BIXLENVO

BIXLENVO is an FDA-registered drug product whose active ingredient is BICTEGRAVIR/LENACAPAVIR. It is labelled by Gilead Sciences, Inc. taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 61958-3601, application NDA221104, label effective 20260827. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing BICTEGRAVIR/LENACAPAVIR are most often described in connection with: antiretroviral regimen, indicated complete, human immunodeficiency, virus type, adults replace, virologically suppressed, hiv- rna, known suspected. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE BIXLENVO is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults 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 resistance to the individual components of BIXLENVO [see Clinical Studies (14) ] . BIXLENVO, a two-drug combination of bictegravir (BIC), a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI), and lenacapavir (LEN), an HIV-1 capsid inhibitor, is indicated as a complete regimen for the treatment of HIV-1 in adults 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 resistance to the individual components of BIXLENVO.

2 DOSAGE AND ADMINISTRATION Recommended Dosage: Two-day initiation regimen of BIXLENVO plus oral SUNLENCA ® , followed by a maintenance regimen of BIXLENVO. Tablets may be taken with or without food. ( 2.1 ) Treatment Time Dosage: Initiation Day 1 BIXLENVO 75 mg/50 mg (1 tablet) orally and SUNLENCA 600 mg orally (2 × 300 mg tablets) Day 2 BIXLENVO 75 mg/50 mg (1 tablet) orally and SUNLENCA 600 mg orally (2 × 300 mg tablets) Dosage: Maintenance Day 3 and thereafter BIXLENVO 75 mg/50 mg (1 tablet) orally once daily Missed dose: Patients should take missed initiation or maintenance doses as soon as possible. If more than 7 days have elapsed since the last maintenance dose, restart initiation dosage regimen from Day 1, if clinically appropriate to continue BIXLENVO. ( 2.2 ) 2.1 Recommended Dosage The BIXLENVO dosing schedule in adults requires a two-day initiation regimen of BIXLENVO tablets plus SUNLENCA tablets taken orally, followed by a maintenance regimen of one tablet of BIXLENVO taken orally once daily ( Table 1 ). BIXLENVO must be taken with SUNLENCA during the two-day initiation period. BIXLENVO and SUNLENCA tablets may be taken with or without food [see Clinical Pharmacology (12.3) ] . Table 1 Recommended Treatment Regimen for BIXLENVO Initiation and Maintenance Treatment Time Dosage: Initiation Day 1 BIXLENVO 75 mg/50 mg (1 tablet) orally and SUNLENCA 600 mg orally (2 × 300 mg tablets) Day 2 BIXLENVO 75 mg/50 mg (1 tablet) orally and SUNLENCA 600 mg orally (2 × 300 mg tablets) Dosage: Maintenance Day 3 and thereafter BIXLENVO 75 mg/50 mg (1 tablet) orally once daily 2.2 Recommended Dosing Schedule for Missed Dose Missed Initiation Dose During the initiation period, if the Day 1 or Day 2 doses of BIXLENVO or SUNLENCA are missed, patients should take them as soon as possible (see Table 1 ). Patients should not take Day 1 and Day 2 doses of SUNLENCA on the same day. Missed Maintenance Dose If a maintenance dose of BIXLENVO is missed, patients should take it as soon as possible. If more than 7 days have elapsed since the last maintenance dose, restart the initiation dosage regimen from Day 1, if clinically appropriate to continue BIXLENVO treatment (see Table 1 ). 2.3 BIXLENVO Use During Pregnancy Lower exposures of BIC were observed during pregnancy; therefore, viral load should be monitored closely in pregnant individuals [see Drug Interactions (7.4) , Use in Specific Populations (8.1) , and Clinical Pharmacology (12.3) ] .

