Octreotida (octreotide)

Para qué se usa Octreotida

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.

MYCAPSSA is indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. MYCAPSSA is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide (‎ 1 ).

— Etiqueta de la FDA: Mycapssa, Chiesi USA, Inc., vigente desde el 24 de julio de 2025. Leer la etiqueta completa en DailyMed →

Etiqueta citada: la de la presentación más común (capsule, delayed release, oral), Mycapssa, Chiesi 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.

La FDA tiene 2 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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0 de 2 etiquetas de la FDA de este medicamento tienen advertencia en recuadro.

Efectos secundarios de Octreotida

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 important adverse reactions are described below and elsewhere in the labeling: Cholelithiasis and Complications of Cholelithiasis [see Warnings and Precautions (‎5.1)] Hyperglycemia and Hypoglycemia [see Warnings and Precautions (‎5.2)] Thyroid Function Abnormalities [see Warnings and Precautions (‎5.3)] Cardiac Function Abnormalities [see Warnings and Precautions (‎5.4)] Steatorrhea and Malabsorption of Dieatary Fats [see Warnings and Precautions (‎5.5)] Changes in Vitamin B 12 Levels [see Warnings and Precautions (5.6)] Most common adverse reactions (incidence >10 %) are nausea, diarrhea, headache, arthralgia, asthenia, hyperhidrosis, peripheral swelling, blood glucose increased, vomiting, abdominal discomfort, dyspepsia, sinusitis, osteoarthritis (‎ 6.1).

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To report SUSPECTED ADVERSE REACTIONS, contact Chiesi Farmaceutici S.p.A. at 1-888-661-9260 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Studies 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. MYCAPSSA has been evaluated in patients with acromegaly in a placebo-controlled study [see Clinical Studies (‎14)] and an open-label baseline-controlled study. The data reflect exposure of 183 patients to MYCAPSSA for a mean duration of 29 weeks. In the overall study population, 56% were female and the average age of patients was 54.3 years. Adverse reactions occurring ≥ 5% and greater than placebo for the placebo-controlled study are presented in Table 1 and adverse reactions occurring ≥ 5% in the open-label study are presented in Table 2. Table 1: Adverse Reactions Occurring ≥ 5% and Greater than Placebo in a Placebo-Controlled Study with MYCAPSSA in Acromegaly Patients MYCAPSSA % (N=28) PLACEBO % (N=28) Diarrhea 29 21 Nausea 21 11 Blood glucose increased Includes blood glucose increased, hyperglycemia and glycosylated hemoglobin increased 14 7 Vomiting 14 0 Abdominal discomfort 14 11 Dyspepsia 11 4 Sinusitis 11 0 Osteoarthritis 11 0 Urinary tract infection 7 4 Pain 7 0 Large intestine polyp 7 0 Cholelithiasis 7 4 Table 2: Adverse Reactions Occurring ≥ 5% in an Open-Label Study with MYCAPSSA in Acromegaly Patients MYCAPSSA % (N=155) Headache 33 Nausea 30 Arthralgia 26 Asthenia 22 Hyperhidrosis 21 Diarrhea 18 Peripheral swelling 16 Dyspepsia 8 Abdominal pain upper 8 Abdominal distension 7 Nasopharyngitis 7 Influenza 7 Blood glucose increased Includes blood glucose increased, hyperglycemia and impaired fasting glucose 6 Vomiting 6 Flatulence 6 Back pain 6 Abdominal pain 5 Dizziness 5 Fatigue 5 Upper respiratory tract infection 5 Hypertension 5 Other Adverse Reactions Gallbladder Abnormalities In the placebo-controlled study, in patients treated with MYCAPSSA, acute cholecystitis occurred in 4% of patients. In the open-label study, cholelithiasis occurred in 4.5% of patients and bile duct obstruction, bile duct stone, acute cholecystitis and jaundice occurred in 1% of patients each. Hypoglycemia/Hyperglycemia In the placebo-controlled study, 18% of patients treated with MYCAPSSA and 4% of patients treated with placebo developed at least one glucose value above the upper normal limit. All patients with abnormal glucose values were asymptomatic. Asymptomatic hypoglycemia was reported in 4% of patients. In the open-label study 16% of patients developed a glucose value above the upper limit of normal.

— Etiqueta de la FDA: Mycapssa, Chiesi USA, Inc., vigente desde el 24 de julio de 2025. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Interacciones de Octreotida

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.

Proton Pump Inhibitors, H2-receptor Antagonists, or Antacids: may decrease bioavailability of MYCAPSSA and the MYCAPSSA dose may need to be increased (‎ 7). Cyclosporine: may have decreased bioavailability and require dose adjustment (7). Insulin and Antidiabetic Drugs: patients receiving insulin or antidiabetic drugs agents may require dose adjustment (‎ 7). Digoxin: exposure may be decreased and assessment of clinical response to digoxin should be performed (‎ 7).

