Epoetin alfa-epbx

Para qué se usa Epoetin alfa-epbx

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.

RETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for: • Treatment of anemia due to o Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis. o Zidovudine in patients with Human Immunodeficiency Virus (HIV) infection. o The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. …

— Etiqueta de la FDA: Retacrit, Pfizer Laboratories Div Pfizer Inc, vigente desde el 22 de junio de 2025. Leer la etiqueta completa en DailyMed →

Etiqueta citada: la de la presentación más común (injection, solution, intravenous), Retacrit, Pfizer Laboratories Div Pfizer Inc; abarca 7 productos del directorio NDC de la FDA. Las citas sobre efectos secundarios, interacciones, dosis y embarazo de abajo vienen de esta misma etiqueta.

La FDA tiene 4 etiquetas para productos de este medicamento (distintos fabricantes y presentaciones); los usos pueden variar. Revise la etiqueta de su propio medicamento.

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Enfermedades que menciona la etiqueta

Estos nombres aparecen tal cual en la sección «Indications and Usage» de la etiqueta (según una tabla revisada). Cada página muestra los hospitales cuyos sitios web mencionan la enfermedad.

Especialidades médicas relacionadas

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. Leerla en la etiqueta completa →

4 de 4 etiquetas de la FDA de este medicamento tienen advertencia en recuadro.

Epoetin alfa-epbx: 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: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE See full prescribing information for complete boxed warning.

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Chronic Kidney Disease:

• In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL (5.1).
• No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks (2.2).
• Use the lowest RETACRIT dose sufficient to reduce the need for red blood cell (RBC) transfusions (5.1). Cancer:
• ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers (5.2).
• Use the lowest dose to avoid RBC transfusions (2.4).
• Use ESAs only for anemia from myelosuppressive chemotherapy (1.3).
• ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure (1.5).
• Discontinue following the completion of a chemotherapy course (2.4). Perisurgery:
• Due to increased risk of deep venous thrombosis (DVT), DVT prophylaxis is recommended (5.1). Chronic Kidney Disease:
• In controlled trials, patients with chronic kidney disease (CKD) experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL [see Warnings and Precautions (5.1)].
• No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks [see Dosage and Administration (2.2)].
• Use the lowest RETACRIT dose sufficient to reduce the need for red blood cell (RBC) transfusions [see Warnings and Precautions (5.1)]. Cancer:
• ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers [see Warnings and Precautions (5.2)].
• To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC transfusions [see Dosage and Administration (2.4)].
• Use ESAs only for anemia from myelosuppressive chemotherapy [see Indications and Usage (1.3)].
• ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure [see Indications and Usage (1.5)].
• Discontinue following the completion of a chemotherapy course [see Dosage and Administration (2.4)]. Perisurgery:
• Due to increased risk of deep venous thrombosis (DVT), DVT prophylaxis is recommended [see Dosage and Administration (2.5), Warnings and Precautions (5.1)].

— Etiqueta de la FDA: Retacrit, Pfizer Laboratories Div Pfizer Inc, vigente desde el 22 de junio de 2025. Leer la etiqueta completa en DailyMed →

Efectos secundarios de Epoetin alfa-epbx

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 discussed in greater detail in other sections of the label:

• Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism [see Warnings and Precautions (5.1)]
• Increased mortality and/or increased risk of tumor progression or recurrence in Patients with Cancer [see Warnings and Precautions (5.2)]
• Hypertension [see Warnings and Precautions (5.3)]
• Seizures [see Warnings and Precautions (5.4)]
• PRCA [see Warnings and Precautions (5.6)]
• Serious allergic reactions [see Warnings and Precautions (5.7)]
• Severe Cutaneous Reactions [see Warnings and Precautions (5.8)]
• Patients with CKD: Adverse reactions in ≥ 5% of epoetin alfa-treated patients in clinical studies were hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion, and upper respiratory tract infection (6.1).

