EPCLUSA TABLET 400MG/100MG

HOVIONE FARMACIENCIA, S.A. (DRUG PRODUCT INTERMEDIATE) - PORTUGALHOVIONE LIMITED (DRUG PRODUCT INTERMEDIATE) - IRELANDPATHEON INC. - CANADAGILEAD SCIENCES IRELAND UC - IRELANDESTEVE QUIMICA S.A. (DRUG PRODUCT INTERMEDIATE) (SPAIN)🇸🇬 Health Sciences Authority

Approval Date: Oct 19, 2017
Approval ID: ed02da053cd02d6c
Company: HOVIONE FARMACIENCIA, S.A. (DRUG PRODUCT INTERMEDIATE) - PORTUGALHOVIONE LIMITED (DRUG PRODUCT INTERMEDIATE) - IRELANDPATHEON INC. - CANADAGILEAD SCIENCES IRELAND UC - IRELANDESTEVE QUIMICA S.A. (DRUG PRODUCT INTERMEDIATE) (SPAIN)
Type: Therapeutic

Approval Details

Approval Id: ed02da053cd02d6c
Drug Name: EPCLUSA TABLET 400MG/100MG
Product Name: EPCLUSA TABLET 400MG/100MG
Approval Number: SIN15351P
Approval Date: 2017-10-19
Registrant: GILEAD SCIENCES SINGAPORE PTE. LTD.
Licence Holder: GILEAD SCIENCES SINGAPORE PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: TABLET, FILM COATED
Dosage: 4.2 Posology and method of administration Epclusa treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection. Posology The recommended dose of Epclusa in adults is one 400 mg/100 mg tablet, taken orally, once daily with or without food as detailed in Table 1 (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The recommended dose of Epclusa in patients aged 12 to < 18 years and weighing at least 30 kg is one 400 mg/100 mg tablet, taken orally, once daily with or without food for 12 weeks (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). <img src="/TGIF/Epclusa-Table1_211221.png" alt="Epclusa Dosage Table 1" /> Patients should be instructed that if vomiting occurs within 3 hours of dosing an additional tablet of Epclusa should be taken. If vomiting occurs more than 3 hours after dosing, no further dose of Epclusa is needed (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). If a dose of Epclusa is missed and it is within 18 hours of the normal time, patients should be instructed to take the tablet as soon as possible and then patients should take the next dose at the usual time. If it is after 18 hours then patients should be instructed to wait and take the next dose of Epclusa at the usual time. Patients should be instructed not to take a double dose of Epclusa. Elderly No dose adjustment is warranted for elderly patients (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Renal impairment No dose adjustment of Epclusa is required for patients with mild or moderate renal impairment. Safety data are limited in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2) and end stage renal disease (ESRD) requiring haemodialysis. Epclusa can be used in these patients with no dose adjustment (see section 4.4, 4.8, 5.1 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Hepatic impairment No dose adjustment of Epclusa is required for patients with mild, moderate, or severe hepatic impairment (CPT Class A, B, or C) (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Safety and efficacy of Epclusa have been assessed in adult patients with CPT Class B cirrhosis, but not in patients with CPT Class C cirrhosis (see sections 4.4, 4.8 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Paediatric population The safety and efficacy of Epclusa in children aged less than 12 years or weighing less than 30 kg have not yet been established. Method of administration For oral use. Patients should be instructed to swallow the tablet whole with or without food (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Due to the bitter taste, it is recommended that the film-coated tablet is not chewed or crushed.
Route Of Administration: ORAL
Indication Info: 4.1 Therapeutic indications Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients aged 12 years and older and weighing at least 30kg (see sections 4.2, 4.4 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Contraindications: 4.3 Contraindications Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. Use with strong P-gp and strong CYP inducers Medicinal products that are strong P-glycoprotein (P-gp) and/or strong cytochrome P450 (CYP) inducers (carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin and St. John’s wort). Co-administration will significantly decrease sofosbuvir or velpatasvir plasma concentrations and could result in loss of efficacy of Epclusa (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Atc Code: J05AP55
Atc Item Name: sofosbuvir and velpatasvir
Pharma Manufacturer Name: GILEAD SCIENCES SINGAPORE PTE. LTD.

Active Ingredients

Velpatasvir

100mg

Sofosbuvir

400mg

SOFOSBUVIR

400 MG

VELPATASVIR

100 MG

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Oct 19, 2017

Approval ID

ed02da053cd02d6c

Type

Therapeutic

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