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Lisinopril: bioavailability may be increased, monitor patient's blood pressure and adjust dose of lisinopril if needed (‎ 7). Levonorgestrel: counsel women to use an alternative non-hormonal method of contraception or a back-up method when MYCAPSSA is used with combined oral contraceptives (‎ 7). Bromocriptine: dose adjustment of bromocriptine may be necessary (‎ 7). Beta Blocker and Calcium Channel Blockers: dose adjustment of beta blockers or calcium channel blockers may be necessary (‎ 7). Drugs Metabolized by CYP 450 Enzymes: concomitant use with other drugs mainly metabolized by CYP3A4 that have a narrow therapeutic index (e.g., quinidine) should be used with caution and increased monitoring may be required (‎ 7). 7.1 Effects of Other Drugs on MYCAPSSA Proton Pump Inhibitors, H2-receptor Antagonists, or Antacids Clinical Impact: Concomitant administration of MYCAPSSA with esomeprazole resulted in a decrease in the bioavailability for MYCAPSSA [See Clinical Pharmacology (‎12.3)]. Drugs that alter the pH of the upper GI tract (e.g., other proton pump inhibitors (PPIs), H2-receptor antagonists, and antacids) may alter the absorption of MYCAPSSA and lead to a reduction in bioavailability. Intervention: Co-administration of MYCAPSSA with PPIs, H2-blockers, or antacids may require increased doses of MYCAPSSA. 7.2 Effects of MYCAPSSA on Other Drugs Cyclosporine Clinical Impact: Concomitant administration of MYCAPSSA with cyclosporine resulted in a decrease in cyclosporine bioavailability [see Clinical Pharmacology (‎12.3)]. Intervention: Adjustment of cyclosporine dose to maintain therapeutic levels may be necessitated. Insulin and Antidiabetic Drugs Clinical Impact: MYCAPSSA inhibits the secretion of insulin and glucagon. Intervention: Monitor blood glucose levels in diabetic patients upon MYCAPSSA initiation and subsequent dose adjustment. Patients receiving insulin or antidiabetic drugs agents may require dose adjustment of these therapeutic agents. Digoxin Clinical Impact: Concomitant administration of MYCAPSSA with digoxin resulted in a decrease in digoxin peak exposure [see Clinical Pharmacology (‎12.3)]. Intervention: Digoxin has a narrow therapeutic ratio and careful assessment of clinical response should be performed when digoxin is concomitantly administered with MYCAPSSA. Lisinopril Clinical Impact: Concomitant administration of MYCAPSSA increases lisinopril bioavailability [see Clinical Pharmacology (‎12.3)]. Intervention: Monitor patient's blood pressure and adjust the dosage of lisinopril if needed. Levonorgestrel Clinical Impact: Concomitant administration of MYCAPSSA with levonorgestrel decreases levonorgestrel bioavailability [see Clinical Pharmacology (‎12.3)].

— Etiqueta de la FDA: Mycapssa, Chiesi USA, Inc., vigente desde el 24 de julio de 2025. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Dosis de Octreotida

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.

Take MYCAPSSA orally with a glass of water on an empty stomach, at least 1 hour before a meal or at least 2 hours after a meal (‎ 2.1). Initiate MYCAPSSA at a dosage of 40 mg daily, administered as 20 mg orally twice daily (‎ 2.2). Monitor insulin-like growth factor 1 (IGF-1) levels and patient's signs and symptoms every two weeks during the dose titration or as indicated (‎ 2.2). Titrate the MYCAPSSA dosage, based on IGF-1 levels and patient's signs and symptoms.

