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Teduglutide Viatris is a brand name for Teduglutide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Teduglutide Viatris is indicated for the treatment of patients 4 months corrected gestational age and above with Short Bowel Syndrome (SBS). Patients should be stable following a period of intestinal adaptation after surgery.
Verbatim from this product's EMA label. Tap a section to expand.
Treatment should be initiated under the supervision of a medical professional with experience in the treatment of SBS. Treatment should not be initiated until it is reasonable to assume that the patient is stable following a period of intestinal adaptation.
Optimisation and stabilisation of intravenous fluid and nutrition support should be performed before initiation of treatment. Clinical assessment by the physician should consider individual treatment objectives and patient preferences.
Treatment should be stopped if no overall improvement of the patient condition is achieved. Efficacy and safety in all patients should be closely monitored on an ongoing basis according to clinical treatment guidelines. 05 mg/kg body weight once daily.
The injection volume per body weight is provided below in Table 1. Due to the heterogeneity of the SBS population, a carefully monitored down-titration of the daily dose may be considered for some patients to optimise tolerability of the treatment.
If a dose is missed, that dose should be injected as soon as possible on that day. Treatment effect should be evaluated after 6 months. , those who still have presence of colon-in-continuity or distal/terminal ileum); if no overall improvement is achieved after 12 months, the need for continued treatment should be reconsidered.
3 Continued treatment is recommended for patients who have weaned off parenteral nutrition. 46 ml Paediatric population (≥ 1 year) Treatment should be initiated under the supervision of a medical professional with experience in the treatment of paediatric SBS.
05 mg/kg body weight once daily). The injection volume per body weight when using the 5 mg strength vial is provided in Table 2 below. 25 mg strength vials is also available for paediatric use (patients with a body weight < 20 kg). If a dose is missed, that dose should be injected as soon as possible on that day.
A treatment period of 6 months is recommended after which treatment effect should be evaluated. In children below the age of two years, treatment should be evaluated after 12 weeks. 1). 24 ml ≥50 kg See Table 1 under “Adults” section.
25 mg vials should be used. Other medicinal products with the active substance teduglutide are available for administration to paediatric patients aged 4 months to less than 12 months. Special populations Elderly No dose adjustment is necessary in patients above the age of 65 years.
10 mg/kg/day for up to 24 weeks. Approximately 52% of the patients treated with teduglutide experienced adverse reactions (versus 36% of the patients given placebo). The most commonly reported adverse reactions were abdominal pain and distension (45%), respiratory tract infections (28%) (including nasopharyngitis, influenza, upper respiratory tract infection, and lower respiratory tract infection), nausea (26%), injection site reactions (26%), headache (16%), and vomiting (14%).
Approximately 38% of the treated patients with a stoma experienced gastrointestinal stoma complications. The majority of these reactions were mild or moderate. 05 mg/kg/day of teduglutide for up to 30 months in a long-term open-label extension study.
Tabulated list of adverse reactions Adverse reactions are listed below by MedDRA system organ class and by frequency. Frequencies are defined as very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000); not known (cannot be estimated from available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. All adverse reactions identified in post-marketing experience are italicised. Frequency System organ class Very common Common Uncommon Not known Infections and infestations Respiratory tract infection* Influenza-like illness Immune system disorders Hypersensitivity Metabolism and nutrition disorders Decreased appetite, Fluid overload Psychiatric disorders Anxiety, Insomnia Nervous system disorders Headache Cardiac disorders Congestive heart, failure Vascular disorders Syncope Respiratory, thoracic and mediastinal disorders Cough, Dyspnoea Gastrointestinal disorders Abdominal distension, Abdominal pain, Nausea, Vomiting Colorectal polyp, Colonic stenosis, Flatulence, Intestinal obstruction, Pancreatic duct stenosis, Pancreatitis†, Small intestinal stenosis Small intestinal polyp‡ Gastric polyp Hepatobiliary disorders Cholecystitis, Cholecystitis acute General disorders and administration site conditions Injection site reaction§ Oedema peripheral Fluid retention 9 Frequency System organ class Very common Common Uncommon Not known Injury, poisoning and procedural complications Gastrointestinal stoma complication * Includes the following preferred terms: Nasopharyngitis, Influenza, Upper respiratory tract infection, and Lower respiratory tract infection.
It is strongly recommended that every time Teduglutide Viatris is administered to a patient, the name and lot number of the product are recorded in order to maintain a link between the patient and the lot of the product. 5 Adults Colo-rectal polyps A colonoscopy with removal of polyps should be performed at the time of starting treatment with teduglutide.
Once yearly follow-up colonoscopies (or alternate imaging) are recommended during the first 2 years of teduglutide treatment. Subsequent colonoscopies are recommended at a minimum of five-year intervals. , age, underlying disease). 1.
If a polyp is found, adherence to current polyp follow-up guidelines is recommended. 3). Gastrointestinal neoplasia including hepatobiliary tract In the rat carcinogenicity study, benign tumours were found in the small bowel and the extrahepatic bile ducts.
Development of small intestinal polyps has also been observed in human SBS patients within several months after start of teduglutide treatment. Because of this, upper gastro-intestinal endoscopy or other imaging is recommended before and during the treatment with teduglutide.
If a neoplasia is detected, it should be removed. 3). Gallbladder and bile ducts Cases of cholecystitis, cholangitis, and cholelithiasis have been reported in clinical studies. In case of gallbladder or bile duct-related symptoms, the need for continued teduglutide treatment should be reassessed.
Pancreatic diseases Pancreatic adverse events such as chronic and acute pancreatitis, pancreatic duct stenosis, pancreas infection and increased blood amylase and lipase have been reported in clinical studies. In case of pancreatic adverse events, the need for continued teduglutide treatment should be reassessed.