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• Patients on Zidovudine due to HIV infection: Adverse reactions in ≥ 5% of epoetin alfa-treated patients in clinical studies were pyrexia, cough, rash, and injection site irritation (6.1).
• Patients with Cancer on Chemotherapy: Adverse reactions in ≥ 5% of epoetin alfa-treated patients in clinical studies were nausea, vomiting, myalgia, arthralgia, stomatitis, cough, weight decrease, leukopenia, bone pain, rash, hyperglycemia, insomnia, headache, depression, dysphagia, hypokalemia, and thrombosis (6.1).
• Surgery Patients: Adverse reactions in ≥ 5% of epoetin alfa-treated patients in clinical studies were nausea, vomiting, pruritus, headache, injection site pain, chills, deep vein thrombosis, cough, and hypertension (6.1). To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc., a Pfizer Company, at 1-800-438-1985, 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 other drugs and may not reflect the rates observed in practice. Patients with Chronic Kidney Disease Adult Patients Three double-blind, placebo-controlled studies, including 244 patients with CKD on dialysis, were used to identify the adverse reactions to epoetin alfa. In these studies, the mean age of patients was 48 years (range: 20 to 80 years). One hundred and thirty-three (55%) patients were men. The racial distribution was as follows: 177 (73%) patients were white, 48 (20%) patients were black, 4 (2%) patients were Asian, 12 (5%) patients were other, and racial information was missing for 3 (1%) patients. Two double-blind, placebo-controlled studies, including 210 patients with CKD not on dialysis, were used to identify the adverse reactions to epoetin alfa. In these studies, the mean age of patients was 57 years (range: 24 to 79 years). One hundred and twenty-one (58%) patients were men. The racial distribution was as follows: 164 (78%) patients were white, 38 (18%) patients were black, 3 (1%) patients were Asian, 3 (1%) patients were other, and racial information was missing for 2 (1%) patients. The adverse reactions with a reported incidence of ≥ 5% in epoetin alfa-treated patients and that occurred at a ≥ 1% higher frequency than in placebo-treated patients are shown in the table below: Table 3.

— Etiqueta de la FDA: Retacrit, Pfizer Laboratories Div Pfizer Inc, vigente desde el 22 de junio de 2025. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Dosis de Epoetin alfa-epbx

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.

• Evaluate iron status before and during treatment and maintain iron repletion. Correct or exclude other causes of anemia before initiating treatment (2.1).
• In pregnant women, lactating women, neonates, infants: Use only single-dose vials (2.1).
• Patients with CKD: Initial dose: 50 to 100 Units/kg 3 times weekly (adults) and 50 Units/kg 3 times weekly (pediatric patients). Individualize maintenance dose. Intravenous route recommended for patients on hemodialysis (2.2).

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• Patients on Zidovudine due to HIV infection: 100 Units/kg 3 times weekly (2.3).
• Patients with Cancer on Chemotherapy: 40,000 Units weekly or 150 Units/kg 3 times weekly (adults); 600 Units/kg intravenously weekly (pediatric patients ≥ 5 years) (2.4).
• Surgery Patients: 300 Units/kg per day daily for 15 days or 600 Units/kg weekly (2.5). 2.1 Important Dosing Information Evaluation of Iron Stores and Nutritional Factors Evaluate the iron status in all patients before and during treatment. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. Monitoring of Response to Therapy Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating RETACRIT. Following initiation of therapy and after each dose adjustment, monitor hemoglobin weekly until the hemoglobin level is stable and sufficient to minimize the need for RBC transfusion. Selection of Formulation In pregnant women, lactating women, neonates, and infants use only single-dose vials (the benzyl alcohol-free formulation) [see Contraindications (4) and Use in Specific Populations (8.1, 8.2, and 8.4)]. 2.2 Patients with Chronic Kidney Disease In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered ESAs to target a hemoglobin level of greater than 11 g/dL. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Individualize dosing and use the lowest dose of RETACRIT sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse reactions [see Boxed Warning and Clinical Studies (14)]. For all patients with CKD: When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin excursion may not require a dosing change.
• Do not increase the dose more frequently than once every 4 weeks. Decreases in dose can occur more frequently. Avoid frequent dose adjustments.
• If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of RETACRIT by 25% or more as needed to reduce rapid responses.

— Etiqueta de la FDA: Retacrit, Pfizer Laboratories Div Pfizer Inc, vigente desde el 22 de junio de 2025. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Epoetin alfa-epbx 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 RETACRIT from multiple-dose vials contains benzyl alcohol and is contraindicated in pregnant women [see Contraindications (4)]. When therapy with RETACRIT is needed during pregnancy, use a benzyl alcohol-free formulation (i.e., single-dose vial). Do not mix RETACRIT with bacteriostatic saline when administering to pregnant women because it contains benzyl alcohol (see Clinical Considerations) [see Dosage and Administration (2.1)].

