Teduglutide is an active pharmaceutical ingredient in the Various Alimentary Tract and Metabolism Products group (A16AX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised May 22, 2026[1]
Revestive 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.
How to take
GB
EUEuropean Union· EMA
2 products
Uses
EUOfficial regulatory label· revised May 8, 2026[2]
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.
How to take
EU
CACanada· Health Canada
1 product
How to take
CAOfficial regulatory label· revised September 17, 2025[3]
, Dosing Considerations, Patients with Renal Impairment; 10 CLINICAL PHARMACOLOGY, Pharmacokinetics, Renal Insufficiency). No pediatric patients with renal insufficiency were included in trials. Population pharmacokinetic modelling suggests response in pediatric patients with renal insufficiency would be consistent with that of adults with renal insufficiency.
1 Pregnancy There are no data from the use of REVESTIVE in pregnant women. 05 mg/kg). 05 mg/kg). Because animal reproductive studies are not always predictive of human response, REVESTIVE should be used during pregnancy only if clearly needed.
2 Breastfeeding It is not known whether teduglutide is present in human milk. 05 mg/kg). Because of the potential for serious adverse reactions to nursing infants from REVESTIVE and because of the potential for tumorigenicity shown for teduglutide in mice and rats, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Drug interactions
Known interactions involving Teduglutide. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]MHRA (UK) · PLGB549370015 · revised May 22, 2026
[2]European Medicines Agency · EMEA/H/C/006564 · revised May 8, 2026
[3]Health Canada (DPD) · 02445727 · revised September 17, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
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 a 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. Posology Paediatric population (≥4 months) 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. 25 mg strength vial is provided in Table 1 below. For paediatric patients with a body weight > 20 kg, the 5 mg strength vial should be used. 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. 38 ml >20 kg Use the 5* mg strength vial *For paediatric patients weighing more than 20 kg, the 5 mg strength vial should be used.
Refer to the Summary of Product Characteristics of Revestive 5 mg powder and solvent for solution for injection for dosing information. 05 mg/kg body weight once daily. For adults patients, the 5 mg strength vial should be used. Refer to the Summary of Product Characteristics of Revestive 5 mg powder and solvent for solution for injection for dosing information.
Special populations Renal impairment No dose adjustment is necessary for paediatric patients with mild renal impairment. 2). Hepatic impairment No dose adjustment is necessary for paediatric patients with mild and moderate hepatic impairment based on a study conducted in Child-Pugh grade B adult 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. Revestive should not be administered intravenously or intramuscularly. 6.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised May 22, 2026[1]
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 Injury, poisoning and procedural complications Gastrointestinal stoma complication *Includes the following preferred terms: Nasopharyngitis, Influenza, Upper respiratory tract infection, and Lower respiratory tract infection.
Frequency System organ class Very common Common Uncommon Not known †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 Revestive 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. In phase 3 studies with SBS patients who received teduglutide for ≥ 2 years, 28% of patients developed antibodies against E.
coli protein (residual host cell protein from the manufacture). The antibody formation has not been associated with clinically relevant safety findings, reduced efficacy or changed pharmacokinetics of Revestive. 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.
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 […]
GBOfficial regulatory label· Warnings and precautions· revised May 22, 2026[1]
It is strongly recommended that every time Revestive 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. Adults Colo-rectal polyps A colonoscopy with removal of polyps should be performed at the time of starting treatment with Revestive.
Once yearly follow-up colonoscopies (or alternate imaging) are recommended during the first 2 years of Revestive 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 Revestive 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 Revestive 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. Intestinal obstruction Cases of intestinal obstruction have been reported in clinical studies.
In case of recurrent intestinal obstructions, the need for continued Revestive 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 Revestive.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised May 22, 2026[1]
1, or trace residues of tetracycline. 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.
This is not medical advice. Consult a qualified healthcare professional.
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.
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.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised May 8, 2026[2]
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.
† 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 […]
EUOfficial regulatory label· Warnings and precautions· revised May 8, 2026[2]
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.
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.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised May 8, 2026[2]
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.
This is not medical advice. Consult a qualified healthcare professional.
3 Pediatrics Safety and efficacy in pediatric patients under 1 year of age have not been established. The safety and efficacy of REVESTIVE in the treatment of SBS have been established in pediatric patients 1 through 17 years of age.
Use in this population is supported by adequate and well controlled studies in adults, as well as safety, pharmacokinetic and pharmacodynamic data from 2 studies in pediatric patients up to 24 weeks duration. These studies included 87 pediatric patients treated with REVESTIVE in the following groups: 5 infants (1 year to less than 2 years), 75 children (2 years to less than 12 years) and 7 adolescents (12 years to less than 18 years).
05 mg/kg daily. In these 2 studies and the corresponding open-label extension studies, 89 pediatric patients were administered REVESTIVE prospectively for up to 69 weeks. 0%) patients. Adverse reactions observed in these studies were similar in pediatric patients who received REVESTIVE to those seen in the adult population (see 8 ADVERSE REACTIONS, Clinical Trial Adverse Reactions -Pediatrics).
