Ropeginterferon ALFA-2B

Para qué se usa Ropeginterferon ALFA-2B

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.

BESREMi is an interferon alfa-2b indicated for: • The treatment of adults with essential thrombocythemia. • The treatment of adults with polycythemia vera. 1.1 Essential Thrombocythemia BESREMi is indicated for the treatment of adults with essential thrombocythemia. 1.2 Polycythemia Vera BESREMi is indicated for the treatment of adults with polycythemia vera.

— Etiqueta de la FDA: BESREMi, PharmaEssentia USA, vigente desde el 25 de agosto de 2026. Leer la etiqueta completa en DailyMed →

Etiqueta citada: la de la presentación más común (injection, subcutaneous), BESREMi, PharmaEssentia USA; abarca 2 productos del directorio NDC de la FDA. Las citas sobre efectos secundarios, interacciones, dosis y embarazo de abajo vienen de esta misma etiqueta.

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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.

Esta etiqueta tiene una advertencia en recuadro. Su título: WARNING: RISK OF SERIOUS DISORDERS. Leerla en la etiqueta completa →

Ropeginterferon ALFA-2B: lo que dice la advertencia en recuadro

Cita de la advertencia en recuadro (Boxed Warning) de la etiqueta aprobada por la FDA. Se muestra en inglés.

WARNING: RISK OF SERIOUS DISORDERS Risk of Serious Disorders: Interferon alfa products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions.

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In many, but not all cases, these disorders resolve after stopping therapy [see Warnings and Precautions (5.1, 5,2, 5.3, 5.4) and Adverse Reactions (6.1)]. WARNING: RISK OF SERIOUS DISORDERS See full prescribing information for complete boxed warning. Risk of Serious Disorders: Interferon alfa products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Monitor closely and withdraw therapy with persistently severe or worsening signs or symptoms of the above disorders. (5.1, 5.2, 5.3, 5.4)

— Etiqueta de la FDA: BESREMi, PharmaEssentia USA, vigente desde el 25 de agosto de 2026. Leer la etiqueta completa en DailyMed →

Efectos secundarios de Ropeginterferon ALFA-2B

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 clinically significant adverse reactions are described elsewhere in the labeling.

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• Depression and Suicide [see Warnings and Precautions (5.1)]
• Endocrine Toxicity [see Warnings and Precautions (5.2)]
• Cardiovascular Toxicity [see Warnings and Precautions (5.3)]
• Hematologic and Hemorrhagic Disorders [see Warnings and Precautions (5.4)]
• Hypersensitivity Reactions [see Warnings and Precautions (5.5)]
• Pancreatitis [see Warnings and Precautions (5.6)]
• Colitis [see Warnings and Precautions (5.7)]
• Pulmonary Toxicity [see Warnings and Precautions (5.8)]
• Ophthalmologic Toxicity [see Warnings and Precautions (5.9)]
• Hyperlipidemia [see Warnings and Precautions (5.10)]
• Hepatotoxicity [see Warnings and Precautions (5.11)]
• Renal Toxicity [see Warnings and Precautions (5.12)]
• Dental and Periodontal Toxicity [see Warnings and Precautions (5.13)]
• Dermatologic Toxicity [see Warnings and Precautions (5.14)]
• Driving and Operating Machinery [see Warnings and Precautions (5.15)]
• Embryo-Fetal Toxicity [see Warnings and Precautions (5.16)]
• Essential thrombocythemia: The most common adverse reactions reported in >20% of patients were transaminase elevations, anemia, pyrexia, beta 2 microglobulin urine increased, bacterial infection, pruritus, and weight decreased. (6)
• Polycythemia vera: The most common adverse reactions reported in >40% of patients were influenza-like illness, arthralgia, fatigue, pruritus, nasopharyngitis, and musculoskeletal pain. (6) To report SUSPECTED ADVERSE REACTIONS, contact PharmaEssentia at 1-800-999-2449 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. Essential Thrombocythemia The pooled safety population described in the Warnings and Precautions section reflects exposure to BESREMi as monotherapy for the treatment of essential thrombocythemia dosed every 2 weeks in 182 patients in an open-label trial [P1101 ET, SURPASS ET] and a single-arm trial [A22-301, EXCEED ET]. The mean age was 56 years (range: 21 to 84 years). There were 104 (57%) women, 78 (43%) men, and 93 (51%) Asian, 76 (42%) Caucasian, 5 (2.7%) Black or African American, 5 (2.7%) Other, and 3 (1.6%) Hispanic patients were included in the studies. Among 182 patients who received BESREMi, 70 (39%) patients were exposed for >56 weeks (>14 months). The mean (SD) dose of BESREMi was 394.9 (98.4) mcg during the treatment period.

— Etiqueta de la FDA: BESREMi, PharmaEssentia USA, vigente desde el 25 de agosto de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Interacciones de Ropeginterferon ALFA-2B

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.

• Monitor patients taking CYP450 substrates with a narrow therapeutic index for adverse reactions to inform the need for dose adjustment of the concomitant drug (7.1)
• Avoid use with myelosuppressive agents and monitor patients receiving the combination for effects of excessive myelosuppression (7.2)
• Avoid use with narcotics, hypnotics or sedatives.

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Monitor patients receiving the combination for excessive central nervous system toxicity (7.3) 7.1 Drugs Metabolized by Cytochrome P450 Certain proinflammatory cytokines, including interferons, can suppress CYP450 enzymes resulting in increased exposures of some CYP substrates [see Clinical Pharmacology (12.3)]. Therefore, patients on BESREMi who are receiving concomitant drugs that are CYP450 substrates with a narrow therapeutic index should be monitored to inform the need for dosage modification for these concomitant drugs. 7.2 Myelosuppressive Agents Concomitant use of BESREMi and myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression [see Warnings and Precautions (5.4)]. 7.3 Narcotics, Hypnotics or Sedatives Concomitant use of BESREMi and narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity [see Warnings and Precautions (5.1)].

— Etiqueta de la FDA: BESREMi, PharmaEssentia USA, vigente desde el 25 de agosto de 2026. Leer la etiqueta completa en DailyMed →

Dosis de Ropeginterferon ALFA-2B

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.

Essential thrombocythemia:

• The recommended dose of BESREMi is: a starting dose of 250 mcg by subcutaneous injection, at 2 weeks, increase the dose to 350 mcg by subcutaneous injection, at 4 weeks, increase to the maintenance dosage of 500 mcg by subcutaneous injection every 2 weeks. Maintain an every 2‑week schedule throughout treatment unless dose modification is required for safety or tolerability.

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Consider dose re-escalation in case of prior dose reduction, recovery, and lack of hematologic response. (2.2, 2.3, 5) Polycythemia vera:

• The recommended dose of BESREMi is: a starting dosage of 100 mcg by subcutaneous injection every 2 weeks (50 mcg if receiving hydroxyurea). Increase the dose by 50 mcg every 2 weeks (up to a maximum of 500 mcg) until hematological parameters are stabilized (2.1). Interrupt or discontinue dosing if certain adverse reactions occur. Dose re-increase to be considered in case of prior dose reduction, recovery, and lack of hematologic response. (2.2, 2.3, 5) 2.1 Pre-Treatment Testing Obtain a pregnancy test in females of reproductive potential prior to initiating treatment with BESREMi [see Use in Specific Populations (8.3)]. 2.2 Recommended Dosage Essential Thrombocythemia:
• The recommended dose of BESREMi is:
• A starting dose of 250 mcg by subcutaneous injection.
• At 2 weeks, increase the dose to 350 mcg by subcutaneous injection.
• At 4 weeks, increase to the maintenance dosage of 500 mcg by subcutaneous injection every 2 weeks.
• Maintain an every 2-week schedule throughout treatment unless dose modification is required for safety or tolerability.
• Consider dose re-escalation in case of prior dose reduction, recovery, and lack of hematologic response (platelets less than 400 × 10 9 /L and leukocytes less than 10 × 10 9 /L).
• Monitor complete blood counts every 2 weeks during titration and every 3 to 6 months during maintenance. Polycythemia Vera: Patients Not Already on Hydroxyurea
• The recommended BESREMi starting dosage for patients not on hydroxyurea is 100 mcg by subcutaneous injection every two weeks.
• Increase the dose by 50 mcg every two weeks (up to a maximum of 500 mcg), until the hematological parameters are stabilized (hematologic response: hematocrit less than 45%, platelets less than 400 × 10 9 /L, and leukocytes less than 10 × 10 9 /L).
• Consider dose re-escalation in case of prior dose reduction, recovery, and lack of hematologic response. Patients Transitioning from Hydroxyurea
• When transitioning to BESREMi from hydroxyurea, start BESREMi at 50 mcg by subcutaneous injection every two weeks in combination with hydroxyurea.
• Gradually taper off the hydroxyurea by reducing the total biweekly dose by 20-40% every two weeks during Weeks 3-12.
• Increase the dose of BESREMi by 50 mcg every two weeks (up to a maximum of 500 mcg), until the hematological parameters are stabilized (hematocrit less than 45%, platelets less than 400 × 10 9 /L, and leukocytes less than 10 × 10 9 /L).
• Discontinue hydroxyurea by Week 13. Maintain the two-week dosing interval of BESREMi at which hematological stability is achieved for at least 1 year.

