I’m strong.
I’m determined.

I’m Gutsy.

I know how much courage it takes to live with Short Bowel Syndrome (SBS) and manage it each day. That’s why they call me GUTSY. I can help you and your child get to know GATTEX®—a treatment for children 1 year and older with SBS.

See what may be possible with GATTEX

GATTEX is a prescription medicine for children and adolescents aged 1 to 17 years with Short Bowel Syndrome (SBS) who require additional nutrition or fluids from intravenous (IV) feeding. This is also known as parenteral support (PS).

GATTEX works like natural GLP-2

GATTEX is the first and only medicine that works like the glucagon-like peptide-2 (GLP-2) the body normally makes on its own. In a study in adults, GATTEX was shown to improve the amount of fluids absorbed by the intestines.*

*The ability of GATTEX to improve intestinal absorption in children has not been investigated.

Ready to learn more? Let’s go!

GATTEX may reduce the need for PS

In a 24-week study, 59 pediatric patients aged 1 through 17 years chose whether to receive GATTEX or standard of care (SOC). Patients who chose to receive GATTEX treatment were subsequently randomized in a double-blind manner to 0.025 mg/kg/day (n=24) or 0.05 mg/kg/day (n=26), while 9 patients enrolled in the SOC arm. Randomization to the GATTEX dose group was stratified by age. All patients had been unable to reduce their dependence on PS for at least 3 months prior to the study. The recommended dose of GATTEX is 0.05 mg/kg/day.

Many children REDUCED PS with GATTEX at 24 weeks*

69%

18 of 26 patients reduced weekly PS volume by 20% or more from baseline

Baseline mean PS volume was 60 mL/kg/day.

Children required LESS PS over time with GATTEX at 24 weeks*

42%

Less PS volume on average from baseline

23 mL/kg/day mean volume reduction.

*Results are presented for the 0.05 mg/kg/day dose, which is the recommended dose of GATTEX.

Time off from PS may be possible with GATTEX

Children treated with GATTEX REDUCED HOURS PER DAY on PS at 24 weeks*

3

Fewer hours/day on PS on average From baseline

11 hours/day mean baseline PS requirement for GATTEX study population.

Children treated with GATTEX REDUCED DAYS PER WEEK on PS at 24 weeks*

38%

10 of 26 patients reduced PS by 1 day/​week or more from baseline

7 days/week mean baseline PS requirement for GATTEX study population.

Some children achieved FREEDOM from PS with GATTEX*

3 of 26

12% of patients fully weaned off PS by week 24

*Results are presented for the 0.05 mg/kg/day dose, which is the recommended dose of GATTEX.

The safety of GATTEX has been studied in 41 pediatric patients aged 1 to 17 years with SBS across 2 clinical studies*

The side effects seen in children and adolescents were generally similar to those seen in adults. See the Important Safety Information below, and be sure to talk to your child’s healthcare provider about any side effects that your child may experience while on GATTEX.

*This includes pediatric patients from an additional 12-week study that was conducted with GATTEX.

Every person with SBS is unique and responds differently to treatment.

Learn how to properly administer GATTEX

Once your child is ready to begin treatment with GATTEX, be sure to follow the training provided by your healthcare provider. It’s important to remember:

  • GATTEX must be administered by an adult. Self-administration by children or adolescents is not recommended
  • If you choose, a OnePath® Nurse Educator will schedule an in-home injection training visit to help you prepare, mix, and administer GATTEX. A OnePath nurse is available 24/7 by phone to help you with any questions about mixing, administering, or storing GATTEX

Instructions for Use (IFU)

Get step-by-step instructions for injecting GATTEX. You should read the IFU before you start administering GATTEX and each time your child gets a refill.

I’d love one

How should I inject GATTEX?

  • The recommended dosage of GATTEX for both adults and pediatric patients is 0.05 mg/kg once daily by subcutaneous injection
  • Use of the GATTEX 5 mg kit is not recommended in children weighing less than 22 pounds (10 kg)
  • Inject the dose of GATTEX under the skin (subcutaneous injection) in the stomach area (abdomen), upper legs (thighs), or upper arms. Do not inject GATTEX into a vein or muscle
  • Use a different injection site each time you administer GATTEX
  • If a dose is missed, that dose should be administered as soon as possible on that day. Do not administer 2 doses on the same day
  • Read the GATTEX Medication Guide and IFU for complete information about how to administer GATTEX, and discuss any questions with your child’s healthcare provider

How should I store GATTEX?

  • Store GATTEX powder at room temperature up to 77°F (25°C)
  • Do not freeze GATTEX
  • Use the GATTEX powder by the expiration date on the “Use By” sticker on the kit
  • Use GATTEX within 3 hours after mixing it
  • Throw away any unused GATTEX that has been mixed, even if there is medicine left in the vial
  • Do not store any GATTEX you have mixed
Keep GATTEX and all medicines out of the reach of children.

You don’t have to face SBS alone.
Learn more about support with OnePath.

What is GATTEX?

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 the gallbladder or pancreas, and fluid overload. Click Tap here for additional Important Safety Information.

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.

Click Tap here for additional Important Safety Information.

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

What is the most important information I should know about GATTEX?

GATTEX may cause serious side effects, including:

Making abnormal cells grow faster

GATTEX can make abnormal cells that are already in the body grow faster. There is an increased risk that abnormal cells could become cancer. If your child gets cancer of the bowel (intestines), liver, gallbladder or pancreas while using GATTEX, the healthcare provider should stop GATTEX. If your child gets other types of cancers, you and the healthcare provider should discuss the risks and benefits of using GATTEX.

Polyps in the colon (large intestine)

Polyps are growths on the inside of the colon. The healthcare provider will check for blood in the stool before your child starts using GATTEX.

To keep using GATTEX, the healthcare provider should have your child’s colon checked for new polyps at the end of 1 year of using GATTEX. If no polyp is found, the healthcare provider should check for polyps as needed and at least every 5 years and have any new polyps removed. If cancer is found in a polyp, the healthcare provider should stop GATTEX.

Blockage of the bowel (intestines)

A bowel blockage keeps food, fluids, and gas from moving through the bowels in the normal way. Tell the healthcare provider right away if your child has any of these symptoms of a bowel or stomal blockage:

If a blockage is found, the healthcare provider may temporarily stop GATTEX.

Swelling (inflammation) or blockage of the gallbladder or pancreas

The healthcare provider will do tests to check your child’s gallbladder and pancreas within 6 months before starting GATTEX and at least every 6 months while your child is using GATTEX. Tell the healthcare provider right away if your child gets:

Fluid overload

The healthcare provider will check your child for too much fluid in the body. Too much fluid in the body may lead to heart failure, especially if your child has heart problems. Tell the healthcare provider if your child gets swelling in the feet and ankles, your child gains weight very quickly (water weight), or your child has trouble breathing.

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 the healthcare provider if your child has any side effect that bothers you or your child or that does not go away.

What should I tell the healthcare provider before my child uses GATTEX?

Tell the healthcare provider about all your child’s medical conditions, including if your child:

Tell the healthcare providers about all the medicines your child takes, including prescription or over-the-counter medicines, vitamins, and herbal supplements. Using GATTEX with certain other medicines may affect each other causing side effects. Other healthcare providers may need to change the dose of any oral medicines (medicines taken by mouth) your child takes while using GATTEX. Tell the healthcare provider who gives your child GATTEX if your child will be taking a new oral medicine.

Call the doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For additional safety information, click here for full Prescribing Information and Medication Guide, and discuss any questions with your child’s doctor.