4 Geriatrics Of the 595 subjects treated with REVESTIVE in clinical studies, 43 subjects were 65 years or older, whereas 6 subjects were 75 years of age or older. No clinically significant differences were observed between subjects younger than 65 years and those older than 65 years.
1 Adverse Reaction Overview Across all clinical studies in adults, 595 subjects were exposed to at least one dose of REVESTIVE (249 patient-years of exposure; mean duration of exposure was 22 weeks). 10 mg/kg/day). 9%). In the core pediatric studies, 87 patients aged 1-17 years were exposed to teduglutide.
05 mg/kg/day. 0% experienced drug-related adverse reactions. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. Therefore, the frequencies of adverse reactions observed in the clinical trials may not reflect frequencies observed in clinical practice and should not be compared to frequencies reported in clinical trials of another drug.
The rates of adverse reactions in adult patients with SBS participating in 2 randomized, placebo controlled, 24-week, double-blind clinical studies (Studies CL0600-020 and CL0600 004) are summarized in Table 4. Only those reactions with a rate of at least 5% in the REVESTIVE group and occurring greater than in the placebo group are summarized.
The majority of these reactions were mild or moderate. 1% (n=49/59) for placebo. Many of these adverse reactions have been reported in association with the underlying disease and/or parenteral nutrition. 05 mg/kg/day (N=77) n (%) Placebo (N=59) n (%) Gastrointestinal Disorders Abdominal Pain 29 (38) 16 (27) Nausea 19 (25) 12 (20) Abdominal […]
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised September 17, 2025[3]
, Clinical Trial Adverse Reactions -Pediatrics). 4 Geriatrics Of the 595 subjects treated with REVESTIVE in clinical studies, 43 subjects were 65 years or older, whereas 6 subjects were 75 years of age or older. No clinically significant differences were observed between subjects younger than 65 years and those older than 65 years.
1 Adverse Reaction Overview Across all clinical studies in adults, 595 subjects were exposed to at least one dose of REVESTIVE (249 patient-years of exposure; mean duration of exposure was 22 weeks). 10 mg/kg/day). 9%). In the core pediatric studies, 87 patients aged 1-17 years were exposed to teduglutide.
05 mg/kg/day. 0% experienced drug-related adverse reactions. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. Therefore, the frequencies of adverse reactions observed in the clinical trials may not reflect frequencies observed in clinical practice and should not be compared to frequencies reported in clinical trials of another drug.
The rates of adverse reactions in adult patients with SBS participating in 2 randomized, placebo controlled, 24-week, double-blind clinical studies (Studies CL0600-020 and CL0600 004) are summarized in Table 4. Only those reactions with a rate of at least 5% in the REVESTIVE group and occurring greater than in the placebo group are summarized.
The majority of these reactions were mild or moderate. 1% (n=49/59) for placebo. Many of these adverse reactions have been reported in association with the underlying disease and/or parenteral nutrition. 05 mg/kg/day of REVESTIVE for up to 42 months in long-term open-label extension studies.
Adverse Reactions of Special Interests Concomitant Oral Medication:
REVESTIVE can increase the absorption of concomitant oral medications such as benzodiazepines and psychotropic agents. 05 mg/kg/day group (on prazepam) experienced dramatic deterioration in mental status progressing to coma during her first week of REVESTIVE therapy.
She was admitted to the Intensive Care Unit where her benzodiazepine level was >300 mcg/L. REVESTIVE and prazepam were discontinued, and the coma resolved 5 days later. In the pediatric clinical studies (up to 69 weeks of exposure), there were no adverse events associated with increased absorption of oral medications.
05 mg/kg/day. 6%), 1 of whom was reported as a serious adverse event and the other as non-serious. The serious case had onset at 6 months, and was REVESTIVE® (teduglutide for injection) Page 16 of 47 possibly associated with previously undiagnosed hypothyroidism and/or cardiac dysfunction.
025 mg/kg/day group. 05 mg/kg/day dose group. No cases were reported in the placebo group. One of these 3 cases had gallbladder perforation and underwent cholecystectomy the next day. The remaining 2 cases underwent elective cholecystectomy at a later date.
In the adult extension studies, 4 subjects had an episode of acute cholecystitis; 4 subjects had new-onset cholelithiasis; and 1 subject experienced cholestasis secondary to an obstructed biliary stent. For pancreatic disease in […]
CAOfficial regulatory label· Warnings and precautions· revised September 17, 2025[3]
, Monitoring and Laboratory Tests) prior to starting treatment with REVESTIVE. 1 Pediatrics Pediatrics (≥1 year of age to <18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of REVESTIVE in pediatric patients has been established; therefore, Health Canada has authorized an indication for pediatric use (see 14 CLINICAL TRIALS).
