Biktarvy (Bictegravir/Emtricitabine/TAF) – HIV-1 | HongKong DengYue Medicine

Biktarvy Application Scope

Biktarvy® is indicated for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 kg, including:

• Treatment-naïve patients

• Virologically suppressed patients (HIV-1 RNA <50 copies/mL) who are switching therapy, with no known resistance to the components of Biktarvy.

  

Biktarvy Characteristics

• Ingredients: Bictegravir/Emtricitabine/Tenofovir Alafenamide

• Properties:​ A single-tablet, fixed-dose combination antiretroviral agent consisting of:

  • One integrase strand transfer inhibitor (INSTI)

  • Two nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)

• Packaging Specification:​ Oral tablets, supplied in bottles or blister packs (packaging may vary by market)

• Storage:​ Store at or below 30°C (86°F)

• Expiry Date: Refer to the label on the original packaging

• Executive Standard: ​Manufactured in accordance with applicable pharmaceutical quality and regulatory standards

• Approval Number: NDA 210251 (U.S. FDA). Approval numbers vary by country/region

• Date of Revision: Please refer to the latest official prescribing information for the most current revision date. (e.g., May 2023 revision)

• Manufacturer: Gilead Sciences, Inc./Foster City, California 94404, USA

Guidelines for the Use of Biktarvy

• Dosage and Administration:

  • Recommended Dose: One tablet taken orally once daily.

  • Administration: Can be taken with or without food.

  • Missed Dose:​ If a dose is missed, take it as soon as it is remembered on the same day. If remembered on the next day, take the next dose at the regular time. Do not take two tablets on the same day to make up for a missed dose.

• Adverse Reactions:

  • Common Adverse Reactions:

    • Diarrhea

    • Nausea

    • Headache

    • Fatigue

  • Serious Adverse Reactions:

    • Lactic acidosis and severe hepatomegaly with steatosis

    • Worsening of hepatitis B after discontinuation

    • Severe renal impairment

    • Immune reconstitution inflammatory syndrome (IRIS)

    ​

• Contraindications:

  • Known hypersensitivity to any component of the product

  • Concomitant use with drugs that are strong inducers of CYP3A or UGT1A1 (e.g., rifampin)

• Precautions:

  • Assess renal and hepatic function before and during treatment

  • Monitor patients co-infected with HIV-1 and hepatitis B virus (HBV)

  • Use caution when co-administered with drugs affecting renal function

  • Not recommended in patients with severe hepatic impairment

Biktarvy Interactions

• Polyvalent cation–containing antacids or supplements may reduce bictegravir absorption

• Rifampin and certain anticonvulsants may decrease efficacy

• Review all concomitant medications prior to initiation

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
•  This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.