Teduglutide
Sources réglementaires consultées
Indications approuvées
- Traitement du syndrome de l'intestin court chez les patients à partir de 4 mois d'âge gestationnel corrigé, stables après l'adaptation intestinale postopératoire.
Contre-indications
Absolues
- Hypersensibilité à la substance active, aux excipients ou à des traces de tétracyclines ; malignité active ou suspectée ; antécédent de malignité gastro-intestinale, hépatobiliaire ou pancréatique au cours des cinq dernières années.
Mises en garde cliniques
- Mise en garde majeure · Chez l'adulte, réaliser une coloscopie avec ablation des polypes au début, annuellement pendant les deux premières années puis à des intervalles d'au moins cinq ans ; arrêter en cas de malignité. — AEMPS CIMA, Revestive, ficha técnica 12787001, sección 4.4
- Mise en garde majeure · Surveiller l'obstruction intestinale et les événements biliaires et pancréatiques ; réévaluer la nécessité du traitement en cas de récidive ou d'événement cliniquement pertinent. — AEMPS CIMA, Revestive, ficha técnica 12787001, sección 4.4
- Mise en garde majeure · Ajuster soigneusement le soutien parentéral et surveiller l'équilibre hydrique et électrolytique, notamment au début et à l'arrêt, en raison du risque de surcharge liquidienne ou de déshydratation. — AEMPS CIMA, Revestive, ficha técnica 12787001, sección 4.4
Interactions médicamenteuses
- ModéréeMédicaments oraux concomitants à marge thérapeutique étroite
Mécanisme: L'effet pharmacodynamique du téduglutide peut augmenter l'absorption des médicaments oraux concomitants.
Recommandation: Surveiller les effets indésirables et envisager de réduire la dose d'un médicament concomitant nécessitant une titration ou à marge thérapeutique étroite.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=66b69c1e-b25c-44d3-b5ff-1c1de9a516fa
Effets indésirables
Communs (≥1%)
Douleur abdominale · Distension abdominale · Nausées · Réaction au site d'injection · Céphalée · Vomissements · Infection des voies respiratoires
Rares mais graves
Obstruction intestinale · Pancréatite · Insuffisance cardiaque congestive
Grossesse et allaitement
Par précaution, il est préférable d'éviter l'utilisation pendant la grossesse et l'allaitement.
Bibliographie récente (PubMed)
The term "short bowel syndrome (SBS)" defines "the clinical feature associated with a remaining small bowel in continuity of less than 200 cm from the ligament of Treitz" and is characterized by malabsorption, diarrhea, fatty stools, malnutrition, and dehydration. SBS is the primary pathophysiological mechanism of chronic intestinal failure (CIF), defined as the "reduction of gut function below the minimum necessary for the absorption of macronutrients and/or water and electrolytes, such that intravenous supplementation (IVS) is required to maintain health and/or growth" in a metabolically stable patient. By contrast, the reduction of gut absorptive function that does not require IVS has been termed "intestinal insufficiency or deficiency" (II/ID). The classification of SBS can be categorized as follows: anatomical (anatomy and length of the residual bowel), evolutional (early, rehabilitative, and maintenance phases), pathophysiological (SBS with or without a colon in continuity), clinical (with II/ID or CIF), and severity of CIF (type and volume of the required IVS). Appropriate and homogeneous patient categorization is the mainstay of facilitating communication in clinical practice and in research. Because it is a large protein molecule with a molecular weight of 3752 Da, the amount in milk is likely to be very low. Teduglutide is also poorly absorbed orally so absorption by a breastfed infant is unlikely. Two breastfed infants apparently experienced no adverse effects during maternal use of teduglutide, but no long-term data are available. Until more data are available, teduglutide should be used with careful infant monitoring during breastfeeding.
