Semaglutide
Regulatory sources consulted
- EMA EPAR EMEA/H/C/004174
- AEMPS CIMA 117251002
- PubMed PMID:40466247 ↗
- PubMed PMID:40865172 ↗
- PubMed PMID:38555109 ↗
- PubMed PMID:37918631 ↗
- AEMPS CIMA · nº registro 117251002 ↗
- EMA EPAR · EMEA/H/C/004174 ↗
- RxNorm rxcui 1991302 ↗
Approved indications
- Treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise: as monotherapy when metformin is considered inappropriate due to intolerance or contraindications; in addition to other medicinal products for the treatment of diabetes.
- Chronic weight management, as an adjunct to a reduced-calorie diet and increased physical activity, in adults with an initial BMI of ≥30 kg/m² (obesity), or ≥27 kg/m² (overweight) in the presence of at least one weight-related comorbid condition.
Contraindications
Absolute
- Hypersensitivity to the active substance or to any of the excipients.
- Personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Clinical warnings
- Boxed warning · Risk of Thyroid C-Cell Tumors. In rodents, semaglutide causes thyroid C-cell tumors. It is unknown whether it causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. Contraindicated in patients with a personal or family history of MTC or MEN 2. — FDA
- Major warning · Acute pancreatitis has been reported. Patients should be informed of the characteristic symptoms (severe, persistent abdominal pain). If pancreatitis is suspected, semaglutide should be discontinued and not restarted if confirmed. — EMA SPC
Drug interactions
- HighInsulin or sulfonylureasA10A, A10BB
Mechanism: Increased risk of hypoglycemia due to the insulinotropic effect of semaglutide.
Recommendation: Consider a dose reduction of the insulin or sulfonylurea to reduce the risk of hypoglycemia when initiating semaglutide treatment.
EMA SPC
- ModerateOral medicationsN/A
Mechanism: Delayed gastric emptying induced by semaglutide, which may alter the rate and/or extent of absorption of oral drugs.
Recommendation: Carefully monitor effects or concentrations of drugs with a narrow therapeutic index (e.g., levothyroxine). Administer oral semaglutide on an empty stomach, 30 minutes before other oral medications.
EMA SPC
Adverse events
Common (≥1%)
nausea · diarrhea · vomiting · constipation · abdominal pain · decreased appetite · fatigue · hypoglycemia
Rare but serious
acute pancreatitis · intestinal obstruction · anaphylactic reaction · acute kidney injury · gastroparesis
Pregnancy and lactation
FDA category: X
Contraindicated during pregnancy and lactation. Treatment should be discontinued at least 2 months before a planned pregnancy due to its long half-life.
Recent literature (PubMed)
Metaanálisis actualizado de 21 ensayos (34,721 pacientes) que concluye que el tratamiento con semaglutida (oral o subcutánea, a dosis bajas o altas) no se asocia con un aumento del riesgo de pancreatitis aguda en comparación con placebo (OR 0.7; 95% CI 0.5-1.2).
Revisión que describe cómo los agonistas de GLP-1, como la semaglutida, actúan sobre múltiples vías fisiopatológicas de la obesidad (regulación del apetito, función adipocitaria, resistencia a la insulina) para lograr una pérdida de peso significativa y mejorar comorbilidades.
Revisión sobre el arsenal terapéutico para la obesidad, destacando que los agonistas del receptor de GLP-1 como la semaglutida logran pérdidas de peso del 15-17%. Menciona la sinergia con otros péptidos (GIP, glucagón) para potenciar los resultados.
Revisión que explora el uso de agonistas de GLP-1 para tratar la obesidad en pacientes con psoriasis e hidradenitis supurativa, sugiriendo que la pérdida de peso inducida puede ser una herramienta útil para manejar estas condiciones dermatológicas inflamatorias.