LIVTENCITY FILM-COATED TABLET 200MG [SIN17208P]

Product Info

LIVTENCITY FILM-COATED TABLET 200MG

[SIN17208P]

Indication

4.1 Therapeutic Indications

Treatment of adults with post-transplant cytomegalovirus (CMV) infection/disease, who are refractory (with or without genotypic resistance) or intolerant to one or more prior therapies (see 4.3 CONTRAINDICATIONS, 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE and 5.1 PHARMACODYNAMIC PROPERTIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Dosing

4.2 Posology and Method of Administration

Posology

Treatment duration may need to be individualized based on the clinical characteristics of each patient.
In Study 303, 400 mg (two 200 mg tablets) twice daily of LIVTENCITY was administered for 8 weeks. LIVTENCITY doses up to 1200 mg twice daily were well tolerated for up to 24 weeks in Phase 2 studies (see Pharmacodynamic Properties, 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Dosage Adjustment

Dosage Adjustment When Co-administered with Anticonvulsants
If LIVTENCITY is co-administered with carbamazepine, increase the dosage of LIVTENCITY to 800 mg twice daily (see Interaction with Other Medications and Other Forms of Interaction, 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

If LIVTENCITY is co-administered with phenytoin or phenobarbital, increase the dosage of LIVTENCITY to 1,200 mg twice daily (see Interaction with Other Medications and Other Forms of Interaction, 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Dosage Adjustment When Co-administered with Antimycobacterials
If LIVTENCITY is co-administered with rifabutin, increase the dosage of LIVTENCITY to 800 mg twice daily (see Interaction with Other Medications and Other Forms of Interaction, 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Dosage Adjustment When Co-administered with Antiretroviral agents
If LIVTENCITY is co-administered with efavirenz, increase the dosage of LIVTENCITY to 1,200 mg twice daily (see Interaction with Other Medications and Other Forms of Interaction, 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Special Patient Populations

Elderly Patients
No dose adjustment is required for patients over 65 years of age.

Pediatric Patients
The safety and efficacy of LIVTENCITY in patients below 18 years of age have not been established.

Impaired Renal Function
No dose adjustment of LIVTENCITY is needed for patients with mild, moderate, or severe renal impairment. Administration of LIVTENCITY in patients with end stage renal disease (ESRD), including patients on dialysis, has not been studied (see Pharmacokinetic Properties, 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Impaired Hepatic Function
No dose adjustment of LIVTENCITY is needed for patients with mild (Child-Pugh Class A) or moderate hepatic impairment (Child-Pugh Class B). Administration of LIVTENCITY in patients with severe hepatic impairment (Child-Pugh Class C) has not been studied (see Pharmacokinetic Properties, 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Method of Administration
LIVTENCITY is intended for oral use only and can be taken with or without food. The immediate-release tablet can be taken as a whole, dispersed, or crushed tablets by mouth, or as dispersed tablets through nasogastric or orogastric tube.

Contraindications

4.3 Contraindications

LIVTENCITY is contraindicated in individuals with known hypersensitivity to LIVTENCITY or any components of the formulation.
Coadministration of LIVTENCITY with ganciclovir or valganciclovir is contraindicated. LIVTENCITY may antagonize the antiviral effect of ganciclovir and valganciclovir by inhibiting human CMV UL97 serine/threonine kinase, which is required for activation/phosphorylation of ganciclovir and valganciclovir (see Interaction with Other Medications and Other Forms of Interaction, 4.5 and Pharmacokinetic Properties, 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).