— Etiqueta de la FDA: BESREMi, PharmaEssentia USA, vigente desde el 25 de agosto de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Ropeginterferon ALFA-2B 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.

Risk Summary Available human data with BESREMi use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. An abortifacient effect was reported in cynomolgus monkeys receiving ropeginterferon alfa-2b (see Data).

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Based on mechanism of action and the role of interferon alfa in pregnancy and fetal development, BESREMi can cause fetal harm and should be assumed to have abortifacient potential when administered to a pregnant woman. There are adverse effects on maternal and fetal outcomes associated with polycythemia vera in pregnancy (see Clinical Considerations). Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage is 2-4% and 15-20%, respectively. Data Animal Data In an embryo-fetal development study, pregnant cynomolgus monkeys received subcutaneous injection of ropeginterferon alfa-2b twice weekly during the period of organogenesis (Gestation Days 20-48). Maternal toxicity, characterized by a significant decline in food consumption and transient body weight loss, occurred at all dose levels and ropeginterferon alfa-2b was abortifacient and caused embryonic death at exposures 275-times (C max) and 64-times (AUC) the human exposure at the maximum recommended human dose of 500 mcg. There were no effects on fetal developmental parameters or abnormalities in the surviving fetuses (GD 100) where the ropeginterferon alfa-2b exposures achieved in pregnant cynomolgus monkeys during the first trimester were 961-times (C max) and 224-times (AUC) the human exposure at the maximum recommended human dose of 500 mcg. Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Untreated polycythemia vera during pregnancy is associated with adverse maternal outcomes such as thrombosis and hemorrhage. Adverse pregnancy outcomes associated with polycythemia vera include increased risk for miscarriage.

— Etiqueta de la FDA: BESREMi, PharmaEssentia USA, vigente desde el 25 de agosto de 2026. Leer la etiqueta completa en DailyMed →

Cuándo no se debe usar Ropeginterferon ALFA-2B

Cita de la sección «Contraindications» (contraindicaciones) de la etiqueta aprobada por la FDA. Se muestra en inglés.

BESREMi is contraindicated in patients with:

• Existence of, or history of severe psychiatric disorders, particularly severe depression, suicidal ideation, or suicide attempt.
• Hypersensitivity to interferons including interferon alfa-2b or any of the inactive ingredients of BESREMi.
• Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment.
• History or presence of active serious or untreated autoimmune disease.
• Immunosuppressed transplant recipients.

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BESREMi is contraindicated in patients with:

• Existence of, or history of severe psychiatric disorders, particularly severe depression, suicidal ideation or suicide attempt (4)
• Hypersensitivity to interferons or to any of the inactive ingredients in BESREMi (4)
• Hepatic impairment (Child-Pugh B or C) (4)
• History or presence of active serious or untreated autoimmune disease (4)
• Immunosuppressed transplant recipients (4)

— Etiqueta de la FDA: BESREMi, PharmaEssentia USA, vigente desde el 25 de agosto de 2026. Leer la etiqueta completa en DailyMed →

Sobredosis de Ropeginterferon ALFA-2B

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).

Overdosage of BESREMi may result in influenza-like symptoms or other adverse reactions. There is no antidote to BESREMi overdosage. In case of an overdose, frequently monitor signs and symptoms for adverse reactions. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

— Etiqueta de la FDA: BESREMi, PharmaEssentia USA, vigente desde el 25 de agosto de 2026. Leer la etiqueta completa en DailyMed →

Presentaciones y vía de administración

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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.

• PharmaEssentia USA2 productos

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Fuentes

1. Etiqueta aprobada por la FDA en DailyMed (Biblioteca Nacional de Medicina) — BESREMi, PharmaEssentia USA, vigente desde el 25 de agosto de 2026; vía openFDA, datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
2. 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
3. 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
4. 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
5. 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

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