Respuestas rápidas
- ¿Para qué se usa Doravirine, islatravir?
- La etiqueta aprobada por la FDA (Idvynso, Merck Sharp & Dohme LLC, 20 de abril de 2026) dice, en inglés: “IDVYNSO™ is indicated as a complete two-drug 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/mL) on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine […]. …” 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 Doravirine, islatravir?
- La sección «Adverse Reactions» (reacciones adversas) de la etiqueta de la FDA (Idvynso, Merck Sharp & Dohme LLC, 20 de abril de 2026) comienza así, en inglés: «The following serious adverse reactions are described in greater detail in other sections of the labeling: Skin and Hypersensitivity Reactions [see Warnings and Precautions (5.1)] Most common adverse reactions (incidence greater than or equal to 2%, all grades): diarrhea, dizziness, fatigue, abdominal distension, headache, and weight increased.» … Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.
- ¿Qué interacciones tiene Doravirine, islatravir?
- La sección «Drug Interactions» (interacciones) de la etiqueta de la FDA (Idvynso, Merck Sharp & Dohme LLC, 20 de abril de 2026) comienza así, en inglés: «Because IDVYNSO is a complete regimen, co-administration with other antiretroviral medications for treatment of HIV-1 infection is not recommended. (7.1) Consult the full prescribing information prior to and during treatment for important potential drug-drug interactions.» … Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.
- ¿Doravirine, islatravir 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 Doravirine, islatravir?
- 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 Doravirine, islatravir?
- No aparece ningún retiro vinculado a los productos de este medicamento en los informes de la FDA que usamos.
- ¿Quién fabrica Doravirine, islatravir?
- 1 empresa tiene productos con receta de Doravirine, islatravir en el directorio NDC de la FDA, entre ellas Merck Sharp & Dohme LLC.
Para qué se usa Doravirine, islatravir
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.
IDVYNSO™ is indicated as a complete two-drug 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/mL) on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine […]. …
— Etiqueta de la FDA: Idvynso, Merck Sharp & Dohme LLC, vigente desde el 20 de abril de 2026. Leer la etiqueta completa en DailyMed →
Etiqueta citada: la de la presentación más común (tablet, film coated, oral), Idvynso, Merck Sharp & Dohme LLC; 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 Doravirine, islatravir
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.
The following serious adverse reactions are described in greater detail in other sections of the labeling: Skin and Hypersensitivity Reactions [see Warnings and Precautions (5.1)] Most common adverse reactions (incidence greater than or equal to 2%, all grades): diarrhea, dizziness, fatigue, abdominal distension, headache, and weight increased.
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(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 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. Adverse Reactions in Virologically-Suppressed Adults Living with HIV-1 Who Switched to IDVYNSO The safety assessment of IDVYNSO in virologically-suppressed (HIV-1 RNA less than 50 copies/mL) participants living with HIV was based on Week 48 data from two Phase 3, randomized trials, Trial 051 and Trial 052. A total of 708 participants received once-daily IDVYNSO [see Clinical Studies (14)]. In Trial 051, an open-label trial with 551 participants, 366 participants were switched to IDVYNSO and 185 participants continued their baseline antiretroviral therapy (ART). By Week 48, 0.5% in the IDVYNSO group and 2% in the baseline ART group had adverse events leading to discontinuation of study medication. In Trial 052, a double-blinded trial with 513 participants, 342 participants were switched to IDVYNSO and 171 participants continued on bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). By Week 48, 3% in the IDVYNSO group and 2% in the BIC/FTC/TAF group had adverse events leading to discontinuation of study medication. Among participants who received IDVYNSO and experienced at least one adverse event in Trial 051 or Trial 052, 88% experienced only adverse events that were mild (Grade 1) or moderate (Grade 2). The most common adverse reactions (all grades) reported in greater than or equal to 2% of participants in any treatment group from Trial 051 and Trial 052 through Week 48 are presented in Table 1.
Tabla de la etiqueta
| Adverse Reactions | Trial 051 | Trial 052 | ||
|---|---|---|---|---|
| IDVYNSO N=366 | Baseline ART N=185 | IDVYNSO N=342 | BIC/FTC/TAF N=171 | |
| Diarrhea | 3% | 0 | 1% | 1% |
| Dizziness | 2% | 1% | 1% | 0 |
| FatigueFatigue includes fatigue and asthenia. | 2% | 1% | 1% | 1% |
| Abdominal distension | 2% | 0 | 1% | 0 |
| Headache | 2% | 1% | 1% | 0 |
| Weight increasedThe mean change in weight from baseline at Week 48 was 0.94 kg in the IDVYNSO group vs. -0.15 kg in the baseline ART group in Trial 051, and -0.03 kg in the IDVYNSO group vs. 0.28 kg in the BIC/FTC/TAF group in Trial 052. | 2%4 of the 6 participants with adverse reactions of weight increased switched from a baseline ART regimen containing efavirenz and/or tenofovir disoproxil fumarate in Trial 051. | 0 | <1% | 0 |
— Etiqueta de la FDA: Idvynso, Merck Sharp & Dohme LLC, vigente desde el 20 de abril de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Interacciones de Doravirine, islatravir
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 IDVYNSO is a complete regimen, co-administration with other antiretroviral medications for treatment of HIV-1 infection is not recommended. (7.1) Consult the full prescribing information prior to and during treatment for important potential drug-drug interactions.
