Epclusa Dosage/Direction for Use

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 (see Pharmacology: Pharmacokinetics under Actions). (See Table 16.)
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 (see Pharmacology: Pharmacokinetics under Actions). (See Table 18.)

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When used in combination with ribavirin, refer also to the Summary of Product Characteristics of the medicinal product containing ribavirin.
The following dosing is recommended for adults where ribavirin is divided in two daily doses and given with food: See Table 17.

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If ribavirin is used in genotype 3 infected adult patients with compensated cirrhosis (pre- or post-transplant), the recommended dose of ribavirin is 1,000/1,200 mg (1,000 mg for adult patients weighing <75 kg and 1,200 mg for adult patients weighing ≥75 kg).
For ribavirin dose modifications, refer to the Summary of Product Characteristics of the medicinal product containing ribavirin.

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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 Pharmacology: Pharmacodynamics under Actions).
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.
Adult patients who have previously failed therapy with an NS5A-containing regimen: Epclusa + ribavirin for 24 weeks may be considered (see Precautions).
Elderly: No dose adjustment is warranted for elderly patients (see Pharmacology: Pharmacokinetics under Actions).
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 when no other relevant treatment options are available (see Precautions and Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
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 Pharmacology: Pharmacokinetics under Actions). Safety and efficacy of Epclusa have been assessed in patients with CPT Class B cirrhosis, but not in patients with CPT Class C cirrhosis (see Precautions and Pharmacology: Pharmacodynamics under Actions).
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 Pharmacology: Pharmacokinetics under Actions). Due to the bitter taste, it is recommended that the film-coated tablet is not chewed or crushed.