Ferric carboxymaltose

Para qué se usa Ferric carboxymaltose

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.

Injectafer is indicated for the treatment of: • iron deficiency anemia (IDA) in: adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron. adult patients who have non-dialysis dependent chronic kidney disease. • iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity. …

— Etiqueta de la FDA: Injectafer, American Regent, Inc., vigente desde el 19 de agosto de 2026. Leer la etiqueta completa en DailyMed →

Etiqueta citada: la de la presentación más común (injection, solution, intravenous), Injectafer, American Regent, Inc.; abarca 3 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 3 etiquetas para productos de este medicamento (distintos fabricantes y presentaciones); los usos pueden variar. Revise la etiqueta de su propio medicamento.

Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.

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.

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3 de 3 etiquetas de la FDA de este medicamento tienen advertencia en recuadro.

Ferric carboxymaltose: 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: SYMPTOMATIC HYPOPHOSPHATEMIA

• INJECTAFER can cause severe, prolonged hypophosphatemia associated with serious outcomes, including hospitalization, osteomalacia and fractures requiring clinical intervention [see Warnings and Precautions (5.1)].
• Hypophosphatemia has occurred in patients with normal baseline phosphate levels and without apparent risk factors for hypophosphatemia [see Warnings and Precautions (5.1)].

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• Check serum phosphate levels prior to a repeat course of treatment in patients at risk for low serum phosphate and in any patient who receives a repeat course of therapy within three months [see Dosage and Administration (2.1, 2.3)]. Correct pre-existing hypophosphatemia prior to administering INJECTAFER [see Warnings and Precautions (5.1)].
• Advise patients receiving INJECTAFER about the risk of hypophosphatemia and to report any signs and symptoms of hypophosphatemia (e.g., fatigue, muscle weakness or pain, bone and joint pain, bone fractures) [see Warnings and Precautions (5.1)]. WARNING: SYMPTOMATIC HYPOPHOSPHATEMIA See full prescribing information for complete boxed warning. INJECTAFER can cause severe, prolonged hypophosphatemia associated with serious outcomes, including hospitalization, osteomalacia and fractures requiring clinical intervention (5.1). Hypophosphatemia has occurred in patients with normal baseline phosphate levels and without apparent risk factors for hypophosphatemia (5.1). Check serum phosphate levels prior to a repeat course of treatment in patients at risk for low serum phosphate and in any patient who receives a repeat course of therapy within three months. Correct pre-existing hypophosphatemia prior to administering INJECTAFER (2.1, 2.3, 5.1). Advise patients receiving INJECTAFER about the risk of hypophosphatemia and to report any signs and symptoms of hypophosphatemia (e.g., fatigue, muscle weakness or pain, bone and joint pain, bone fractures) (5.1).

— Etiqueta de la FDA: Injectafer, American Regent, Inc., vigente desde el 19 de agosto de 2026. Leer la etiqueta completa en DailyMed →

Efectos secundarios de Ferric carboxymaltose

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 discussed in greater detail in other sections of the labeling: Symptomatic Hypophosphatemia [see Warnings and Precautions (5.1)] Hypersensitivity Reactions [see Warnings and Precautions (5.2)] Hypertension [see Warnings and Precautions (5.3)] Laboratory Test Alterations [see Warnings and Precautions (5.4)] The most common adverse reactions in adult patients (>2%) are nausea, hypertension, flushing, injection site reactions, erythema, hypophosphatemia, and dizziness.

