HIGHLIGHTS OF PRESCRIBING INFORMATION

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

INDICATIONS AND USAGE

LuciTeno is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor and is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 6 years of age and older and weighing at least 25 kg with compensated liver disease.

DOSAGE AND ADMINISTRATION

• Testing: Prior to initiation of LuciTeno, test patients for HIV infection. LuciTeno alone should not be used in patients with HIV infection. Prior to or when initiating LuciTeno, and during treatment on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. Also assess serum phosphorus in patients with chronic kidney disease.

• Recommended dosage: 25 mg (one tablet) taken orally once daily with food.

• Renal Impairment: LuciTeno is not recommended in patients with estimated creatinine clearance below 15 mL per minute who are not receiving chronic hemodialysis. In patients on chronic hemodialysis, on hemodialysis days, administer LuciTeno after hemodialysis.

• Hepatic Impairment: LuciTeno is not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment.

DOSAGE FORMS AND STRENGTHS

Tablets: 25 mg×30 tablets

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

• HBV and HIV-1 coinfection: LuciTeno alone is not recommended for the treatment of HIV-1 infection. HIV-1 resistance may develop in these patients.

• New onset or worsening renal impairment: Prior to or when initiating LuciTeno, and during treatment on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. Also assess serum phosphorus in patients with chronic kidney disease.

• Lactic acidosis/severe hepatomegaly with steatosis: Discontinue treatment in patients who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.

ADVERSE REACTIONS

Most common adverse reaction (incidence greater than or equal to 10%, all grades) is headache.

DRUG INTERACTIONS

LuciTeno is a substrate of P-glycoprotein (P-gp) and BCRP. Drugs that strongly affect P-gp and BCRP activity may lead to changes in LuciTeno absorption. Consult the full prescribing information prior to and during treatment for potential drug-drug interactions.

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.