Livtencity

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE LIVTENCITY ® is indicated for the treatment of adults and pediatric patients (12 years of age and older and weighing at least 35 kg) with post-transplant cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet [see Use in Specific Populations (8.4) and Clinical Studies (14) ] . LIVTENCITY is a cytomegalovirus (CMV) pUL97 kinase inhibitor indicated for the treatment of adults and pediatric patients (12 years of age and older and weighing at least 35 kg) with post-transplant CMV infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet. ( 1 , 8.4 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION 400 mg (two 200 mg tablets) orally twice daily with or without food. ( 2.1 , 8.4 ) 2.1 Recommended Dosage The recommended dosage in adults and pediatric patients (12 years of age and older and weighing at least 35 kg) is 400 mg (two 200 mg tablets) taken orally twice daily with or without food [see Use in Specific Populations (8.4) , Clinical Pharmacology (12.3) and Clinical Studies (14) ] . 2.2 Dosage Adjustment When Coadministered with Anticonvulsants If LIVTENCITY is coadministered with carbamazepine, increase the dosage of LIVTENCITY to 800 mg (four 200 mg tablets) twice daily [see Drug Interactions (7.3) and Clinical Pharmacology (12.3) ] . If LIVTENCITY is coadministered with phenytoin or phenobarbital, increase the dosage of LIVTENCITY to 1,200 mg (six 200 mg tablets) twice daily [see Drug Interactions (7.3) and Clinical Pharmacology (12.3) ] . 2.3 Dosage Adjustment When Coadministered with Rifabutin If LIVTENCITY is co-administered with rifabutin, increase the dosage of LIVTENCITY to 800 mg (four 200 mg tablets) twice daily [see Drug Interactions (7.3) and Clinical Pharmacology (12.3) ] . 2.4 Administration Instructions The immediate-release tablets can be taken as whole, dispersed or crushed tablets by mouth, or as dispersed tablets through a nasogastric or orogastric tube (French size 10 or larger). The suspension may be prepared ahead of time and stored at room temperature for up to 8 hours. Administration of Dispersed Tablets or Crushed Tablets by Mouth Place the appropriate number of tablets for the prescribed dose into a suitable container. If desired, the tablets may be crushed. Add the appropriate volume of drinking water (other liquids have not been tested) to make a suspension (see Table 1 below) . Table 1: Number of Tablets and Volume of Drinking Water Needed to Make a Suspension for Administration of Dispersed or Crushed Tablets by Mouth Recommended Dosage Number of 200 mg Tablets Volume of Drinking Water 400 mg Two 30 mL 800 mg Four 60 mL 1,200 mg Six 90 mL Swirl the container gently to keep the particles from settling, and administer the suspension before it settles. The mixture will have a bitter taste. Rinse the container with 15 mL of drinking water and administer the rinse water. Repeat Step 3. Visually confirm that no particles are left in the container. If particles remain, repeat Step 3. Administration of Dispersed Tablets through a Nasogastric (NG) or Orogastric (OG) Tube Remove the cap (if applicable) and plunger out of a 50 or 60 mL catheter-tip compatible syringe or equivalent. Add two tablets into the syringe body and place the plunger back in the syringe. Only two tablets can be administered via NG or OG tube at a time. Draw 30 mL of drinking water (other liquids have not been tested) into the syringe and hold the syringe with the tip pointing upward. Pull the plunger further to a higher volume position to have some air space in the syringe. Place the cap back on the syringe (if applicable). Shake the syringe well (careful not to spill the contents) for about 30 to 45 seconds or until the tablets are completely dispersed. Once the tablets are completely dispersed in the syringe, remove the cap from the syringe again (if applicable) and attach the syringe to the NG or OG tube and administer the dispersion before it settles. Draw 15 mL of water using the same syringe and flush through the same NG or OG tube. Repeat Step 4 and make sure no particles are left in the syringe by visual inspection. If particles remain, repeat Step 4. For doses of 800 mg (four 200 mg tablets) and 1,200 mg (six 200 mg tablets) [see Dosage and Administration (2.2 , 2.3) ] , repeat Steps 1-5 until prescribed dose is reached. The same syringe, NG or OG tube can be used. Warnings and cautions 5 WARNINGS AND PRECAUTIONS LIVTENCITY may antagonize the antiviral activity of ganciclovir and valganciclovir. Coadministration is not recommended. ( 5.1 , 7.1 ) Virologic failure can occur during and after treatment with LIVTENCITY. Monitor CMV DNA levels and check for resistance if patient does not respond to treatment. Some maribavir pUL97 resistance-associated substitutio