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(6.1) The most common adverse reactions in pediatric patients (≥4%) are hypophosphatemia, injection site reactions, rash, headache, and vomiting. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact American Regent at 1-800-734-9236 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, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice. Adults In two randomized clinical studies [Studies 1 and 2, see Clinical Studies (14)], a total of 1,775 patients were exposed to Injectafer 15 mg/kg body weight up to a maximum single dose of 750 mg of iron on two occasions separated by at least 7 days up to a cumulative dose of 1,500 mg of iron. Adverse reactions reported by ≥1% of treated patients are shown in the following table. Table 2. Adverse reactions reported in ≥1% of Study Patients in Clinical Trials 1 and 2 Injectafer (N=1,775) % Pooled Comparators a (N=1,783) % Oral iron (N=253) % Nausea 7.2 2 1.2 Hypertension* 4 2 0.4 Flushing* 4 0.2 0 Injection site reactions* 3 3.2 0 Erythema* 3 0.6 0 Hypophosphatemia 2.1 0.1 0 Dizziness* 2.1 1.3 0.4 Vomiting 2 1 0.4 Injection Site Discoloration** 1.4 0.3 0 Headache* 1.3 1.2 0.4 Hepatic enzyme increased* 1.2 0.2 0 Dysgeusia* 1.2 2.1 0 Hypotension 1 2 0 Rash* 1 0.3 0 Constipation 0.5 0.9 3.2 a Includes oral iron and all formulations of IV iron other than Injectafer *Grouped Terms: Hypertension includes hypertension, blood pressure increased, and hypertensive crisis. Flushing includes flushing and hot flush. Injection site reactions include injection site extravasation, injection site discoloration, injection site pain, injection site irritation, injection site bruising, injection site reaction, injection site discomfort, injection site erythema, injection site hematoma, injection site hemorrhage, injection site pruritus, injection site rash, and injection site swelling. Erythema includes erythema and injection site erythema. Dizziness includes dizziness, balance disorder, and vertigo. **Injection site discoloration was also included in the injection site local administration reactions grouped term. Headache includes headache and migraine. Hepatic enzyme increased includes alanine aminotransferase increased and aspartate aminotransferase increased. Dysgeusia includes dysgeusia and ageusia. Rash includes rash, urticaria, skin exfoliation, blister, erythema multiforme, injection site rash, rash maculo-papular, and rash pruritic. Other adverse reactions reported by ≥0.5% of treated patients include abdominal pain, diarrhea, gamma glutamyl transferase increased, paresthesia, and sneezing.

— Etiqueta de la FDA: Injectafer, American Regent, Inc., vigente desde el 19 de agosto de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Dosis de Ferric carboxymaltose

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.

For patients weighing 50 kg or more, the recommended dosage is Injectafer 750 mg intravenously in two doses separated by at least 7 days for a total cumulative dose of 1,500 mg of iron per course. For adult patients weighing 50 kg or more, an alternative dose of Injectafer 15 mg/kg body weight up to a maximum of 1,000 mg intravenously may be administered as a single-dose per course.

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(2.2) For patients weighing less than 50 kg, the recommended dosage is Injectafer 15 mg/kg body weight intravenously in two doses separated by at least 7 days per course. (2.2) See Section 2.2, Table 1 for dosage in patients with iron deficiency and heart failure. (2.2) Injectafer treatment may be repeated if IDA or iron deficiency in heart failure reoccurs. (2.3) 2.1 Laboratory Testing Check serum phosphate levels prior to a repeat course of treatment in patients at risk for low serum phosphate and in any patient who receives a repeat course of therapy within three months [see Boxed Warning and Dosage and Administration (2.3)]. Correct pre-existing hypophosphatemia prior to administering Injectafer [see Warnings and Precautions (5.1)]. 2.2 Recommended Dosage Recommended Dosage for Treatment of Iron Deficiency Anemia For patients weighing 50 kg or more, the recommended dosage is: Injectafer 750 mg intravenously in two doses separated by at least 7 days for a total cumulative dose of 1,500 mg of iron per course. In adult patients, Injectafer 15 mg/kg body weight up to a maximum of 1,000 mg intravenously may be administered as a single-dose per course. For patients weighing less than 50 kg, the recommended dosage is Injectafer 15 mg/kg body weight intravenously in two doses separated by at least 7 days per course. Recommended Dosage in Patients with Iron Deficiency with Heart Failure See Table 1 for recommended dosage for treatment of iron deficiency in patients with heart failure and New York Heart Association class II/III to improve exercise capacity. Table 1: Recommended Dosage in Patients with Iron Deficiency with Heart Failure Weight less than 70 kg Weight 70 kg or more Hb (g/dL) Hb (g/dL) < 10 10 to 14 > 14 to < 15 < 10 10 to 14 > 14 to < 15 Day 1 1,000 mg 1,000 mg 500 mg 1,000 mg 1,000 mg 500 mg Week 6 500 mg No dose No dose 1,000 mg 500 mg No dose Administer a maintenance dose of 500 mg at 12, 24 and 36 weeks if serum ferritin <100 ng/mL or serum ferritin 100-300 ng/mL with transferrin saturation <20%. There are no data available to guide dosing beyond 36 weeks or with Hb ≥15 g/dL. 2.3 Repeat Dosage Courses Injectafer treatment may be repeated if IDA or iron deficiency in heart failure reoccurs. 2.4 Preparation and Administration Administer Injectafer intravenously, either as an undiluted slow intravenous push or by infusion. When administered via infusion, dilute up to 1,000 mg of iron in no more than 250 mL of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is not less than 2 mg of iron per mL and administer over at least 15 minutes.