Monitoring of small bowel, gallbladder and bile ducts, and pancreas SBS patients are to be kept under close surveillance according to clinical treatment guidelines. This usually includes the monitoring of small bowel function, gallbladder and bile ducts, and pancreas for signs and symptoms, and, if indicated, additional laboratory investigations and appropriate imaging techniques.
1. Active or suspected malignancy. Patients with a history of malignancies in the gastrointestinal tract, including the hepatobiliary system and pancreas within the last five years.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Renal impairment No dose adjustment is necessary for adult or paediatric patients with mild renal impairment. 2). Hepatic impairment No dose adjustment is necessary for patients with mild and moderate hepatic impairment based on a study conducted in Child-Pugh grade B subjects.
2). Paediatric population (< 4 months) There are currently no available data in children below 4 months corrected gestational age. Method of administration The reconstituted solution should be administered by subcutaneous injection once daily, alternating sites between 1 of the 4 quadrants of the abdomen.
In case the injection into the abdomen is hampered by pain, scarring or hardening of the tissue, the thigh can also be used. Teduglutide Viatris should not be administered intravenously or intramuscularly. 6.
† Includes the following preferred terms: Pancreatitis, Pancreatitis acute, and Pancreatitis chronic. ‡ Locations include duodenum, jejunum, and ileum. § Includes the following preferred terms: Injection site haematoma, Injection site erythema, Injection site pain, Injection site swelling and Injection site haemorrhage.
Description of selected adverse reactions Immunogenicity Consistent with the potentially immunogenic properties of medicinal products containing peptides, administration of teduglutide may potentially trigger the development of antibodies.
05 mg/kg teduglutide once daily was 3% (2/60) at Month 3, 17% (13/77) at Month 6, 24% (16/67) at Month 12, 33% (11/33) at Month 24, and 48% (14/29) at Month 30. The antibody formation has not been associated with clinically relevant safety findings, reduced efficacy or changed pharmacokinetics of teduglutide.
Injection site reactions Injection site reactions occurred in 26% of SBS patients treated with teduglutide, compared to 5% of patients in the placebo arm. 3). The majority of reactions were moderate in severity and no occurrences led to drug discontinuation.
C-reactive protein Modest increases of C-reactive protein of approximately 25 mg/l have been observed within the first seven days of teduglutide treatment, which decreased continuously under ongoing daily injections. 5 mg/l on average.
These changes were neither associated with any changes in other laboratory parameters nor with any reported clinical symptoms. There were no clinically relevant mean increases of C-reactive protein from baseline following long-term treatment with teduglutide for up to 30 months.
Paediatric population In two completed clinical trials, there were 87 paediatric subjects (aged 1 to 17 years) enrolled and exposed to teduglutide for a duration of up to 6 months. No subject discontinued the studies due to an adverse event.
Overall, the safety profile of teduglutide (including type and frequency of adverse reactions, and immunogenicity) in children and adolescents (ages 1-17 years) was similar to that in adults. In three completed clinical studies in paediatric subjects (aged 4 to < 12 months corrected gestational age), the safety profile reported in these studies was consistent with the safety profile seen in the previous paediatric studies and no new safety issues were identified.
10 Limited long-term safety data is available for the paediatric population. No data are available for children under 4 months of age. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are […]
Intestinal obstruction Cases of intestinal obstruction have been reported in clinical studies. In case of recurrent intestinal obstructions, the need for continued teduglutide treatment should be reassessed. Fluid overload and electrolyte balance To avoid fluid overload or dehydration, careful adjustment of parenteral support is required in patients taking teduglutide.
Electrolyte balance and fluid status should be carefully monitored throughout treatment, especially during initial therapeutic response and discontinuation of teduglutide treatment. Fluid overload Fluid overload has been observed in clinical trials.
Fluid overload adverse events occurred most frequently during the first 4 weeks of therapy and decreased over time. Due to increased fluid absorption, patients with cardiovascular disease, such as cardiac insufficiency and hypertension, should be monitored with regard to fluid overload, especially during initiation of 6 therapy.
Patients should be advised to contact their physician in case of sudden weight gain, face swelling, swollen ankles and/or dyspnoea. In general, fluid overload can be prevented by appropriate and timely assessment of parenteral nutrition needs.
This assessment should be conducted more frequently within the first months of treatment. Congestive heart failure has been observed in clinical trials. In case of a significant deterioration of the cardiovascular disease, the need for continued treatment with teduglutide should be reassessed.
Dehydration Patients with SBS are susceptible to dehydration that may lead to acute renal failure. In patients receiving teduglutide, parenteral support should be reduced carefully and should not be discontinued abruptly. The patient’s fluid status should be evaluated following parenteral support reduction and corresponding adjustment performed, as needed.
5). 3). Caution should be exercised when prescribing teduglutide. Hepatic impairment Teduglutide has not been studied in patients with severe hepatic impairment. The data from use in subjects with moderate hepatic impairment do not suggest a need for restricted use.
Discontinuation of treatment Due to the risk of dehydration, discontinuation of treatment with teduglutide should be managed carefully. Hypersensitivity to tetracycline when changing teduglutide medicinal products Teduglutide Viatris is produced synthetically.
coli using recombinant DNA technology exists, and that product is contraindicated in patients with hypersensitivity to tetracycline. Patients with known hypersensitivity to tetracycline should be informed on the eventual contraindications for the alternative teduglutide medicinal product, if planning to change from Teduglutide Viatris.
Paediatric population See also general precautions for adults under this section. Colo-rectal polyps/Neoplasia Prior to initiating treatment with teduglutide, faecal occult blood testing should be done for all children and adolescents.
Colonoscopy/sigmoidoscopy is […]