Gattex® (U.S.)/ Revestive® (EU) (teduglutide [rDNA origin] for injection) is a novel, recombinant analog of human glucagon-like peptide 2, a protein involved in the rehabilitation of the intestinal lining. Gattex® is indicated for the treatment of adult patients with short bowel syndrome (SBS) who are dependent on parenteral support. Significant reductions in mean PN/IV infusion volume from baseline to end of treatment were seen in the Phase 3 studies of Gattex. In addition, some patients were able to achieve independence from PN/IV support during these trials. The most common side effects of Gattex include stomach area (abdomen) pain or swelling, skin reaction where the injection was given, nausea, headache, cold or flu like symptoms, vomiting, and holding too much fluid in the body (swelling of face, ankles, hands or feet).
The European Commission granted European market authorization on August 30, 2012 for the medicinal product teduglutide (trade name in Europe: Revestive®) as a once-daily treatment for adult patients with short bowel syndrome. In March 2013, NPS reacquired the rights to teduglutide outside the United States, Canada, Mexico and Israel from Takeda GmbH.
Important Safety Information (ISI)
Gattex has been associated with serious risks including:
Prescribers should select the appropriate patients to receive Gattex in accordance with the approved prescribing information, discuss the benefits and risks of Gattex with patients, and monitor patients as specified in the approved prescribing information and report adverse events to NPS’ Gattex information line at
or event/product complaint line at