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warnings and cautions
5 WARNINGS AND PRECAUTIONS 5.1 Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions The concomitant use of BIXLENVO with certain other drugs may result in known or potentially significant drug interactions, some of which may lead to [see Contraindications (4) , and Drug Interactions (7.4) ]: Loss of therapeutic effect of BIXLENVO and possible development of resistance. Possible clinically significant adverse reactions from greater exposures of concomitant drugs. See Table 4 for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations. Consider the potential for drug interactions prior to and during BIXLENVO therapy; review concomitant medications during BIXLENVO therapy; and monitor for the adverse reactions associated with the concomitant drugs.
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
adverse reactions table
<table width="85%" ID="table2"><caption>Table 2 Adverse Reactions<footnote ID="t2f1">Frequencies of adverse reactions are based on all adverse events attributed to trial drugs by the investigator.</footnote> (All Grades) Reported in ≥ 2% of Adults with HIV-1 Receiving BIXLENVO in Trials ARTISTRY-1 or ARTISTRY-2 (Week 48 Analysis). </caption><col width="20%" align="left" valign="middle"/><col width="20%" align="center" valign="middle"/><col width="20%" align="center" valign="middle"/><col width="20%" align="center" valign="middle"/><col width="20%" align="center" valign="middle"/><thead><tr styleCode="Botrule"><th styleCode="Lrule Rrule"/><th styleCode="Rrule" colspan="2">ARTISTRY-1<footnote ID="t2f2">ARTISTRY-1 was open-label with a stable baseline regimen as the comparator. </footnote></th><th styleCode="Rrule" colspan="2">ARTISTRY-2 <footnote ID="t2f3">ARTISTRY-2 was blinded with BIKTARVY as the comparator.</footnote></th></tr><tr styleCode="Botrule"><th styleCode="Lrule Rrule">Adverse Reactions</th><th styleCode="Rrule">BIXLENVO N=371</th><th styleCode="Rrule">Stable Baseline Regimen N=186</th><th styleCode="Rrule">BIXLENVO N=383</th><th styleCode="Rrule">BIKTARVY N=191</th></tr></thead><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Headache</td><td styleCode="Rrule">4%</td><td styleCode="Rrule">0</td><td styleCode="Rrule">1%</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Nausea</td><td styleCode="Rrule">3%</td><td styleCode="Rrule">0</td><td styleCode="Rrule">3%</td><td styleCode="Rrule">4%</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Diarrhea</td><td styleCode="Rrule">2%</td><td styleCode="Rrule">0</td><td styleCode="Rrule">2%</td><td styleCode="Rrule">2%</td></tr></tbody></table>