GATTEX works like a natural GLP-2.
In a study of adults, GATTEX was proven to help the remaining intestine absorb more fluid.*†
Increased absorption of ﬂuid by the intestines by ~750 to 1000 mL/day
The image above is for illustrative purpose only.
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 recommended dose is 0.05 mg/kg/day. 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.
Watch this video to gain a better understanding of short bowel syndrome and the GATTEX mechanism of action.
STEPS: This was a 6-month study of 86 adults with short bowel syndrome (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.”
54% (21/39) achieved
23% (9/39) of people who
60% (18/30) achieved
no longer needed PS
In adult clinical studies, some people experienced improved results the longer they stayed on GATTEX.
For some adults, they were 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.
43 patients in STEPS study received GATTEX.
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.
88 patients in STEPS-2 study received GATTEX, including 30 who received GATTEX for 30 months.
||No patients receiving GATTEX during the 6-month STEPS study achieved PS independence
If you experience any side effects, check in with your doctor. Continue taking GATTEX as long as they recommend and work toward the chance of less PS, together.
I knew GATTEX wasn’t a cure,
but something that might help
reduce the volume and number
of days I was infusing PS.
“I knew GATTEX wasn’t a cure, but something that might help reduce the volume and number of days I was infusing PS.”
Track your 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 are experiencing.
Take GATTEX as recommended by your doctor.
Sign up to receive ongoing updates and communications about upcoming events, treatment information, education, resources, and market research opportunities.
Please see our online privacy notice for information about our practices regarding collection, use, and disclosure of information that you may provide us.
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.
Thank you! Please click the button below to download results or see the results here.
SCROLL FOR FULL MEDICATION GUIDE INFORMATION
for injection, for subcutaneous use
Read this Medication Guide carefully before you start taking GATTEX and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
GATTEX may cause serious side effects, including:
Before you start using GATTEX, your healthcare provider will:
To keep using GATTEX, your healthcare provider should:
If cancer is found in a polyp, your healthcare provider should stop GATTEX.
A bowel blockage keeps food, fluids, and gas from moving through the bowels in the normal way. Tell your healthcare provider right away if you have any of these symptoms of a bowel or stomal blockage:
If a blockage is found, your healthcare provider may temporarily stop GATTEX.
Your healthcare provider will do tests to check your gallbladder and pancreas within 6 months before starting GATTEX and at least every 6 months while you are using GATTEX.
Tell your healthcare provider right away if you get:
These are not all the side effects of GATTEX. For more information, see “What are the possible side effects of GATTEX?”
Before using GATTEX, tell your healthcare provider about all your medical conditions, including if you or your child:
Tell your healthcare providers about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using GATTEX with certain other medicines may affect each other causing side effects. Your other healthcare providers may need to change the dose of any oral medicines (medicines taken by mouth) you take while using GATTEX. Tell the healthcare provider who gives you GATTEX if you will be taking a new oral medicine.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
GATTEX may cause serious side effects, including:
The most common side effects of GATTEX in adults include:
The side effects of GATTEX in children and adolescents are similar to those seen in adults.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of GATTEX.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Keep GATTEX and all medicines out of the reach of children.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use GATTEX for a condition for which it was not prescribed. Do not give GATTEX to other people, even if they have the same symptoms that you have. It may harm them.
If you would like more information about GATTEX talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about GATTEX that is written for health professionals.
Active ingredient: teduglutide
Inactive ingredients: dibasic sodium phosphate heptahydrate, L-histidine, mannitol, and monobasic sodium phosphate monohydrate. Sterile Water for Injection is provided as a diluent.