Active Ingredient: Teduglutide
Teduglutide is indicated for the treatment of patients aged 1 year 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:
Subcutaneous
0.05 - 0.05 mg per kg of body weight
From 0.05 To 0.05 mg per kg of body weight once every day
The recommended dose of Revestive is 0.05 mg/kg body weight once daily. The injection volume per body weight is provided in table below. 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.
Continued treatment is recommended for patients who have weaned off parenteral nutrition.
| Body weight | 5 mg strength Volume to be injected |
|---|---|
| 38-41 kg | 0.20 ml |
| 42-45 kg | 0.22 ml |
| 46-49 kg | 0.24 ml |
| 50-53 kg | 0.26 ml |
| 54-57 kg | 0.28 ml |
| 58-61 kg | 0.30 ml |
| 62-65 kg | 0.32 ml |
| 66-69 kg | 0.34 ml |
| 70-73 kg | 0.36 ml |
| 74-77 kg | 0.38 ml |
| 78-81 kg | 0.40 ml |
| 82-85 kg | 0.42 ml |
| 86-89 kg | 0.44 ml |
| 90-93 kg | 0.46 ml |
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 1 to 17 years) is the same as for adults (0.05 mg/kg body weight once daily). The injection volume per body weight when using the 5 mg strength vial is provided in table below. A 1.25 mg strength vial 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. There are no data available in paediatric patients after 6 months.
| Body weight | 5 mg strength Volume to be injected |
|---|---|
| 10-11 kg | 0.05 ml |
| 12-13 kg | 0.06 ml |
| 14-17 kg | 0.08 ml |
| 18-21 kg | 0.10 ml |
| 22-25 kg | 0.12 ml |
| 26-29 kg | 0.14 ml |
| 30-33 kg | 0.16 ml |
| 34-37 kg | 0.18 ml |
| 38-41 kg | 0.20 ml |
| 42-45 kg | 0.22 ml |
| 46-49 kg | 0.24 ml |
| ≥50 kg | See table under “Adults” section |
The reconstituted solution should be administered by subcutaneous injection once daily, alternating sites between 1 of the 4 quadrants of the abdomen.
Liability Disclaimer : RxReasoner has utilized reasonable care in providing content and services that are accurate, complete and up to date. However, RxReasoner does not accept any responsibility or liability about it. The content and services of RxReasoner are for informational purposes only and they are not intended to be a substitute for the knowledge, expertise, skill, and judgment of physicians, pharmacists, nurses, or other healthcare professionals involved in patient care. RxReasoner offers no medical advice. Users are responsible for the use of the provided content. A shown indication or treatment should not be construed to indicate that the medication is safe, appropriate, or effective in any given patient or under any particular circumstances. The absence of an indication or treatment should not roule out the existence of other appropriate medications. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition or medicament. RxReasoner is not liable for any damages allegedly sustained arising out of the use of its content and services.
