Teduglutide

(Gattex®)

Teduglutide

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Drug updated on 4/17/2024

Dosage FormInjection (subcutaneous; 5 mg)
Drug ClassGlucagon-like peptide 2 (GLP-2) analogs
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adults and pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who are dependent on parenteral support.

Summary
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  • Teduglutide (Gattex) is indicated for the treatment of adults and pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who are dependent on parenteral support. It has shown significant potential in reducing dependency on parental support across both adult and pediatric populations.
  • The information was derived from seven systematic reviews/meta-analyses studies, providing a comprehensive comparison of teduglutide to other treatments for SBS based on safety and effectiveness.
  • Studies showed that a significant percentage of patients achieved a 20% reduction in parenteral support at various time intervals with teduglutide use. The presence of the colon notably influenced response rates but was associated with higher weaning rates.
  • Gastrointestinal issues were the most common adverse events reported among users, including nonpathological pancreatic enzyme elevation. However, these occurred at comparable rates between teduglutide users and placebo recipients.
  • Long-term safety concerns have been raised about teduglutide's usage due to gastrointestinal adverse events and pancreatic enzyme elevations; further investigations are needed despite recent studies supporting its ongoing use.
  • Specific population considerations include children with SBS where it demonstrated benefits by reducing parenteral nutrition requirements while improving enteral autonomy. Also noteworthy is an important subgroup consideration: those having their colon in continuity with the small intestine show adjusted response rates when treated using Teduglutide therapy.

Product Monograph / Prescribing Information

Document TitleYearSource
Gattex (teduglutide) Prescribing Information.2022Takeda Pharmaceuticals, USA

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines