INDICATIONS AND USAGE（适应症）

BIKTARVY is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (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 history of treatment failure and no known substitutions associated with resistance to the individual components of BIKTARVY.

DOSAGE（服用剂量）

Recommended Dosage in Adults and Pediatric Patients Weighing at Least 25 kg

BIKTARVY is a three-drug fixed dose combination product containing bictegravir (BIC), emtricitabine (FTC), and tenofovir alafenamide (TAF). The recommended dosage of BIKTARVY is one tablet containing 50 mg of BIC, 200 mg of FTC, and 25 mg of TAF taken orally once daily with or without food in:

adults and pediatric patients weighing at least 25 kg with an estimated creatinine clearance greater than or equal to 30 mL/min; or

virologically-suppressed adults with an estimated creatinine clearance below 15 mL/min who are receiving chronic hemodialysis. On days of hemodialysis, administer the daily dose of BIKTARVY after completion of hemodialysis treatment.

Recommended Dosage in Pediatric Patients Weighing at Least 14 kg to Less than 25 kg

The recommended dosage of BIKTARVY is one tablet containing 30 mg of BIC, 120 mg of FTC, and 15 mg of TAF taken orally once daily with or without food in:

pediatric patients weighing at least 14 kg to less than 25 kg with an estimated creatinine clearance greater than or equal to 30 mL/min.

ADVERSE REACTIONS（不良反应）

Severe Acute Exacerbations of Hepatitis B

Immune Reconstitution Syndrome

New Onset or Worsening Renal Impairment

Lactic Acidosis/Severe Hepatomegaly with Steatosis

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/664cb8f0-1f65-441b-b0d9-ba3d798be309/spl-doc?hl=Biktarvy

Tafficinformation