4 CONTRAINDICATIONS Concomitant administration of BIXLENVO is contraindicated with: dofetilide due to the potential for increased dofetilide plasma concentrations and associated serious and/or life-threatening events. strong CYP3A inducers due to decreased plasma concentrations of BIC and LEN, which may result in the loss of therapeutic effect and development of resistance to BIXLENVO. Concomitant administration of BIXLENVO is contraindicated with: Dofetilide Strong CYP3A inducers. ( 4 )

6 ADVERSE REACTIONS Most common adverse reactions (incidence greater than or equal to 2%, all grades) are headache, nausea, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The primary safety assessment of BIXLENVO in virologically suppressed adults with HIV-1 was based on 48-week data from participants in two Phase 3 randomized active-controlled clinical trials, ARTISTRY-1 (N=557) and ARTISTRY-2 (N=574) [see Clinical Studies (14) ] . ARTISTRY-1 was an open-label trial that enrolled participants who had been on a stable baseline regimen for at least 6 months and were randomized to receive BIXLENVO or to continue their stable baseline regimen. ARTISTRY-2 was a blinded trial that enrolled participants who had been on BIKTARVY for at least 6 months at baseline and were randomized to receive BIXLENVO or to continue BIKTARVY. The most common adverse reactions (all grades) reported in greater than or equal to 2% of participants in any treatment group from ARTISTRY-1 and ARTISTRY-2 through Week 48 are presented in Table 2 . The side-by-side tabulation is to simplify presentation; direct comparison across trials should not be made due to differing trial designs. Table 2 Adverse Reactions Frequencies of adverse reactions are based on all adverse events attributed to trial drugs by the investigator. (All Grades) Reported in ≥ 2% of Adults with HIV-1 Receiving BIXLENVO in Trials ARTISTRY-1 or ARTISTRY-2 (Week 48 Analysis). ARTISTRY-1 ARTISTRY-1 was open-label with a stable baseline regimen as the comparator. ARTISTRY-2 ARTISTRY-2 was blinded with BIKTARVY as the comparator. Adverse Reactions BIXLENVO N=371 Stable Baseline Regimen N=186 BIXLENVO N=383 BIKTARVY N=191 Headache 4% 0 1% 0 Nausea 3% 0 3% 4% Diarrhea 2% 0 2% 2% Laboratory Abnormalities Changes in Serum Creatinine BIC has been shown to increase serum creatinine due to inhibition of tubular secretion of creatinine without affecting renal glomerular function [see Clinical Pharmacology 12.2 ]. ALT and AST Elevations ALT and AST abnormalities from ARTISTRY-1 and ARTISTRY-2 trials are presented in Table 3 . Table 3 ALT and AST Abnormalities (All Grades) in ARTISTRY-1 or ARTISTRY-2 (Week 48 Analyses) ARTISTRY-1 Frequencies are based on treatment-emergent laboratory abnormalities. ARTISTRY-2 Laboratory Parameter Abnormality BIXLENVO N=371 Stable Baseline Regimen N=186 BIXLENVO N=383 BIKTARVY N=191 ULN = Upper limit of normal Alanine Aminotransferase (ALT) Grade 1: 1.25 – <2.5 x ULN 12% 1% 5% 9% Grade 2: 2.5 – <5.0 x ULN 2% 1% 2% 1% Grade 3: 5.0 – <10.0 x ULN 0 0 1% 0 Grade 4: ≥10.0 x ULN <1% 0 <1% 0 Aspartate Aminotransferase (AST) Grade 1: 1.25 – <2.5 x ULN 10% 4% 5% 9% Grade 2: 2.5 – <5.0 x ULN 2% 2% 2% 2% Grade 3: 5.0 – <10.0 x ULN 1% 0 1% 0 Grade 4: ≥10.0 x ULN <1% 0 <1% 0 6.2 Postmarketing Experience The following adverse reactions have been identified during postmarketing experience in patients receiving a bictegravir-containing regimen. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Skin and Subcutaneous Tissue Disorders Angioedema, urticaria, and Stevens-Johnson syndrome/toxic epidermal necrolysis Investigations Weight increased

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is BIXLENVO used for?
1 INDICATIONS AND USAGE BIXLENVO is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults 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 resistance to the individual components of BIXLENVO [see …

Who makes BIXLENVO?
Gilead Sciences, Inc. is the labeler of record for BIXLENVO.

What form does BIXLENVO come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is BIXLENVO prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has BIXLENVO been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.