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(2.2, 4, 5.2, 7, 12.3) 7.1 Concomitant Use with Other Antiretroviral Medications Because IDVYNSO is a complete regimen for the treatment of HIV-1 infection, co-administration with other antiretroviral medications for treatment of HIV-1 infection is not recommended. 7.2 Effects of Other Drugs on IDVYNSO Doravirine Co-administration of IDVYNSO with a CYP3A inducer decreases doravirine plasma concentrations, which may reduce the efficacy of IDVYNSO [see Contraindications (4), Warnings and Precautions (5.2), and Clinical Pharmacology (12.3)]. Co-administration of IDVYNSO and drugs that are inhibitors of CYP3A may result in increased plasma concentrations of doravirine. Islatravir Islatravir requires phosphorylation by cellular kinases to form the pharmacologically active ISL-TP. Co-administration of IDVYNSO and drugs that are substrates of dCK (e.g., certain nucleoside antiviral agents and nucleoside antimetabolites) may result in a decrease in ISL-TP concentrations and may reduce the therapeutic effect of islatravir [see Contraindications (4), Warnings and Precautions (5.2), and Clinical Pharmacology (12.3)]. Islatravir is subject to ADA-mediated metabolism (approximately 53%). Co-administration of IDVYNSO and drugs that are ADA inhibitors (e.g., pentostatin) may result in increased plasma concentrations of islatravir and may increase the risk of adverse reactions [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)]. The drug interactions described in Table 3 are based on studies conducted with IDVYNSO, its components, or are predicted drug interactions that may occur with IDVYNSO. Table 3: Drug Interactions with IDVYNSO This table is not all inclusive. Concomitant Drug Class: Drug Name Effect on Concentration Clinical Comment ↑ = increase, ↓ = decrease Strong CYP3A Inducers ↓ doravirine Co-administration with strong CYP3A inducers is contraindicated At least a 4-week cessation period is recommended prior to initiation of IDVYNSO. Moderate CYP3A Inducers ↓ doravirine If IDVYNSO is co-administered with rifabutin Interactions were evaluated in clinical studies. All other drug-drug interactions are predicted., one tablet of doravirine (PIFELTRO) should be taken approximately 12 hours after the dose of IDVYNSO [see Dosage and Administration (2.2)]. Co-administration with other moderate CYP3A inducers is not recommended. dCK Substrates May include other nucleoside drugs Anti-virals lamivudine emtricitabine ↓ ISL-TP Co-administration is contraindicated with lamivudine or emtricitabine. Nucleoside Antimetabolites cladribine clofarabine cytarabine fludarabine gemcitabine ↓ ISL-TP Co-administration with these nucleoside antimetabolites is not recommended as dCK substrates may cause a decrease in the intracellular concentration of ISL-TP.
— Etiqueta de la FDA: Idvynso, Merck Sharp & Dohme LLC, vigente desde el 20 de abril de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Dosis de Doravirine, islatravir
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: One tablet taken orally once daily with or without food in adults. (2.1) Dosage adjustment with rifabutin: Take one tablet of IDVYNSO once daily, followed by one tablet of doravirine (PIFELTRO) 100 mg approximately 12 hours after the dose of IDVYNSO. (2.2) 2.1 Recommended Dosage The recommended dosage of IDVYNSO is one tablet taken orally once daily with or without food [see Clinical Pharmacology (12.3)].
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One tablet of IDVYNSO contains 100 mg doravirine and 0.25 mg islatravir. 2.2 Dosage Adjustment with Rifabutin If IDVYNSO is co-administered with rifabutin, take one tablet of IDVYNSO once daily as recommended, followed by one tablet of doravirine (PIFELTRO) 100 mg approximately 12 hours after the dose of IDVYNSO for the duration of rifabutin co-administration [see Drug Interactions (7.2) and Clinical Pharmacology (12.3)].
— Etiqueta de la FDA: Idvynso, Merck Sharp & Dohme LLC, vigente desde el 20 de abril de 2026. Leer la etiqueta completa en DailyMed →
Doravirine, islatravir 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 IDVYNSO during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary There are insufficient human data on the use of IDVYNSO during pregnancy to inform a drug-associated risk of birth defects and miscarriage.
