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Revestive is a brand name for Teduglutide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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.
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 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.
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 8 Frequency System organ class Very common Common Uncommon Not known 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.
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.
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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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.
†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. 9 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 […]
This usually includes the monitoring of small bowel function, gallbladder and bile ducts, and pancreas for 5 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.
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. 6 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’. […]