EPCLUSA TABLET 400MG/100MG [SIN15351P]

Product Info

EPCLUSA TABLET 400MG/100MG

[SIN15351P]

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).

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).

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.

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).