Respuestas rápidas
- ¿Para qué se usa Bictegravir/lenacapavir?
- La etiqueta aprobada por la FDA (Bixlenvo, Gilead Sciences, Inc., 27 de agosto de 2026) dice, en inglés: “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 […]. …” Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.
- ¿Cuáles son los efectos secundarios de Bictegravir/lenacapavir?
- La sección «Adverse Reactions» (reacciones adversas) de la etiqueta de la FDA (Bixlenvo, Gilead Sciences, Inc., 27 de agosto de 2026) comienza así, en inglés: «Most common adverse reactions (incidence greater than or equal to 2%, all grades) are headache, nausea, and diarrhea.» … Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.
- ¿Qué interacciones tiene Bictegravir/lenacapavir?
- La sección «Drug Interactions» (interacciones) de la etiqueta de la FDA (Bixlenvo, Gilead Sciences, Inc., 27 de agosto de 2026) comienza así, en inglés: «Because BIXLENVO is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended (7.1) Consult the Full Prescribing Information prior to and during treatment for important drug interactions.» … Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.
- ¿Bictegravir/lenacapavir tiene una advertencia en recuadro?
- No. Ninguna de las 1 etiquetas de la FDA que encontramos para este medicamento tiene advertencia en recuadro.
- ¿Hay escasez de Bictegravir/lenacapavir?
- La FDA no indica una escasez actual para los productos de este medicamento (datos de la FDA del 30 de octubre de 2026).
- ¿Se ha retirado del mercado Bictegravir/lenacapavir?
- No aparece ningún retiro vinculado a los productos de este medicamento en los informes de la FDA que usamos.
- ¿Quién fabrica Bictegravir/lenacapavir?
- 1 empresa tiene productos con receta de Bictegravir/lenacapavir en el directorio NDC de la FDA, entre ellas Gilead Sciences, Inc.
Para qué se usa Bictegravir/lenacapavir
Cita de la sección «Indications and Usage» (indicaciones y uso) de la etiqueta aprobada por la FDA. Se muestra en inglés, tal como la publica la FDA.
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 […]. …
— Etiqueta de la FDA: Bixlenvo, Gilead Sciences, Inc., vigente desde el 27 de agosto de 2026. Leer la etiqueta completa en DailyMed →
Etiqueta citada: la de la presentación más común (tablet, film coated, oral), Bixlenvo, Gilead Sciences, Inc.; abarca 1 producto del directorio NDC de la FDA. Las citas sobre efectos secundarios, interacciones, dosis y embarazo de abajo vienen de esta misma etiqueta.
Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.
Advertencia en recuadro
La advertencia en recuadro («caja negra») es la advertencia más seria de la FDA en la etiqueta de un medicamento, para riesgos graves o mortales.
La etiqueta citada arriba no tiene advertencia en recuadro.
Efectos secundarios de Bictegravir/lenacapavir
Cita de la sección «Adverse Reactions» (reacciones adversas) de la etiqueta aprobada por la FDA. Se muestra en inglés. Avise a su médico de cualquier efecto secundario que le preocupe.
Most common adverse reactions (incidence greater than or equal to 2%, all grades) are headache, nausea, and diarrhea.
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(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.
Tabla de la etiqueta
| ARTISTRY-1ARTISTRY-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% |
— Etiqueta de la FDA: Bixlenvo, Gilead Sciences, Inc., vigente desde el 27 de agosto de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Interacciones de Bictegravir/lenacapavir
Cita de la sección «Drug Interactions» (interacciones) de la etiqueta aprobada por la FDA. Se muestra en inglés. Dígale a su farmacéutico todos los medicamentos, vitaminas y productos herbales que toma.
Because BIXLENVO is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended (7.1) Consult the Full Prescribing Information prior to and during treatment for important drug interactions.