If no overall improvement is achieved after 6 months, the need for continued treatment should be assessed. 2 Geriatrics Geriatrics (>65 years of age): Evidence from clinical studies and experience suggests that no clinically significant differences in safety and efficacy were observed between subjects younger than 65 years and those older than 65 years.
Experience in subjects 75 years and older is limited. 2 Contraindications REVESTIVE is contraindicated in patients who: • are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING, • have active gastrointestinal (GI) malignancy (GI tract, hepatobiliary, pancreatic), • have a history of malignancies in the gastrointestinal tract and/or the hepatobiliary system including pancreas within the last 5 years.
1 Dosing Considerations Geriatrics (>65 years of age) Evidence from clinical studies and post-marketing experience suggest that no dose adjustment is necessary in patients above the age of 65 years. Patients with Renal Impairment Reduce the dose by 50% in adult patients with moderate and severe renal impairment (creatinine clearance less than 50 mL/min), and end-stage renal disease.
No dose adjustment is necessary for patients with mild renal impairment. No pediatric patients with renal insufficiency were included in trials. Population pharmacokinetic modelling suggests response in pediatric patients with renal insufficiency would be consistent with that of adults with renal insufficiency.
Patients with Hepatic Impairment No dosage adjustment is necessary for patients with mild and moderate hepatic impairment based on a study conducted in Child-Pugh grade B subjects. REVESTIVE has not been studied in subjects with severe hepatic impairment.
This is not medical advice. Consult a qualified healthcare professional.
Electrolyte balance and fluid status should be carefully monitored throughout treatment, especially during initial therapeutic response and discontinuation of Revestive 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 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 Revestive should be reassessed.
Dehydration:
Patients with SBS are susceptible to dehydration that may lead to acute renal failure. In patients receiving Revestive, 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 Revestive. Hepatic impairment Revestive 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 Revestive should be managed carefully. Paediatric population See also general precautions for adults under this section. Colo-rectal polyps/Neoplasia Prior to initiating treatment with Revestive, faecal occult blood testing should be done for all children and adolescents.
Colonoscopy/sigmoidoscopy is required if there is evidence of unexplained blood in the stool. Subsequent faecal occult blood testing should be done annually in children and adolescents while they are receiving Revestive. Colonoscopy/sigmoidoscopy is recommended for all children and adolescents after one year of treatment, every 5 years thereafter while on continuous treatment with Revestive, and if they have new or unexplained gastrointestinal bleeding.
Excipients Revestive contains less than 1 mmol sodium (23 mg) per dose. This means that it is essentially ‘sodium-free’. Caution […]
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 […]
There are no data available from pediatric patients with active, severe, or unstable hepatic impairment. 05 mg/kg body weight administered by subcutaneous injection once daily. Alternation of sites for subcutaneous injection is recommended, and can include the thighs, upper arms, and the abdomen.
REVESTIVE should not be administered intravenously or intramuscularly. REVESTIVE should not be administered to pediatric patients weighing less than 10 kg. 5 mL of preservative-free Sterile Water for Injection provided in the pre-filled syringe.
Allow the vial containing REVESTIVE and water to stand for approximately 30 seconds and then gently roll the vial between your palms for about 15 seconds. Do not shake the vial. Allow the mixed contents to stand for about 2 minutes. Inspect the vial for any undissolved powder.
If undissolved powder is observed, gently roll the vial again until all material is dissolved. Do not shake the vial. The solution should be clear and colorless to light straw colored and free from visible particles. Do not use if the product remains undissolved or is discolored.
REVESTIVE® (teduglutide for injection) Page 6 of 47 Once the drug is completely dissolved, remove the empty syringe and replace with an injection syringe. 02 mL or lower). If two vials are needed, the procedure for the second vial must be repeated and the additional solution withdrawn into the injection syringe containing the solution from the first vial.
Any volume exceeding the prescribed dose in mL must be expelled and discarded. 8 mg teduglutide can be withdrawn) Vials of REVESTIVE and pre-filled syringes of Sterile Water for Injection do not contain any preservatives and are for single-use only.
After reconstitution, the solution should be used immediately. Microbial, chemical and physical stability have been demonstrated for up to 3 hours when stored below 25ºC after reconstitution. Any unused product or waste material should be disposed of in accordance with local requirements.
In the absence of compatibility studies, REVESTIVE should not be mixed with other medicinal products. 4 Administration Each single-use vial of REVESTIVE contains 5 mg of teduglutide as a white lyophilized powder for solution for subcutaneous injection.
5 mL of Sterile Water for Injection, which is provided in a pre-filled syringe. A 10 mg/mL sterile solution is obtained after reconstitution (see Reconstitution below). The prepared solution must be injected subcutaneously into a cleaned area on the abdomen, upper arm, or thigh using a thin needle for subcutaneous injection.
Detailed instructions on the preparation and injection of REVESTIVE are provided in the Patient Medication Information. 05 mg/kg/day. The physician should at each visit weigh the patient, determine the daily dose to be administered until next visit and inform the patient accordingly.