In a study of adults, GATTEX was proven to help the remaining intestine absorb more fluid.*†
Increased the surface area of the villi in the intestines
The image above is for illustrative purpose only.
Increased absorption of ﬂuid by the intestines by ~750 to 1000 mL/day
The ability of GATTEX to improve the amount of fluid absorbed by the intestines was studied in 17 adults with SBS. Participants in the study received GATTEX for 21 days. All the participants in this study knew they were taking GATTEX. They each took daily doses of either 0.03, 0.10, or 0.15 mg/kg by injection (0.6 to 3 times the recommended dose). The injections were administered under the skin in the stomach area (abdomen). All of the doses studied, except for the 0.03 mg/kg once-daily dose, resulted in enhanced absorption of fluid by the intestines—approximately 750 to 1000 mL per day—and increased the surface area of the intestines.
The ability of GATTEX to improve intestinal absorption in children has not been investigated.
STEPS: This was a 6-month study of 86 adults with SBS who needed PS at least 3 times per week for at least 1 year. Of the 86 participants, 43 received GATTEX and 43 received placebo once a day. The goal was to see if significantly more people treated with GATTEX compared with those who received placebo achieved a reduction in weekly PS volume of at least 20% at Weeks 20 and 24. The study also evaluated safety.
STEPS-2: This was a 24-month study of 88 adults with SBS. Seventy-six people had participated in STEPS (37 received GATTEX, 39 received placebo) and were enrolled in STEPS-2 after STEPS ended. Twelve people had not participated in STEPS and had never been treated with GATTEX before. In STEPS-2, all participants were treated with GATTEX once daily and were told that they were being treated with GATTEX.
Study patients had varying types of intestinal resection, for example, some kept an intact large intestine and/or lower small intestine, some required a stoma, but some did not.
The most common reasons for intestinal resection included vascular disease, Crohn’s disease, or “other.”
(27/43) who were treated with GATTEX reduced their weekly volume of PS by 20% or
30% of people (13/43) who received placebo
(28/30) who completed 30 months of treatment with GATTEX reduced their weekly volume of PS by 20% or more
(21/39) who completed 6 months of treatment with GATTEX achieved at least 1 day off of PS per
23% of people (9/39) who received placebo
(18/30) who completed 30 months of treatment with GATTEX achieved at least 3 days off of PS per week
no longer needed PS
In adult clinical studies, some people experienced improved results the longer they stayed on GATTEX.
For some patients, their doctor was able to reduce weekly PS volume after about 1 month of treatment with GATTEX.
For others, it took 12 months or longer of treatment with GATTEX. Some patients did not respond at all.
Some patients were able to fully wean off of PS after 7 months of treatment with GATTEX.
Some patients required up to 30 months of treatment with GATTEX to fully wean off of PS. Remember, not everyone who takes GATTEX will fully wean off of PS.
STUDY DESIGN: In a 6-month study, 59 children aged 1 through 17 chose whether to receive GATTEX or standard of care (SOC).‡ Children who were treated with GATTEX were subsequently randomized in a double-blind manner to receive either 0.025 mg/kg/day (n=24) or 0.05 mg/kg/day (n=26), while 9 children received SOC. Randomization to the GATTEX groups was stratified by age. All children were dependent on PS prior to the study. The goal was to see if children treated with GATTEX achieved a reduction in weekly PS volume of at least 20% from baseline. The study also evaluated safety.
In this clinical trial, SOC primarily referred to parenteral nutrition, and for many patients, it also included enteral nutrition.
(18/26) who were treated with GATTEX reduced their weekly volume of PS by 20% or more from baseline†
(23 mL/kg/day) in children’s daily PS volume from baseline
of PS per week for 38% of children (10/26) who were treated with GATTEX†
on average, of PS per day for children who were treated with GATTEX‡
(3/26) no longer needed PS
Stomach area (abdomen) pain or swelling
Swelling of the hands or feet
Cold or flu symptoms
Skin reaction where the injection was given
The side effects seen in children and adolescents (aged 1 to 17 years) were similar to those seen in adults. Be sure to talk to your or your child’s doctor about any side effects that are bothersome or that do not go away.
This includes pediatric patients from an additional 3-month study that was conducted with GATTEX.
Track your or your child’s experiences and keep detailed notes that can be used in conversations with the doctor.
Check in with the doctor and talk openly about what you or your child are experiencing.
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What is GATTEX?
GATTEX® (teduglutide) for subcutaneous injection is a prescription medicine used in adults and children 1 year of age and older with Short Bowel Syndrome (SBS) who need additional nutrition or fluids from intravenous (IV) feeding (parenteral support). It is not known if GATTEX is safe and effective in children under 1 year of age.
Important Safety Information
GATTEX may cause serious side effects, including making abnormal cells grow faster, polyps in the colon (large intestine), blockage of the bowel (intestines), swelling (inflammation) or blockage of your gallbladder or pancreas, and fluid overload. Click here for additional Important Safety Information.
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