Lutetium lu 177 dotatate

Para qué se usa Lutetium lu 177 dotatate

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.

LUTATHERA is indicated for the treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. …

— Etiqueta de la FDA: Lutathera, Advanced Accelerator Applications USA, Inc, vigente desde el 15 de enero de 2026. Leer la etiqueta completa en DailyMed →

Etiqueta citada: la de la presentación más común (injection, intravenous), Lutathera, Advanced Accelerator Applications USA, 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.

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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.

La etiqueta citada arriba no tiene advertencia en recuadro.

Efectos secundarios de Lutetium lu 177 dotatate

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: Myelosuppression [see Warnings and Precautions (5.2)] Secondary Myelodysplastic Syndrome and Leukemia [see Warnings and Precautions (5.3)] Renal Toxicity [see Warnings and Precautions (5.4)] Hepatotoxicity [see Warnings and Precautions (5.5)] Hypersensitivity Reactions [see Warnings and Precautions (5.6)] Neuroendocrine Hormonal Crisis [see Warnings and Precautions (5.7)] Most common Grade 3-4 adverse reactions (≥ 4% with a higher incidence in LUTATHERA arm) are lymphopenia, increased GGT, vomiting, nausea, increased AST, increased ALT, hyperglycemia and hypokalemia.

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(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 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 data in WARNINGS AND PRECAUTIONS reflect exposure to LUTATHERA in 111 patients with advanced, progressive midgut neuroendocrine tumors (NETTER-1). Safety data in WARNINGS AND PRECAUTIONS were also obtained in an additional 22 patients in a non-randomized pharmacokinetic sub-study of NETTER-1 and in a subset of patients (811 of 1214) with advanced somatostatin receptor-positive tumors enrolled in ERASMUS [see Warnings and Precautions (5)]. Adult Population NETTER-1 The safety data of LUTATHERA with octreotide was evaluated in NETTER-1 [see Clinical Studies (14.1)]. Patients with progressive, somatostatin receptor-positive midgut carcinoid tumors received LUTATHERA 7.4 GBq (200 mCi) administered every 8 to 16 weeks concurrently with the recommended amino acid solution and with long-acting octreotide (30 mg administered by intramuscular injection within 24 hours of each LUTATHERA dose) (N = 111), or high-dose octreotide (defined as long-acting octreotide 60 mg by intramuscular injection every 4 weeks) (N = 112) [see Clinical Studies (14.1)]. Among patients receiving LUTATHERA with octreotide, 79% received a cumulative dose > 22.2 GBq (> 600 mCi) and 76% of patients received all four planned doses. Six percent (6%) of patients required a dose reduction and 13% of patients discontinued LUTATHERA. Five patients discontinued LUTATHERA for renal-related events and 4 discontinued for hematological toxicities. Table 5 and Table 6 summarize the incidence of adverse reactions and laboratory abnormalities, respectively. The most common Grade 3-4 adverse reactions occurring with a greater frequency among patients receiving LUTATHERA with octreotide compared to patients receiving high-dose octreotide include: lymphopenia (44%), increased gamma-glutamyltransferase (GGT) (20%), vomiting (7%), nausea and increased aspartate aminotransferase (AST) (5% each), and increased alanine aminotransferase (ALT), hyperglycemia and hypokalemia (4% each). Table 5. Adverse Reactions Occurring at Higher Incidence in Patients Receiving LUTATHERA with Long-Acting Octreotide Compared to High-Dose Long-Acting Octreotide (Between Arm Difference of ≥ 5% All Grades or ≥ 2% Grades 3-4) a a National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.

— Etiqueta de la FDA: Lutathera, Advanced Accelerator Applications USA, Inc, vigente desde el 15 de enero de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Interacciones de Lutetium lu 177 dotatate

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.

Somatostatin Analogs: Discontinue long-acting analogs at least 4 weeks and short-acting octreotide at least 24 hours prior to each LUTATHERA dose. (2.3, 7.1) 7.1 Somatostatin Analogs Somatostatin and its analogs competitively bind to somatostatin receptors and may interfere with the efficacy of LUTATHERA. Discontinue long-acting somatostatin analogs at least 4 weeks and short-acting octreotide at least 24 hours prior to each LUTATHERA dose.

