HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LuciSoVe safely and effectively. See full prescribing information for LuciSoVe.

INDICATIONS AND USAGE

LuciSoVe is a fixed-dose combination of sofosbuvir, a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor, and velpatasvir, an HCV NS5A inhibitor, and is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection :

• without cirrhosis or with compensated cirrhosis.

• with decompensated cirrhosis for use in combination with ribavirin.

DOSAGE AND ADMINISTRATION

• Recommended dosage in adults: One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily with or without food.

• Recommended dosage in pediatric patients 3 years and older: Recommended dosage is based on weight. Refer to Table 2 of the full prescribing information for specific dosing guidelines based on

body weight.

• For treatment-naïve and treatment-experienced liver transplant recipients without cirrhosis or with compensated cirrhosis (ChildPugh A), the recommended regimen is LuciSoVe once daily for 12 weeks.

• If used in combination with ribavirin, follow the recommendations for ribavirin dosing and dosage modifications.

DOSAGE FORMS AND STRENGTHS

Tablets: 400 mg/100mg×28 tablets

CONTRAINDICATIONS

LuciSoVe and ribavirin combination regimen is contraindicated in patients for whom ribavirin is contraindicated.

WARNINGS AND PRECAUTIONS

• Risk of Hepatitis B Virus Reactivation: Test all patients for evidence of current or prior HBV infection before initiation of HCV treatment. Monitor HCV/HBV coinfected patients for HBV reactivation and hepatitis flare during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.

• Bradycardia with amiodarone coadministration: Serious symptomatic bradycardia may occur in patients taking amiodarone, particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease. Coadministration of amiodarone with LuciSoVe is not recommended. In patients without alternative viable treatment options, cardiac monitoring is recommended.

ADVERSE REACTIONS

• The most common adverse reactions (incidence greater than or equal to 10%, all grades) observed in adults and pediatric subjects 6 years of age and older with treatment with LuciSoVe for 12 weeks are headache and fatigue.

• The most common adverse reactions (incidence greater than or equal to 10%, grade 1 or 2) observed in pediatric subjects less than 6 years of age are vomiting and product use issue (spitting up the drug).

• The most common adverse reactions (incidence greater than or equal to 10%, all grades) observed with treatment with LuciSoVe and ribavirin for 12 weeks in adult patients with decompensated cirrhosis are fatigue, anemia, nausea, headache, insomnia, and diarrhea.

DRUG INTERACTIONS

• P-gp inducers and/or moderate to strong CYP inducers (e.g., rifampin, St. John’s wort, carbamazepine): May decrease concentrations of sofosbuvir and/or velpatasvir. Use of LuciSoVe with P-gp inducers and/or moderate to strong CYP inducers is not recommended.

• Consult the full prescribing information prior to use for potential drug interactions.

• Clearance of HCV infection with direct acting antivirals may lead to changes in hepatic function, which may impact safe and effective use of concomitant medications. Frequent monitoring of relevant laboratory parameters (INR or blood glucose) and dose adjustments of certain concomitant medications may be necessary.

USE IN SPECIFIC POPULATIONS

See full prescribing information for LuciSoVe.

Storage

Store at 20℃ to 25℃ (68℉ to 77℉), excursions permitted between 15℃ and 30℃ (59℉ and 86℉) [see USP Controlled Room Temperature]. Protect from moisture.