For people 1 year of age and older with SHORT BOWEL SYNDROME (SBS) who are dependent on parenteral support (PS)
In a 6-month study, 27/43 adults treated with GATTEX reduced their weekly PS volume by 20% or more vs 13/43 on placebo. 21/39 adults treated with GATTEX achieved at least 1 day off PS per week vs 9/39 with placebo. In a 24-month extension study, 10/30 adults previously on GATTEX no longer needed PS after 30 months of treatment. In a 6-month study of 26 children (aged 1–17) who were treated with GATTEX, 18 reduced their weekly PS volume by 20% or more, 10 achieved a reduction of at least 1 day off PS per week, and 3 no longer needed PS.
GATTEX reduced the weekly volume of parenteral support (PS).
People treated with GATTEX achieved more time off of parenteral support (PS).
Over time, some people achieved complete freedom from parenteral support (PS) with GATTEX.
In a 6-month study, 27 out of 43 adults treated with GATTEX reduced weekly PS volume by 20% or more vs 13 out of 43 on placebo, and 21 out of 39 achieved at least 1 day off PS per week vs 9 out of 39 on placebo. In a 24-month extension study, 10 out of 30 adults previously on GATTEX no longer needed PS after 30 months of treatment. In a 6-month study, 18 out of 26 children treated with GATTEX reduced weekly PS volume by 20% or more, 10 out of 26 achieved a reduction of at least 1 day off PS per week, and 3 out of 26 no longer needed PS.
Examples of how some patients may spend their time with reduced PS requirements are for illustrative purposes only. Be sure to discuss your medical circumstances and activities with your doctor.
SBS is a serious and chronic malabsorption disorder.Learn About SBS
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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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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.