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.
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.
People treated with
GATTEX 0.05 mg/kg/day
|Primary causes of SBS|
|Mean remaining small intestine length||47%|
|Mean PS infusion volumes||60 mL/kg/day|
|Mean PS infusion time||7 days/week|
reduced their weekly
volume of PS by 20% or
(-23/mL/kg/day) in daily
PS volume from baseline
38% (10/26) achieved
¶ Results are presented for the 0.05 mg/kg/day dosage, which is the recommended dosage of GATTEX.
# 7 days/week average baseline PS requirement for GATTEX 0.05 mg/kg/day dosage group.
** 11 hours/day average baseline PS requirement for GATTEX 0.05 mg/kg/day dosage group.
(3/26) no longer needed PS
Work with your child's doctor to understand treatment expectations and check with them if your child is experiencing any side effects. Have your child continue taking GATTEX as long as their doctor recommends.
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.
I had no expectations...
but we kept going...
Penelope’s now free from PS
mother of Penelope,
After 6 months of treatment, 3 out of 26 children treated
with GATTEX no longer needed PS.
Individual results may vary.
“I had no expectations... but we kept going... Penelope’s now free from PS”
MOTHER OF PENELOPE, GATTEX PATIENT
After 6 months of treatment, 3 out of 26 children treated with GATTEX no longer needed PS.
Individual results may vary
Track 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 your child is experiencing.
Take GATTEX as recommended by your child's doctor.
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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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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.