Short bowel syndrome (SBS) is a malabsorptive condition resulting from reduced functional small intestinal length. SBS is closely related to intestinal failure (IF), defined as the reduction of functional intestinal mass below that which can sustain life, resulting in parenteral nutrition (PN) support for 60 days or greater within a consecutive 74-day period. IF frequently results from intestinal resection necessitated by such diseases as necrotizing enterocolitis in children and Crohn's disease in adults. Clinical manifestations of IF may include diarrhea, growth failure, bacterial overgrowth, and vitamin deficiencies. Nutritional rehabilitation is the cornerstone of IF management. Surgical interventions are aimed at preserving intestinal length and restoring continuity. Medical management involves individualized enteral and parenteral nutrition therapy, GLP-2 agonists (e.g., teduglutide) that promote mucosal growth, and drugs for symptom management such as antidiarrheals. Experimental therapies such as the use of devices to induce intestinal growth through distraction enterogenesis are under development for the treatment of IF. An interdisciplinary approach involving surgeons, gastroenterologists, dietitians, nurses, and social workers is crucial in the management of these complex patients. Ultimately, a combination of nutritional, medical, and surgical management may be necessary to improve clinical outcomes in patients with IF.
Malabsorption is a complex and multifaceted condition characterised by the defective passage of nutrients into the blood and lymphatic streams. Several congenital or acquired disorders may cause either selective or global malabsorption in both children and adults, such as cystic fibrosis, exocrine pancreatic insufficiency (EPI), coeliac disease (CD) and other enteropathies, lactase deficiency, small intestinal bacterial overgrowth (SIBO), autoimmune atrophic gastritis, Crohn's disease, and gastric or small bowel resections. Early recognition of malabsorption is key for tailoring a proper diagnostic work-up for identifying the cause of malabsorption. Patient's medical and pharmacological history are essential for identifying risk factors. Several examinations like endoscopy with small intestinal biopsies, non-invasive functional tests, and radiologic imaging are useful in diagnosing malabsorption. Due to its high prevalence, CD should always be looked for in case of malabsorption with no other obvious explanations and in high-risk individuals. Nutritional support is key in management of patients with malabsorption; different options are available, including oral supplements, enteral or parenteral nutrition. In patients with short bowel syndrome, teduglutide proved effective in reducing the need for parenteral nutrition, thus improving the quality of life of these patients. Primary care physicians have a central role in early detection of malabsorption and should be involved into multidisciplinary teams for improving the overall management of these patients. In this European consensus, involving 10 scientific societies and several experts, we have dissected all the issues around malabsorption, including the definitions and diagnostic testing (Part 1), high-risk categories and special populations, nutritional assessment and management, and primary care perspective (Part 2).
Malabsorption is a complex and multifaceted condition characterised by the defective passage of nutrients into the blood and lymphatic streams. Several congenital or acquired disorders may cause either selective or global malabsorption in both children and adults, such as cystic fibrosis, exocrine pancreatic insufficiency (EPI), coeliac disease (CD) and other enteropathies, lactase deficiency, small intestinal bacterial overgrowth (SIBO), autoimmune atrophic gastritis, Crohn's disease, and gastric or small bowel resections. Early recognition of malabsorption is key for tailoring a proper diagnostic work-up for identifying the cause of malabsorption. A patient's medical and pharmacological history is essential for identifying risk factors. Several examinations such as endoscopy with small intestinal biopsies, non-invasive functional tests and radiological imaging are useful in diagnosing malabsorption. Because of its high prevalence, CD should always be looked for in cases of malabsorption with no other obvious explanations and in high-risk individuals. Nutritional support is key in the management of patients with malabsorption; different options are available, including oral supplements, enteral or parenteral nutrition. In patients with short bowel syndrome, teduglutide proved effective in reducing the need for parenteral nutrition, thus improving the quality of life of these patients. Primary care physicians play a central role in the early detection of malabsorption and should be involved in multidisciplinary teams for improving the overall management of these patients. In this European consensus, involving ten scientific societies and several experts, we have dissected all the issues around malabsorption, including the definitions and diagnostic testing (Part 1), high-risk categories and special populations, nutritional assessment and management, and primary care perspective (Part 2).