Regulatory Information
GILEAD SCIENCES SINGAPORE PTE. LTD.
GILEAD SCIENCES SINGAPORE PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
TABLET, FILM COATED
**4.2 Posology and method of administration** Vosevi treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection. Posology The recommended dose of Vosevi is one tablet, taken orally, once daily with food (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The recommended durations of treatment applicable to all HCV genotypes are shown in Table 1.  _Missed dose_ If a dose of Vosevi 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 Vosevi at the usual time. Patients should be instructed not to take a double dose of Vosevi. Patients should be instructed that if vomiting occurs within 4 hours of dosing, an additional tablet of Vosevi should be taken. If vomiting occurs more than 4 hours after dosing, no further dose of Vosevi is needed (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _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 Vosevi 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. Vosevi has not been studied in patients with ESRD requiring dialysis. Vosevi can be used in these patients with no dose adjustment when no other relevant treatment options are available (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 Vosevi is required for patients with mild hepatic impairment (Child-Pugh-Turcotte \[CPT\] Class A). Vosevi is not recommended in patients with moderate or severe hepatic impairment (CPT Class B or C) or those with any history of prior hepatic decompensation (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Paediatric population_ The safety and efficacy of Vosevi in children and adolescents aged less than 18 years have not yet been established. No data are available. Method of administration For oral use. Patients should be instructed to swallow the tablet whole with 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.
ORAL
Medical Information
**4.1 Therapeutic indications** Vosevi is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults (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_).
**4.3 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_. Concomitant use with medicinal products that are strong P-glycoprotein (P-gp) and/or strong cytochrome P450 (CYP) inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin and St. John’s wort) (see section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Concomitant use with rosuvastatin or dabigatran etexilate (see section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Concomitant use with ethinylestradiol-containing medicinal products such as combined oral contraceptives or contraceptive vaginal rings (see section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
J05AP56
sofosbuvir, velpatasvir and voxilaprevir
Manufacturer Information
GILEAD SCIENCES SINGAPORE PTE. LTD.
Gilead Sciences Ireland UC
Hovione FarmaCiencia, S.A. (Drug product intermediate)
Hovione Limited (Drug product intermediate)
Active Ingredients
Documents
Package Inserts
Vosevi Tablet PI.pdf
Approved: September 18, 2020