The complete version of the Chinese instructions and instructions for use of Bituvi/Bikernopinol Tablets

1. Common name: Bictegravir Sodium/Emtricitabine/Tenofovir Alafenamide Fumarate

Product name: Biktarvy,Biktarvy

Other names: Bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate

2. Indications:

Biktarvy is a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection (AIDS) in adults and pediatric patients weighing at least 14 kg:

(1) No history of antiretroviral treatment, or;

or

(3)In patients who are virologically suppressed (HIV-1 RNA less than 50 copies/mL), use stable antiretroviral therapy to replace current antiretroviral therapy, and there are no known or suspected substitution therapies associated with resistance to bitegravir or tenofovir.

3. Usage and dosage:

1. Before taking medicine:

(1) Test patients for hepatitis B virus infection before or when starting treatment.

(2) Assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients before or during initiation of dosing and as clinically appropriate during treatment. Serum phosphorus should also be assessed in patients with chronic kidney disease.

2. Recommended dosage:

(1) Adult and pediatric patients weighing at least 25kg

Bictegravir tablets are a three-drug fixed-dose combination product containing bictegravir sodium (BIC), emtricitabine (FTC) and tenofovir alafenamide fumarate (TAF). The recommended dose is one tablet containing 50 mg BIC, 200 mg FTC, and 25 mg TAF, taken by mouth once daily with or without food.

Weight at leastAdult and pediatric patients 25 kg and with an estimated creatinine clearance ≥30 mL/min; or virologically suppressed adults receiving chronic hemodialysis with an estimated creatinine clearance less than 15 mL/min. On hemodialysis days, take a daily dose of Bicronol tablets at the end of your hemodialysis treatment.

(2) Pediatric patients weighing at least14kg to less than 25kg:

The recommended dose is one tablet containing30 mg BIC, 120 mg FTC, and 15 mg TAF, taken orally once daily with or without food. For pediatric patients weighing at least 14 kg and less than 25 kg, estimated creatinine clearance is ≥30 mL/min. For children who are unable to swallow the whole tablet, the tablet can be divided and taken as long as all parts are taken within about 10 minutes.

3. Special groups

(1) Recommended dosage for pregnant women

The recommended dose of Bicanax is one tablet containing 50 mg BIC, 200 mg FTC, and 25 mg TAF taken orally once daily in pregnant women who are virologically suppressed (HIV-1 RNA less than 50 copies per milliliter) on a stable antiretroviral regimen. There are no known substitutions associated with resistance to any of the individual components of Bicanab. Lower exposure has been observed during pregnancy; therefore, viral load should be monitored closely.

(2) It is not recommended for patients with severe renal impairment: the following patients;

Severe renal impairment (estimated creatinine clearanceless than 15 to 30mL/min); or

End-stage renal disease (ESRD; estimated creatinine clearance less than 15mL/min, not receiving chronic hemodialysis;

Or patients with no history of antiretroviral treatment and receiving chronic hemodialysisESRD patients

(3) It is not recommended for patients with severe liver damage.

4. Adverse reactions:

Common adverse reactions in clinical studies of Bikeren Proprexil tablets include diarrhea, nausea and headache.

5. Supply and storage:

Bikronol tablets are available in bottles and blister packs. The bottles ([50mg/200mg/25mg tablets], [30mg/120mg/15mg]) can be stored in Below 30°C (86°F); blister packs (50mg/200mg/25mg tablets) may be stored at 25°C (77°F), excursions allowed within 15-30°C (59-86°F).

6. Taboo:

Bikernoprenol tablets are contraindicated in combination with the following drugs:

1. Dofetilide, as dofetilide plasma concentrations may increase and may cause serious and/or life-threatening events

2. Due to the decrease in BIC plasma concentration, rifampicin may lead to loss of therapeutic effect and the development of resistance to calvir.

7. Mechanism of action:

Bikernazepam contains three active substances that work against HIV in different ways:

1. Diletegravir is an antiviral agent called an "integrase inhibitor". It blocks an enzyme called integrase, which is necessary for the HIV virus to replicate itself in the body.

2. Emtricitabine is a nucleotide reverse transcriptase inhibitor (NRTI), which means it blocks the activity of reverse transcriptase, another enzyme of the virus that allows it to reproduce itself.

3. Tenofovir alafenamide is the "prodrug" of tenofovir, which means that it is converted into tenofovo's active substance in the body. Tenofovir is another NRTI that works in the same way as emtricitabine.

Bikran does not cure HIV-1 infection or AIDS, but it can prevent damage to the immune system and the development of AIDS-related infections and illnesses.

Reference materials:https://www.biktarvy.com/