Please consult the Summary of Product Characteristics (SmPC), before prescribing.
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.
Hypersensitivity to the active substance or to any of the excipients, 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.
Colo-rectal polyps
A colonoscopy with removal of polyps should be performed at the time of starting treatment. Yearly follow-up colonoscopies are recommended during the first 2 years. Subsequent colonoscopies are recommended at a minimum of five year intervals. An individual assessment whether increased frequency of surveillance is necessary should be performed based on the patient. If a polyp is found, adherence to current polyp follow-up guidelines is recommended. In case of malignancy, therapy must be discontinued.
Colo-rectal polyps/Neoplasia (Paediatric population)
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.
Gastrointestinal neoplasia including hepatobiliary tract
In the rat carcinogenicity study, benign tumours were found in the small bowel and the extrahepatic bile ducts. These observations were not confirmed in clinical studies of more than one year duration. If a neoplasia is detected, it should be removed. In case of malignancy, Revestive treatment should be discontinued.
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 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 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 includes monitoring of short 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 have been reported in clinical studies. In case of recurrent intestinal obstructions, the need for continued treatment should be reassessed.
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. 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 contact their physician in case of sudden weight gain, swollen ankles and/or dyspnoea. Fluid overload can be prevented by appropriate and timely assessment of parenteral nutrition needs. 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.
Management of fluids during treatment
Parenteral support should be reduced carefully and should not be discontinued abruptly. The fluid status should be evaluated following parenteral support reduction and adjusted as needed.
Concomitant medication
Patients receiving oral concomitant medicinal products requiring titration or with a narrow therapeutic index should be monitored closely due to potential increased absorption.
Special clinical conditions
Caution should be exercised when prescribing in patients with severe, clinically unstable concomitant diseases or with malignancies within the last five years.
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 should be managed carefully.
Excipients
Revestive contains less than 1 mmol sodium (23 mg) per dose. This means that it is essentially ‘sodium-free’. Caution is needed when administering Revestive to persons with a known hypersensitivity to tetracycline.
| Very common (frequency ≥1/10) | Respiratory tract infection*, headache, abdominal pain and distension, nausea, vomiting, injection site reaction‡, gastrointestinal stoma complication. |
| Very common (frequency ≥1/10) | Influenza-like illness, decreased appetite, fluid overload, anxiety, insomnia, congestive heart failure, cough, dyspnoea, colorectal polyp, colonic stenosis, flatulence, intestinal obstruction, pancreatic duct stenosis, pancreatitis†, small intestinal stenosis, cholecystitis, cholecystitis acute, oedema peripheral. |
| Uncommon (≥1/1,000 to <1/100) | Syncope, duodenal polyp |
* 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.
‡ Includes the following preferred terms: Injection site haematoma, Injection site erythema, Injection site pain, Injection site swelling and Injection site haemorrhage.
pi-00651
Date of preparation: February 2019