LIVTENCITY FILM-COATED TABLET 200MG

Catalent CTS, LLC (UNITED STATES)Takeda Ireland Limited (IRELAND)🇸🇬 Health Sciences Authority

Approval Date: Mar 18, 2025
Approval ID: 77cb0737029fc1f3
Company: Catalent CTS, LLC (UNITED STATES)Takeda Ireland Limited (IRELAND)
Type: Therapeutic

Approval Details

Approval Id: 77cb0737029fc1f3
Drug Name: LIVTENCITY FILM-COATED TABLET 200MG
Product Name: LIVTENCITY FILM-COATED TABLET 200MG
Approval Number: SIN17208P
Approval Date: 2025-03-18
Registrant: TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
Licence Holder: TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: TABLET, FILM COATED
Dosage: 4.2 Posology and Method of Administration Posology <img src="/TGIF/Livtencity-Table1.png" alt="Livtencity Dosage Table 1" /> 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.
Route Of Administration: ORAL
Indication Info: 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).
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).
Atc Code: J05AX10
Pharma Manufacturer Name: TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.

Active Ingredients

Maribavir

200mg

Maribavir

200mg

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Mar 18, 2025

Approval ID

77cb0737029fc1f3

Type

Therapeutic

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