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The limited available data on epoetin alfa use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes. In animal reproductive and developmental toxicity studies, adverse fetal effects including embryo-fetal death, skeletal anomalies, and growth defects occurred when pregnant rats received epoetin alfa at doses approximating the clinical recommended starting doses (see Data). Consider the benefits and risks of RETACRIT single-dose vials for the mother and possible risks to the fetus when prescribing RETACRIT to a pregnant woman. 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 risks of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions The multiple-dose vials of RETACRIT contain benzyl alcohol. The preservative benzyl alcohol has been associated with serious adverse reactions and death when administered intravenously to neonates and infants [see Warnings and Precautions (5.9), Use in Specific Populations (8.4)]. There is a potential for similar risks to fetuses exposed to benzyl alcohol in utero. Data Human Data There are reports of pregnant women with anemia alone or anemia associated with severe renal disease and other hematologic disorders who received epoetin alfa. Polyhydramnios and intrauterine growth restriction were reported in women with chronic renal disease, which is associated with an increased risk for these adverse pregnancy outcomes. Due to the limited number of exposed pregnancies and multiple confounding factors (such as underlying maternal conditions, other maternal medications, and gestational timing of exposure), these published case reports and studies do not reliably estimate the frequency, presence or absence of adverse outcomes. Animal Data When rats received epoetin alfa at doses greater than or equal to 100 Units/kg/day during mating and through early pregnancy (dosing stopped prior to organogenesis), there were slight increases in the incidences of pre- and post-implantation loss, and a decrease in live fetuses in the presence of maternal toxicity (red limbs/pinna, focal splenic capsular toxicity, increased organ weights). This animal dose level of 100 Units/kg/day may approximate the clinical recommended starting dose, depending on the treatment indication.

— Etiqueta de la FDA: Retacrit, Pfizer Laboratories Div Pfizer Inc, vigente desde el 22 de junio de 2025. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Cuándo no se debe usar Epoetin alfa-epbx

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

RETACRIT is contraindicated in patients with:

• Uncontrolled hypertension [see Warnings and Precautions (5.3)].
• Pure red cell aplasia (PRCA) that begins after treatment with RETACRIT or other erythropoietin protein drugs [see Warnings and Precautions (5.6)].
• Serious allergic reactions to RETACRIT or other epoetin alfa products [see Warnings and Precautions (5.7)].

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RETACRIT from multiple-dose vials contains benzyl alcohol and is contraindicated in:

• Neonates, infants, pregnant women, and lactating women [see Warnings and Precautions (5.9), Use in Specific Populations (8.1, 8.2, and 8.4)].
• Uncontrolled hypertension (4).
• Pure red cell aplasia (PRCA) that begins after treatment with RETACRIT or other erythropoietin protein drugs (4).
• Serious allergic reactions to RETACRIT or other epoetin alfa products (4).
• Use of the multiple-dose vials containing benzyl alcohol in neonates, infants, pregnant women, and lactating women (4).

— Etiqueta de la FDA: Retacrit, Pfizer Laboratories Div Pfizer Inc, vigente desde el 22 de junio de 2025. Leer la etiqueta completa en DailyMed →

Sobredosis de Epoetin alfa-epbx

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).

RETACRIT overdosage can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of RETACRIT dosage and/or with phlebotomy, as clinically indicated [see Clinical Pharmacology (12.2)]. Cases of severe hypertension have been observed following overdose with ESAs [see Warnings and Precautions (5.3)].

— Etiqueta de la FDA: Retacrit, Pfizer Laboratories Div Pfizer Inc, vigente desde el 22 de junio de 2025. Leer la etiqueta completa en DailyMed →

Presentaciones y vía de administración

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.

• Janssen Products, LP7 productos
• Pfizer Laboratories Div Pfizer Inc7 productos
• Amgen, Inc6 productos
• Vifor (International) Inc.6 productos

Historial de aprobación de la FDA

• BLA: Solicitud de licencia de productos biológicos (BLA): así se aprueba un medicamento biológico (hecho a partir de células vivas).

Escasez

La lista de escasez de la FDA no incluye estos productos.

Base de datos de escasez de medicamentos de la FDA →

Retiros del mercado

De los informes de la FDA, vinculados por el código NDC del producto. Un retiro suele afectar solo a lotes concretos: revise el número de lote del envase y pregunte a su farmacéutico. No deje un medicamento por su cuenta.

1. 13 de septiembre de 2017 · Clase II · Cerrado por la FDA · D-1173-2017

   Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.

   Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1 mL vials (NDC 59676-310-01), b) box of 25 single use 1 mL vials (NDC 59676-310-02), Rx Only, Manufactured by: Amgen, Inc. Thousand Oaks, CA 91 — Amgen, Inc.

2. 4 de agosto de 2017 · Clase II · Cerrado por la FDA · D-1086-2017

   Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.

   Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320-1799, Manufactured for: Janssen Products, LP Horsham, PA 19044 — Amgen, Inc.

Identificadores oficiales

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• Enfermedad renal crónicaEnfermedad que menciona la etiqueta: hospitales que la tratan
• Janssen Products, LPFabricante o distribuidor
• Pfizer Laboratories Div Pfizer IncFabricante o distribuidor
• Amgen, IncFabricante o distribuidor
• Todos los medicamentos con receta de la A a la ZBusque por nombre genérico, de marca o en español

Fuentes

1. Etiqueta aprobada por la FDA en DailyMed (Biblioteca Nacional de Medicina) — Retacrit, Pfizer Laboratories Div Pfizer Inc, vigente desde el 22 de junio de 2025; 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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