Active Ingredient: Teduglutide
Teduglutide 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.
For this indication, competent medicine agencies globally authorize below treatments:
For:
In case that patient age in months is ≥ 4, subcutaneous, 0.05 milligrams teduglutide per kilogram of body weight, once daily.
The recommended dose of Revestive is 0.05 mg/kg body weight once daily. 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. Limited data from clinical studies have shown that some patients may take longer to respond to treatment (i.e., 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.
Treatment should be initiated under the supervision of a medical professional with experience in the treatment of paediatric SBS.
The recommended dose of Revestive in children and adolescents (aged 4 months corrected gestational age to 17 years) is 0.05 mg/kg body weight once daily.
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.
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 should not be administered intravenously or intramuscularly.
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