maribavir exposure.
P-gp Substrate:
Maribavir is a P-gp substrate and can increase plasma concentrations of P-gp substrates (e.g., Digoxin, Immunosuppressants).
Anticonvulsants:
Strong inducers (Carbamazepine, Phenytoin, Phenobarbital) significantly reduce Maribavir levels, necessitating dose escalation as noted above .
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Maribavir.
Appearance: Blue, oval, convex film-coated tablets, debossed with “SHP” on one side and “620” on the other .
Storage: Store at 20°C–25°C (68°F–77°F); excursions permitted to 15°C–30°C (59°F–86°F) .