— Etiqueta de la FDA: Injectafer, American Regent, Inc., vigente desde el 19 de agosto de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Ferric carboxymaltose 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 Parenteral iron administration may be associated with hypersensitivity reactions [see Warnings and Precautions (5.2)], which may have serious consequences, such as fetal bradycardia (see Clinical Considerations). Advise pregnant women of the potential risk to a fetus. Published studies and available data from postmarketing reports with intravenous Injectafer are insufficient to assess the risk of major birth defects and miscarriage.

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There are risks to the mother and fetus associated with untreated IDA in pregnancy as well as risks to the fetus associated with maternal severe hypersensitivity reactions (see Clinical Considerations). In animal reproduction studies, administration of ferric carboxymaltose to rabbits during the period of organogenesis caused adverse developmental outcomes including fetal malformations and increased implantation loss at maternally toxic doses of approximately 12% to 23% of the human weekly dose of 750 mg (based on body surface area). The estimated background risk of major birth defects and miscarriage for the indicated populations 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 in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Untreated IDA in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight. Fetal/Neonatal adverse reactions Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products (such as Injectafer) which may cause fetal bradycardia, especially during the second and third trimester. Data Human Data Published data from randomized controlled studies, prospective observational studies and retrospective studies on the use of ferric carboxymaltose in pregnant women have not reported an association with intravenous ferric carboxymaltose and major birth defects and miscarriage. However, these studies cannot establish or exclude the absence of any drug-related risk during pregnancy. Animal Data Administration of ferric carboxymaltose to rats as a one-hour intravenous infusion up to 30 mg/kg/day iron on gestation days 6 to 17 did not result in adverse embryonic or fetal findings. This daily dose in rats is approximately 40% of the human weekly dose of 750 mg based on body surface area. In rabbits, ferric carboxymaltose was administered as a one-hour infusion on gestation days 6 to 19 at iron doses of 4.5, 9, 13.5, and 18 mg/kg/day. Malformations were seen starting at the daily dose of 9 mg/kg (23% of the human weekly dose of 750 mg). Spontaneous abortions occurred starting at the daily iron dose of 4.5 mg/kg (12% of the human weekly dose of 750 mg based on body surface area). Pre-implantation loss was at the highest dose. Adverse embryonic or fetal effects were observed in the presence of maternal toxicity.

— Etiqueta de la FDA: Injectafer, American Regent, Inc., vigente desde el 19 de agosto de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Cuándo no se debe usar Ferric carboxymaltose

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

Injectafer is contraindicated in patients with a history of hypersensitivity to Injectafer or any of its components [see Warnings and Precautions (5.1)]. Hypersensitivity to Injectafer or any of its inactive components.

— Etiqueta de la FDA: Injectafer, American Regent, Inc., vigente desde el 19 de agosto de 2026. Leer la etiqueta completa en DailyMed →

Sobredosis de Ferric carboxymaltose

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).

Excessive dosages of Injectafer may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. A patient who received Injectafer 18,000 mg over 6 months developed hemosiderosis with multiple joint disorder, walking disability, and asthenia. In the postmarketing setting, hypophosphatemic osteomalacia has been reported in patients who have received repeated high-cumulative courses of Injectafer.

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Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

— Etiqueta de la FDA: Injectafer, American Regent, Inc., vigente desde el 19 de agosto de 2026. 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.

• Mylan Institutional LLC3 productos
• American Regent, Inc.3 productos
• Sandoz Inc1 producto

Historial de aprobación de la FDA

• NDA: Solicitud de nuevo medicamento (NDA): así se aprueba un medicamento nuevo, normalmente de marca.
• ANDA: Solicitud abreviada (ANDA): así se aprueba una versión genérica.

Aprobaciones de genéricos (3)

• ANDA212572Mylan Labs Ltd · 25 de junio de 2026
• ANDA217076Mylan · 25 de junio de 2026
• ANDA217769Mylan · 25 de junio de 2026

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

No aparece ningún retiro vinculado a estos productos (por su código NDC) en los informes de la FDA.

Identificadores oficiales

Siguientes pasos

• Encuentre una farmacia cerca de ustedPregunte qué precio le corresponde y si su producto está afectado por un retiro
• Últimos retiros de medicamentos de la FDATodos los medicamentos, los más recientes primero
• InjectaferPágina de marca: productos, fabricante y precio
• Fallo cardíacoEnfermedad que menciona la etiqueta: hospitales que la tratan
• Enfermedad renal crónicaEnfermedad que menciona la etiqueta: hospitales que la tratan
• Mylan Institutional LLCFabricante o distribuidor
• American Regent, Inc.Fabricante o distribuidor
• Sandoz 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) — Injectafer, American Regent, Inc., vigente desde el 19 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

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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