Summary of drug instructions and precautions for long-term use of Bituvi/Bikernoprenol Tablets

1. Common name: Bictegravir Sodium/Emtricitabine/ Tenofovir

Alafenamide Fumarate

Product name: Biktarvy,Biktarvy

Other names: Tafik, Bicronol, BIC/FTC/TAF

2. Indications:

Bictegravir Sodium/Emtricitabine/Tenofovir Alafenamide Fumarate is a complete solution for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.

1. Adult and pediatric patients weighing at least14 kg;

2. No history of antiretroviral treatment;

3. In patients who are virologically suppressed (HIV-1 RNA less than 50 copies/mL), replace current antiretroviral therapy with stable antiretroviral therapy that has no known or suspected association with resistance to bitegravir or tenofovir.

3. Usage and dosage:

1. Testing at the beginning and during treatment with BITOVIL: Patients should be tested for hepatitis B virus infection before or when starting to use BITOVIL. Assess all patients for serum creatinine, estimated creatinine clearance, urine glucose, and urine protein before or at the time of initiating BITOVIR, and during treatment with BITOVIR, to meet clinical requirements. Serum phosphorus should also be assessed in patients with chronic kidney disease.

2. Recommended dosage for adult and pediatric patients weighing at least 25kg: Bitegravir is a fixed-dose combination product of three drugs, including bitegravir (BIC), emtricitabine (FTC) and tenofovir alafenamide (TAF). The recommended dose of BITOVIL is one tablet containing 50 mg BIC, 200 mg FTC, and 25 mg TAF, taken once daily with or without food:

(1) Adult and pediatric patients weighing at least 25kg and with estimated creatinine clearance ≥30mL/min; or

(2) In virologically suppressed adults receiving long-term hemodialysis, the estimated creatinine clearance is less than 15 mL/min. On hemodialysis days, take your daily dose of BITOVIL after completing your hemodialysis treatment.

3. Recommended dose for pediatric patients weighing at least 14 kg and < 25 kg: The recommended dose of BITOVIL is one tablet containing 30 mg BIC, 120 mg FTC and 15 mg TAF, taken once daily, with or without food, under the following conditions: Pediatric patients weighing at least 14 kg to less than 25 kg and with an estimated creatinine clearance ≥ 30 mL/min. For children who cannot swallow the whole tablet, the tablet can be divided and each part taken separately as long as all parts are swallowed in about 10 minutes.

4. Recommended dosage for pregnant women: The recommended dosage for BITOVIL in pregnant individuals is one tablet containing 50 mg BIC, 200 mg FTC, and 25 mg TAF and who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) while taking stable antiretroviral therapy. ), and there are no known surrogates associated with resistance to any of the individual components of BITOVIL, take orally once daily with or without food. Lower BIKTARVY exposure has been observed during pregnancy; therefore, viral load should be monitored closely.

5. Not recommended for patients with severe renal or liver damage.

4. Adverse reactions:

The most common side effects of Bituvit are headache, diarrhea, and nausea (feeling sick).

5. Supply and storage:

Bituvi tablets are available in bottles and blister packs. Store the bottles ([50mg/200mg/25mg tablets], [30mg/120mg/15mg]) in 3 Below 0°C (86°F); store blister packs (50mg/200mg/25mg tablets) at 25°C (77°F), excursions allowed within 15-30°C (59-86°F).

Reference materials:https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=664cb8f0-1f65-441b-b0d9-ba3d798be309#S12.4