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(4, 5.1, 7, 12.3) 7.1 Other Antiretroviral Medications Because BIXLENVO is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended [see Indications and Usage (1)]. 7.2 Potential for BIXLENVO to Affect Other Drugs Bictegravir (BIC), a component of BIXLENVO, inhibits organic cation transporter 2 (OCT2) and multidrug and toxin extrusion transporter 1 (MATE1) in vitro. Coadministration of BIC with drugs that are substrates of OCT2 and MATE1 (e.g., dofetilide) may increase their plasma concentrations (see Table 4). Lenacapavir (LEN), a component of BIXLENVO, is a moderate inhibitor of CYP3A and a P-gp inhibitor. Coadministration of LEN with sensitive substrates of CYP3A or P-gp may increase the concentrations of these substrates and result in the increased risk of their adverse events. See the prescribing information of these sensitive substrates for dosing recommendations or appropriate monitoring of safety. 7.3 Potential for Other Drugs to Affect the Components of BIXLENVO BIC is a substrate of CYP3A and UGT1A1. LEN is a substrate of P-gp, UGT1A1, and CYP3A. Strong or Moderate CYP3A Inducers A drug that is a strong inducer of CYP3A and also an inducer of UGT1A1 can substantially decrease the plasma concentrations of BIC. Drugs that are strong or moderate inducers of CYP3A may significantly decrease plasma concentrations of LEN [see Clinical Pharmacology (12.3)]. Strong or moderate CYP3A inducers may result in loss of therapeutic effect of BIXLENVO and development of resistance. Concomitant administration of BIXLENVO with strong CYP3A inducers is contraindicated [see Contraindications (4)]. Concomitant administration of BIXLENVO with moderate CYP3A inducers is not recommended. Combined P-gp, UGT1A1, and Strong CYP3A Inhibitors Combined UGT1A1 and strong CYP3A inhibitors may significantly increase plasma concentrations of BIC. Combined P-gp, UGT1A1, and strong CYP3A inhibitors may significantly increase plasma concentrations of LEN. Concomitant administration of BIXLENVO with combined P-gp, UGT1A1, and strong CYP3A inhibitors is not recommended. 7.4 Established and Other Potentially Significant Drug Interactions Table 4 provides a listing of established or potentially clinically significant drug interactions with recommended prevention or management strategies, but is not all inclusive. The drug interactions described are based on studies conducted with the components of BIXLENVO (BIC or LEN) as individual agents, or are drug interactions that may occur with BIXLENVO [see Contraindications (4), Warnings and Precautions (5.1), and Clinical Pharmacology (12.3)].
— Etiqueta de la FDA: Bixlenvo, Gilead Sciences, Inc., vigente desde el 27 de agosto de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Dosis de Bictegravir/lenacapavir
Cita de la sección «Dosage and Administration» (dosis y administración) de la etiqueta aprobada por la FDA. Se muestra en inglés. Su dosis es la que le receta su médico: no la cambie por su cuenta.
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.
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(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)].
Tabla de la etiqueta
| 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 |
— Etiqueta de la FDA: Bixlenvo, Gilead Sciences, Inc., vigente desde el 27 de agosto de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Bictegravir/lenacapavir en el embarazo
Cita de la parte sobre embarazo (Pregnancy) de la etiqueta aprobada por la FDA. Se muestra en inglés. Pregunte a su médico antes de tomar cualquier medicamento si está embarazada o planea estarlo.
Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to BIXLENVO during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263.
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Risk Summary Available data from observational studies and the APR with BIC use during pregnancy have not established a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Available data from the APR show no statistically significant difference in the overall risk of major birth defects for BIC compared with the background rate for major birth defects of 2.7% in a U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP) (see Data). The rate of miscarriage is not reported in the APR. The estimated background rate of miscarriage in the clinically recognized pregnancies in the U.S. general population is 15-20%. BIC safety has also been evaluated in an open-label trial in individuals with HIV-1 that demonstrated safety findings that were consistent with other trials in adults (see Data). Available data from a randomized, controlled trial with LEN use during pregnancy in individuals without HIV-1 have not identified a drug-associated risk for miscarriage, or adverse maternal or fetal outcomes when compared to an active control (see Data). The rate of major birth defects in LEN-exposed pregnancies did not exceed the background prevalence rates. The risk estimates are imprecise due to small numbers of exposed pregnancies (see Data). In animal reproduction studies, no evidence of adverse developmental outcomes was observed with BIC at exposures that were either not maternally toxic (rabbits) or greater than (rats and mice) those in humans at the recommended human dose (RHD) (see Data). During organogenesis, systemic exposures (AUC) to BIC were approximately 24 (rats) and 0.39 times (rabbits) the exposure at the RHD of BIXLENVO. In rat pre/postnatal development studies, maternal systemic exposures (AUC) were 20 times (BIC) the exposure in humans at the RHD. In animal reproduction studies, no adverse developmental effects were observed when LEN was administered to rats and rabbits at exposures (AUC) ≥3 times the exposure in humans at the RHD of BIXLENVO (see Data). Data Human Data Bictegravir A BIC-containing regimen was evaluated in an open-label clinical trial of 33 virologically suppressed (HIV-1 RNA < 50 copies/mL) pregnant adults with HIV-1 and no known substitutions associated with resistance to BIC. Pregnant adults were administered a BIC-containing regimen once daily from the second or third trimester through postpartum. Exposures of BIC were lower during pregnancy as compared to postpartum. All 32 adult participants who completed the study maintained viral suppression during pregnancy, at delivery, and through Week 18 postpartum.
