Velpanat Dosage/Direction for Use

Sofosbuvir and Velpatasvir tablets treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection.
Posology: The recommended dose of Sofosbuvir and Velpatasvir tablets is one tablet, taken orally, once daily with or without food (see Pharmacology: Pharmacokinetics under Actions). (See Table 14.)

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When used in combination with ribavirin, refer also to the Prescribing information of the medicinal product containing ribavirin.
The following dosing is recommended where ribavirin is divided in two daily doses and given with food: See Table 15.

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If ribavirin is used in genotype 3 infected patients with compensated cirrhosis (pre- or post-transplant) the recommended dose of ribavirin is 1,000/1,200 mg (1,000 mg for patients weighing < 75 kg and 1,200 mg for patients weighing ≥ 75 kg).
For ribavirin dose modifications, refer to the prescribing information of the medicinal product containing ribavirin.
Patients should be instructed that if vomiting occurs within 3 hours of dosing an additional tablet of Sofosbuvir and Velpatasvir tablets should be taken. If vomiting occurs more than 3 hours after dosing, no further dose of Sofosbuvir and Velpatasvir tablets is needed (see Pharmacology: Pharmacodynamics under Actions).
If a dose of Sofosbuvir and Velpatasvir tablets 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 Sofosbuvir and Velpatasvir tablets at the usual time. Patients should be instructed not to take a double dose of Sofosbuvir and Velpatasvir tablets.
Patients who have previously failed therapy with an NS5A-containing regimen: Sofosbuvir and Velpatasvir tablets + 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 Sofosbuvir and Velpatasvir tablets is required for patients with mild or moderate renal impairment. The safety and efficacy of Sofosbuvir and Velpatasvir tablets has not been assessed in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m²) or end stage renal disease (ESRD) requiring haemodialysis (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No dose adjustment of Sofosbuvir and Velpatasvir tablets 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 Sofosbuvir and Velpatasvir tablets have been assessed in patients with CPT Class B cirrhosis, but not in patients with CPT Class C cirrhosis (see Precautions, Adverse Reactions and Pharmacology: Pharmacodynamics under Actions).
Paediatric population: The safety and efficacy of Sofosbuvir and Velpatasvir tablets 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 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.