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Increase the dosage in increments of 20 mg (2.2). The maximum recommended dosage is 80 mg daily (‎ 2.2). Once the maintenance dosage of MYCAPSSA is achieved, monitor IGF-1 levels and patient's signs and symptoms monthly or as indicated (‎ 2.2). For patients with end-stage renal disease, initiate at a dosage of 20 mg orally once daily. Titrate and adjust the maintenance dosage based on IGF-1 levels, patient's signs and symptoms and tolerability (‎ 2.4). 2.1 Important Administration Instructions Take MYCAPSSA orally with a glass of water on an empty stomach, at least 1 hour before a meal or at least 2 hours after a meal. Swallow MYCAPSSA capsules whole. Do not crush or chew the capsules. 2.2 Recommended Dosage, Titration, and Monitoring Initiate MYCAPSSA at a dosage of 40 mg daily, administered as 20 mg orally twice daily. Monitor insulin-like growth factor 1 (IGF-1) levels and patient's signs and symptoms every two weeks during the dose titration or as indicated. Titrate the MYCAPSSA dosage based on IGF-1 levels and patient's signs and symptoms. Increase the dosage in increments of 20 mg daily. For MYCAPSSA dosages of 60 mg daily, administer as 40 mg in the morning and 20 mg in the evening. For MYCAPSSA dosages of 80 mg daily, administer as 40 mg twice daily. The maximum recommended dosage of MYCAPSSA is 80 mg daily. Once the maintenance dosage of MYCAPSSA is achieved, monitor IGF-1 levels and patient's signs and symptoms monthly or as indicated. 2.3 Dosage Interruptions and Modifications If IGF-1 levels remain above the upper normal limit after treatment with the maximum recommended dosage of 80 mg daily or the patient cannot tolerate treatment with MYCAPSSA, consider discontinuing MYCAPSSA and switching patient to another somatostatin analog. Withdraw MYCAPSSA therapy periodically to assess disease activity. If IGF-1 levels increase and signs and symptoms recur, resume MYCAPSSA therapy. 2.4 Recommended Dosage in Patients with End Stage Renal Disease For patients with end-stage renal disease, initiate MYCAPSSA at a dosage of 20 mg orally once daily. Titrate and adjust the maintenance dosage of MYCAPSSA based on IGF-1 levels, patient's signs and symptoms and tolerability [see Dosage and Administration (‎2.2, ‎ 2.3), Use in Specific Populations (‎8.6)]. 2.5 Dosage Modifications with Concomitant Use of Proton Pump Inhibitors, H2-receptor Antagonists, or Antacids Patients taking proton pump inhibitors, H2-receptor antagonists, or antacids concomitantly with MYCAPSSA may require increased dosages of MYCAPSSA [see Drug Interactions (‎7.1)].

— Etiqueta de la FDA: Mycapssa, Chiesi USA, Inc., vigente desde el 24 de julio de 2025. Leer la etiqueta completa en DailyMed →

Octreotida 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 data from case reports with octreotide acetate use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with MYCAPSSA.

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No adverse developmental effects were observed with intravenous administration of octreotide to pregnant rats and rabbits during organogenesis at doses 7 and 13 times, respectively, the clinical dose based on octreotide injection body surface area. Transient growth retardation, with no impact on postnatal development, was observed in rat offspring from a pre- and post-natal study of octreotide at intravenous doses below the clinical dose based on octreotide injection body surface area (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. Data Animal Data In embryo-fetal development studies in rats and rabbits, pregnant animals received intravenous doses of octreotide up to 1 mg/kg/day during the period of organogenesis. A slight reduction in body weight gain was noted in pregnant rats at 0.1 and 1 mg/kg/day. There were no maternal effects in rabbits or embryo-fetal effects in either species up to the maximum dose tested. At 1 mg/kg/day in rats and rabbits, the dose multiple was approximately 7 and 13 times, respectively, the clinical dose based on octreotide injection body surface area. In a pre- and post-natal development rat study at intravenous doses of 0.02-1 mg/kg/day, a transient growth retardation of the offspring was observed at all doses which was possibly a consequence of growth hormone inhibition by octreotide. The doses attributed to the delayed growth are below the clinical dose based on octreotide injection body surface area.

— Etiqueta de la FDA: Mycapssa, Chiesi USA, Inc., vigente desde el 24 de julio de 2025. Leer la etiqueta completa en DailyMed →

Cuándo no se debe usar Octreotida

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

Hypersensitivity to octreotide or any of the components of MYCAPSSA. Anaphylactoid reactions, including anaphylactic shock, have been reported in patients receiving octreotide [see Adverse Reactions (‎6.3)]. Hypersensitivity to octreotide or any of the components of MYCAPSSA.

— Etiqueta de la FDA: Mycapssa, Chiesi USA, Inc., vigente desde el 24 de julio de 2025. Leer la etiqueta completa en DailyMed →

Sobredosis de Octreotida

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).

A limited number of accidental overdoses of injectable octreotide acetate in adults has been reported. The doses ranged from 2.4 mg/day to 6 mg/day administered by continuous infusion or subcutaneously 1.5 mg three times a day. Adverse reactions in some patients included arrhythmia, hypotension, cardiac arrest, brain hypoxia, pancreatitis, hepatic steatosis, hepatomegaly, lactic acidosis, flushing, diarrhea, lethargy, weakness, and weight loss.

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If overdose occurs, contact Poison Control (1-800-222-1222) for latest recommendations.

— Etiqueta de la FDA: Mycapssa, Chiesi USA, Inc., vigente desde el 24 de julio 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.

• Amryt Pharmaceuticals Designated Activity Company1 producto
• Chiesi USA, Inc.1 producto

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• Chiesi USA, Inc.Fabricante o distribuidor
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Fuentes

1. Etiqueta aprobada por la FDA en DailyMed (Biblioteca Nacional de Medicina) — Mycapssa, Chiesi USA, Inc., vigente desde el 24 de julio 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
6. Nombre en español: RxNorm (Biblioteca Nacional de Medicina de EE. UU.) y Wikidata, vinculados por el identificador RxNorm (RxCUI) del principio activo, sin coincidencias aproximadas.

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