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Administer short- and long-acting octreotide during LUTATHERA treatment as recommended [see Dosage and Administration (2.3)]. 7.2 Glucocorticoids Glucocorticoids can induce down-regulation of subtype 2 somatostatin receptors (SSTR2). Avoid repeated administration of high doses of glucocorticoids during treatment with LUTATHERA.

— Etiqueta de la FDA: Lutathera, Advanced Accelerator Applications USA, Inc, vigente desde el 15 de enero de 2026. Leer la etiqueta completa en DailyMed →

Dosis de Lutetium lu 177 dotatate

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.

Verify pregnancy status of females of reproductive potential prior to initiating LUTATHERA. (2.1) Administer 7.4 GBq (200 mCi) every 8 weeks (± 1 week) for a total of 4 doses. (2.2) Administer long-acting octreotide 30 mg intramuscularly 4 to 24 hours after each LUTATHERA dose and short-acting octreotide for symptomatic management.

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(2.3) Continue long-acting octreotide 30 mg intramuscularly every 4 weeks after completing LUTATHERA until disease progression or for 18 months following treatment initiation. (2.3) Administer antiemetics before recommended amino acid solution. (2.3) Initiate recommended intravenous amino acid solution 30 minutes before LUTATHERA infusion; continue during and for at least 3 hours after LUTATHERA infusion. Do not decrease dose of amino acid solution if LUTATHERA dose is reduced. (2.3) 2.1 Important Safety Instructions LUTATHERA is a radiopharmaceutical; handle with appropriate safety measures to minimize radiation exposure [see Warnings and Precautions (5.1)]. Use waterproof gloves and effective radiation shielding when handling LUTATHERA. Radiopharmaceuticals, including LUTATHERA, should be used by or under the control of healthcare providers who are qualified by specific training and experience in the safe use and handling of radiopharmaceuticals, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radiopharmaceuticals. Verify pregnancy status of females of reproductive potential prior to initiating LUTATHERA [see Use in Specific Populations (8.1, 8.3)]. Monitor patients closely for signs and symptoms of hypersensitivity reactions during and following the LUTATHERA administration for a minimum of 2 hours in a setting where cardiopulmonary resuscitation medication and equipment are available [see Warnings and Precautions (5.6)]. 2.2 Recommended Dosage The recommended LUTATHERA dosage for adult and pediatric patients 12 years and older is 7.4 GBq (200 mCi) every 8 weeks (± 1 week) for a total of 4 doses. Administer premedications and concomitant medications as recommended [see Dosage and Administration (2.3)]. 2.3 Premedications and Concomitant Medications Somatostatin Analogs Before initiating LUTATHERA treatment: Discontinue long-acting somatostatin analogs (e.g., long-acting octreotide) at least 4 weeks prior to initiating LUTATHERA. Administer short-acting octreotide as needed; discontinue at least 24 hours prior to initiating LUTATHERA [see Drug Interactions (7.1)]. During LUTATHERA treatment: Administer long-acting octreotide 30 mg intramuscularly between 4 to 24 hours after each LUTATHERA dose. Do not administer long-acting octreotide within 4 weeks prior to each subsequent LUTATHERA dose. Short-acting octreotide may be given for symptomatic management during LUTATHERA treatment but must be withheld at least 24 hours before each LUTATHERA dose.

— Etiqueta de la FDA: Lutathera, Advanced Accelerator Applications USA, Inc, vigente desde el 15 de enero de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Lutetium lu 177 dotatate 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 Based on its mechanism of action, LUTATHERA can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)]. There are no available data on LUTATHERA use in pregnant women. No animal studies using lutetium Lu 177 dotatate have been conducted to evaluate its effect on female reproduction and embryo-fetal development; however, radioactive emissions, including those from LUTATHERA, can cause fetal harm.

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Advise pregnant women of the potential risk to a fetus. 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.

— Etiqueta de la FDA: Lutathera, Advanced Accelerator Applications USA, Inc, vigente desde el 15 de enero 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.

• Curium US LLC1 producto
• Advanced Accelerator Applications USA, Inc1 producto

Historial de aprobación de la FDA

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Escasez

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• Curium US LLCFabricante o distribuidor
• Advanced Accelerator Applications USA, IncFabricante o distribuidor
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Fuentes

1. Etiqueta aprobada por la FDA en DailyMed (Biblioteca Nacional de Medicina) — Lutathera, Advanced Accelerator Applications USA, Inc, vigente desde el 15 de enero 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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