Indications for: LIVTENCITY
Post-transplant cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet.
Adults and Children:
<12yrs: not established. Tabs can be swallowed whole, dispersed or crushed (prepared in susp form); or as dispersed tabs (prepared in susp form) through a nasogastric or orogastric tube; see full labeling. ≥12yrs (≥35kg): 400mg twice daily. Concomitant carbamazepine: increase to 800mg twice daily. Concomitant phenytoin or phenobarbital: increase to 1200mg twice daily.
Virologic failure during treatment or relapse during posttreatment (within 4–8 weeks) after discontinuation may occur. Monitor CMV DNA levels and check for resistance if relapses or no treatment response. ESRD including dialysis, severe hepatic impairment: not studied. Pregnancy. Nursing mothers.
CMV pUL97 kinase inhibitor.
Concomitant ganciclovir, valganciclovir, CYP3A4 strong inducers (except for certain anticonvulsants; see Adults and Children): not recommended. Antagonized by rifabutin, rifampin, St. John’s wort: avoid concomitant use. May potentiate immunosuppressant drugs that are CYP3A and/or P-gp substrates (eg, tacrolimus, cyclosporine, sirolimus, everolimus); monitor levels frequently and adjust dose of substrate as needed. Caution with digoxin; monitor levels; may need to reduce digoxin dose. Potentiates rosuvastatin; monitor closely for myopathy and rhabdomyolysis.
Taste disturbance, nausea, diarrhea, vomiting, fatigue.
Generic Drug Availability: