atic impairment.
Paediatric population: Revestive should not be used in children below 18 years old because of safety concerns.
Contraindications
Hypersensitivity to the active substance, excipients, or tetracycline. Active or suspected malignancy or a history of malignancies in the gastrointestinal tract or hepatobiliary system within the last five years.
Special Warnings and Precautions for Use
Intestinotrophic Effects
Colo-rectal polyps: A colonoscopy with removal of polyps should be performed at the time of starting treatment and at a minimum of five year intervals with an individual assessment regarding frequency of surveillance based on the patient characteristics. If a polyp is found, adherence to current polyp follow-up guidelines is recommended. In case of malignancy, Revestive therapy should be discontinued.
Gastrointestinal neoplasia including hepatobiliary tract: If a neoplasia is detected, it should be removed. In case of malignancy, Revestive therapy should be discontinued.
Gallbladder and bile ducts: In case of gallbladder or bile duct-related symptoms, the need for continued Revestive treatment should be reassessed.
Pancreatic diseases: In case of pancreatic adverse events, the need for continued Revestive treatment should be reassessed.
Intestinal obstruction: In case of recurrent intestinal obstructions, the need for continued Revestive treatment should be reassessed.
Increased Absorption
Cardiovascular: Due to increased fluid absorption, patients with cardiovascular disease should be monitored with regard to fluid overload, especially during initiation of therapy. In case of a significant deterioration of the cardiovascular disease, the need for continued Revestive treatment should be reassessed.
Concomitant treatment: Patients receiving oral concomitant medicinal products requiring titration or with a narrow therapeutic index should be monitored closely due to potential increased absorption. Discontinuation of treatment: Due to the risk of dehydration, discontinuation of treatment with Revestive should be managed carefully.
Monitoring and Concomitant Diseases
Monitoring of small bowel, gallbladder and bile ducts, and pancreas: SBS patients are to be kept under close surveillance. This usually includes the monitoring of short bowel function, gallbladder and bile ducts, and pancreas for signs and symptoms. Revestive Safety Information: Version: 001-0122014
Special clinical conditions: Revestive has not been studied in patients with severe, clinically unstable concomitant diseases or in patients with malignancies within the last five years. 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.
Excipients: Revestive contains less than 1mmol sodium (23 mg) per does. This means that it is essentially “sodium-free”. Caution is needed when administering Revestive to persons with a known hypersensitivity to tetracycline.
Fertility, pregnancy and lactation
There are no data from the use of Revestive in pregnant women. It is unknown whether teduglutide is excreted in human milk. There are no data on the effects of teduglutide on human fertility. As a precautionary measure, it is preferable to avoid the use of Revestive during pregnancy and breastfeeding.
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