HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use LuciBet safely and effectively. See full prescribing information for LuciBet.
INDICATIONS AND USAGE
LuciBet is a three-drug combination of bictegravir (BIC), a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI), and emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV-1 nucleoside analog reverse transcriptase inhibitors (NRTIs), and is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 14 kg:
• who have no antiretroviral treatment history or
• to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir.
DOSAGE AND ADMINISTRATION
• Testing: Prior to or when initiating LuciBet test for hepatitis B virus infection. Prior to or when initiating LuciBet, and during treatment, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, also assess serum phosphorus.
• Recommended dosage in adults and pediatric patients weighing at least 25 kg, or virologically-suppressed adults with estimated creatinine clearance below 15 mL/min receiving chronic hemodialysis: One tablet containing 50 mg BIC, 200 mg FTC, and 25 mg TAF taken once daily with or without food.
• Recommended dosage in pediatric patients weighing at least 14 kg to less than 25 kg: One tablet containing 30 mg BIC, 120 mg FTC, and 15 mg TAF taken once daily with or without food.
• Recommended dosage in pregnant individuals who are virologicallysuppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known substitutions associated with resistance to the individual components of LuciBet: One tablet containing 50 mg BIC, 200 mg FTC, and 25 mg TAF taken orally once daily with or without food.
• Renal impairment: LuciBet is not recommended in patients with estimated creatinine clearance of 15 to below 30 mL/min, or below 15 mL/min who are not receiving chronic hemodialysis, or below 15 mL/min who have no antiretroviral treatment history.
• Hepatic impairment: LuciBet is not recommended in patients with severe hepatic impairment.
DOSAGE FORMS AND STRENGTHS
Tablets: 50/200/25 mg×30 tablets
CONTRAINDICATIONS
LuciBet is contraindicated to be co-administered with:
• dofetilide.
• rifampin.
WARNINGS AND PRECAUTIONS
• Immune reconstitution syndrome: May necessitate further evaluation and treatment.
• New onset or worsening renal impairment: Assess serum creatinine, estimated creatinine clearance, urine glucose and urine protein when initiating LuciBet and during therapy as clinically appropriate 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 reactions (incidence greater than or equal to 5%, all grades) are diarrhea, nausea, and headache.
DRUG INTERACTIONS
• Because LuciBet is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended.
• Consult the Full Prescribing Information prior to and during treatment for important drug interactions.
USE IN SPECIFIC POPULATIONS
• Pediatrics: Not recommended for patients weighing less than 14 kg.
Storage
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture.
