Teduglutide
Regulatory sources consulted
Approved indications
- Treatment of short bowel syndrome in patients from 4 months corrected gestational age who are stable after post-surgical intestinal adaptation.
Contraindications
Absolute
- Hypersensitivity to the active substance, excipients or traces of tetracyclines; active or suspected malignancy; gastrointestinal, hepatobiliary or pancreatic malignancy within the last five years.
Clinical warnings
- Major warning · In adults, perform colonoscopy with polyp removal at baseline, annually for the first two years and then at intervals of at least five years; discontinue if malignancy occurs. — AEMPS CIMA, Revestive, ficha técnica 12787001, sección 4.4
- Major warning · Monitor intestinal obstruction and biliary and pancreatic events; reassess the need for treatment if they recur or clinically relevant events occur. — AEMPS CIMA, Revestive, ficha técnica 12787001, sección 4.4
- Major warning · Carefully adjust parenteral support and monitor fluid and electrolyte balance, especially at initiation and discontinuation, because of fluid overload or dehydration risk. — AEMPS CIMA, Revestive, ficha técnica 12787001, sección 4.4
Drug interactions
- ModerateConcomitant oral medicines with a narrow therapeutic index
Mechanism: Teduglutide's pharmacodynamic effect may increase absorption of concomitant oral medicines.
Recommendation: Monitor adverse reactions and consider reducing the dose of a concomitant medicine requiring titration or with a narrow therapeutic index.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=66b69c1e-b25c-44d3-b5ff-1c1de9a516fa
Adverse events
Common (≥1%)
Abdominal pain · Abdominal distension · Nausea · Injection-site reaction · Headache · Vomiting · Respiratory tract infection
Rare but serious
Intestinal obstruction · Pancreatitis · Congestive heart failure
Pregnancy and lactation
As a precaution, use during pregnancy and breastfeeding should preferably be avoided.
Recent literature (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).