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In animal reproduction studies, no developmental effects were observed when the components of IDVYNSO were administered separately at exposures (AUC) at least 8 (doravirine) and 500 (islatravir) times the exposure at the recommended human dose (RHD) of these components in IDVYNSO (see Data.) The background rate of major birth defects is 2.7% in a U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP). 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%. Methodological limitations of the APR include the use of MACDP as the external comparator group. The MACDP population is not disease-specific, evaluates individuals and infants from the limited geographic area, and does not include outcomes for births that occurred at less than 20 weeks gestation. Data Animal Data Doravirine Doravirine was administered orally to pregnant rabbits (up to 300 mg/kg/day on Gestation Days (GD) 7 to 20) and rats (up to 450 mg/kg/day on GD 6 to 20 and separately from GD 6 to Lactation/Postpartum Day 20). No significant toxicological effects on embryo-fetal (rats and rabbits) or pre/post-natal (rats) development were observed at exposures (AUC) approximately 9 times (rats) and 8 times (rabbits) the exposure in humans at the RHD. Doravirine was transferred to the fetus through the placenta in embryo-fetal studies, with fetal plasma concentrations of up to 40% (rabbits) and 52% (rats) that of maternal concentrations observed on GD 20. Islatravir Islatravir was administered orally to pregnant rabbits (up to 10 mg/kg/day on GD 7 to 20) and rats (up to 50 mg/kg/day on GD 6 to 20 and separately up to 10 mg/kg from GD 6 to Lactation/Postpartum Day 20). No significant toxicological effects on embryo-fetal (rats and rabbits) or pre/post-natal (rats) development were observed at exposures (AUC) approximately 500 times (rats) and 1300 times (rabbits) the exposure in humans at the RHD. In rats, islatravir was transferred to the fetus through the placenta in rats, with fetal plasma concentrations of up to 88% that of maternal concentrations observed on GD 20.
— Etiqueta de la FDA: Idvynso, Merck Sharp & Dohme LLC, vigente desde el 20 de abril de 2026. Leer la etiqueta completa en DailyMed →
Cuándo no se debe usar Doravirine, islatravir
Cita de la sección «Contraindications» (contraindicaciones) de la etiqueta aprobada por la FDA. Se muestra en inglés.
IDVYNSO is contraindicated when co-administered with: drugs that are strong cytochrome P450 (CYP)3A enzyme inducers as significant decreases in doravirine plasma concentrations may occur, which may decrease the effectiveness of IDVYNSO [see Warnings and Precautions (5.2), Drug Interactions (7.2), and Clinical Pharmacology (12.3)]. lamivudine (3TC) or emtricitabine (FTC) as significant decreases in islatravir-triphosphate (ISL-TP) concentrations may occur, which may decrease the effectiveness of IDVYNSO [see Warnings and Precautions (5.2), Drug Interactions (7.2) and Clinical Pharmacology (12.3)].
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IDVYNSO is contraindicated when co-administered with drugs that are strong cytochrome P450 (CYP)3A enzyme inducers as significant decreases in doravirine plasma concentrations may occur, which may decrease the effectiveness of IDVYNSO. (4) IDVYNSO is contraindicated when co-administered with lamivudine (3TC) or emtricitabine (FTC), which are deoxycytidine kinase (dCK) substrates, as a decrease in islatravir-triphosphate (ISL-TP) levels may occur, which may decrease the effectiveness of IDVYNSO. (4)
— Etiqueta de la FDA: Idvynso, Merck Sharp & Dohme LLC, vigente desde el 20 de abril de 2026. Leer la etiqueta completa en DailyMed →
Sobredosis de Doravirine, islatravir
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 IDVYNSO and there is no known specific treatment for overdose with IDVYNSO. If overdose occurs, the person should be monitored, and standard supportive treatment applied as required.
— Etiqueta de la FDA: Idvynso, Merck Sharp & Dohme LLC, vigente desde el 20 de abril 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 | Idvynso |
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.
- Merck Sharp & Dohme LLC1 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 |
|---|---|---|---|
| NDA216964 IDVYNSO | Msd | 20 de abril 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) | 2741694, 2741700 |
|---|---|
| ID (SPL set ID) de la etiqueta citada | 11aaeb53-9848-433c-be7f-db8a5bc0b26f |
| Etiquetas de la FDA (SPL) | 1 |
| Solicitudes de la FDA | NDA216964 |
| Principios activos (FDA) | DORAVIRINE / ISLATRAVIR |
Siguientes pasos
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- Últimos retiros de medicamentos de la FDATodos los medicamentos, los más recientes primero
- Merck Sharp & Dohme LLCFabricante 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) — Idvynso, Merck Sharp & Dohme LLC, vigente desde el 20 de abril 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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