Revestive was well tolerated across multiple clinical trials in adults and children with short bowel syndrome-intestinal failure1


Adverse reactions were retrieved from two placebo-controlled clinical studies.

109 patients with short bowel syndrome-intestinal failure were treated with doses of 0.05 mg/kg/day and 0.10 mg/kg/day (0.10 mg/kg/day is not a recommended dose) for up to 24 weeks.

Approximately 52% of the adults treated with Revestive experienced adverse reactions (vs. 36% of the adults given placebo).

The most common adverse events were:

  • Abdominal pain and distension (45%)
  • Respiratory tract infections (28%)
  • Nausea (26%)
  • Injection site reactions (26%)
  • Headache (16%)
  • Vomiting (14%)

Injection site reactions occurred in 26% of SBS-IF patients treated with Revestive compared with 5% of patients in the placebo arm:

  • The reactions included injection site haematoma, injection site erythema, injection site pain, injection site swelling, and injection site haemorrhage. The majority of reactions were moderate in severity, and no occurrences led to drug discontinuation

Consistent with the potentially immunogenic properties of medicinal products containing peptides, administration of Revestive may potentially trigger the development of antibodies. However, in Phase 3 studies antibody formation was not associated with clinically relevant safety findings, reduced efficacy, or changed pharmacokinetics of Revestive.

No new safety signals were identified in adult patients treated with Revestive 0.05 mg/kg/day for up to 30 months in the long-term STEPS-2 extension study1

Children1, 2

In two completed clinical trials* in children aged 1–17 years-old with short bowel syndrome-intestinal failure treated with Revestive for up to 6 months:

  • No patient discontinued due to adverse events
  • Most treatment-emergent adverse events were mild to moderate in severity
  • The overall safety profile (type and frequency of events) was similar to that reported in adults

No new safety signals seen in long-term pooled paediatric data^ of 89 patients treated with Revestive for 51.7 weeks (median; range 5.0–94.7) and followed up for 83 weeks3

*Revestive was studied in a 12-week, open-label, clinical study in 42 paediatric patients aged 1 year through 14 years with SBS who were dependent on PN/IV. Three (3) doses of Revestive, 0.0125 mg/kg/day (n=8), 0.025 mg/kg/day (n=14), and 0.05 mg/kg/day (n=15), were investigated for 12 weeks.
Five (5) patients were enrolled in an SOC cohort. An additional 24-week, randomised, double-blind, multicentre study was conducted in 59 paediatric patients aged 1 year through 17 years who were dependent on PN/IV. Two (2) doses of Revestive were studied: 0.025 mg/kg/day (n=24) and 0.05 mg/ kg/day (n=26); nine (9) patients were enrolled in an SOC arm.

^Safety data of 89 paediatric patients aged 1-17 years-old treated with REVESTIVE from 4 clinical trials were pooled. Data from the completed 12-week and 24-week clinical trials* and interim data from ongoing open-label extension studies to 12-week and 24-week trials were included. The study objective was to assess the safety of REVESTIVE in children with SBS-IF including when used beyond 24-weeks.


  1. Revestive (teduglutide) Summary of Product Characteristics. Shire Pharmaceuticals Ireland Limited, Dublin, Ireland. November 2017.
  2. Kocoshis SA, Merritt RJ, Hill S, et al. Safety and Efficacy of Teduglutide in Pediatric patients With Intestinal Failure due to Short Bowel Syndrome: A 24-Week, Phase III Study. JPEN J Parenter Enteral Nutr. 2020;44(4):621-631.
  3. Hill S, Carter BA, Cohran V, et al. Safety Findings in Pediatric Patients During Long-Term Treatment With Teduglutide for Short-Bowel Syndrome–Associated Intestinal Failure: Pooled Analysis of 4 Clinical Studies JPEN . J Parenter. Enteral Nutr 2020 E-pub ahead of print

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