— Etiqueta de la FDA: Bixlenvo, Gilead Sciences, Inc., vigente desde el 27 de agosto de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Cuándo no se debe usar Bictegravir/lenacapavir
Cita de la sección «Contraindications» (contraindicaciones) de la etiqueta aprobada por la FDA. Se muestra en inglés.
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)
— Etiqueta de la FDA: Bixlenvo, Gilead Sciences, Inc., vigente desde el 27 de agosto de 2026. Leer la etiqueta completa en DailyMed →
Sobredosis de Bictegravir/lenacapavir
Cita de la sección «Overdosage» (sobredosis) de la etiqueta aprobada por la FDA. Se muestra en inglés. Si alguien pudo haber tomado demasiado, llame a Poison Help al 1-800-222-1222 (o al 911 en una emergencia).
No data are available on overdose of BIXLENVO in patients. If overdose occurs, monitor the patient for evidence of toxicity. Treatment of overdose with BIXLENVO consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient. As BIC and LEN are highly bound to plasma proteins, they are unlikely to be significantly removed by dialysis.
— Etiqueta de la FDA: Bixlenvo, Gilead Sciences, Inc., vigente desde el 27 de agosto de 2026. Leer la etiqueta completa en DailyMed →
Presentaciones y vía de administración
| Formas farmacéuticas | Tableta, recubierta con película |
|---|---|
| Vía | Oral |
| Productos con receta | 1 en el directorio NDC de la FDA |
| Nombres de marca | Bixlenvo |
Empresas que tienen este medicamento
Empresas en el directorio NDC de la FDA: la empresa que aparece en el envase (fabricante o distribuidor), con su número de productos con receta.
- Gilead Sciences, Inc.1 producto
Historial de aprobación de la FDA
- NDA: Solicitud de nuevo medicamento (NDA): así se aprueba un medicamento nuevo, normalmente de marca.
| Solicitud | Patrocinador | Aprobada | Cambios aprobados después |
|---|---|---|---|
| NDA221104 BIXLENVO | Gilead Sciences Inc | 27 de agosto de 2026 | — |
Escasez
La lista de escasez de la FDA no incluye estos productos.
Retiros del mercado
No aparece ningún retiro vinculado a estos productos (por su código NDC) en los informes de la FDA.
Identificadores oficiales
| RxCUI (RxNorm) | 2750177, 2750183 |
|---|---|
| ID (SPL set ID) de la etiqueta citada | 072a3c7e-33fb-4a87-ba21-3d8dad3f5c48 |
| Etiquetas de la FDA (SPL) | 1 |
| Solicitudes de la FDA | NDA221104 |
| Principios activos (FDA) | BICTEGRAVIR / LENACAPAVIR |
Siguientes pasos
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- Últimos retiros de medicamentos de la FDATodos los medicamentos, los más recientes primero
- Gilead Sciences, Inc.Fabricante o distribuidor
- Todos los medicamentos con receta de la A a la ZBusque por nombre genérico, de marca o en español
Fuentes
- Etiqueta aprobada por la FDA en DailyMed (Biblioteca Nacional de Medicina) — Bixlenvo, Gilead Sciences, Inc., vigente desde el 27 de agosto de 2026; vía openFDA, datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
- NDC Directory (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
- Drugs@FDA (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
- Drug recall enforcement reports (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 27 de octubre de 2026, consultados el 31 de octubre de 2026
- Drug shortages (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
La FDA ofrece los datos de openFDA tal cual; pueden estar incompletos. Guíese siempre por la etiqueta que viene con su medicamento. Buscador de informes de retiros de la FDA →
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