How GATTEX Works

GATTEX is an FDA-approved analog of naturally occurring GLP-21

Watch the video below to learn more about the mechanism of action of GATTEX.

Video Transcript

Narrator: When living with short bowel syndrome, or SBS, maintaining proper nutrition and hydration can be complicated. Understanding how a healthy bowel works may help explain how nutritional needs change after parts of the intestine are removed, as is often the case for people with SBS. Let's take a look.

After eating, the stomach starts to break up food. Then, as food moves into the small intestine, a majority of the nutrients, such as fats, vitamins, and minerals are absorbed, while the large intestine absorbs mostly water and electrolytes. As the stomach starts to digest food, nerves are stimulated to send signals to the far end of the lower intestine and part of the large intestine that nutrients are on the way.

The signals are sent to L-cells which trigger the release of hormones to aid in digestion. GLP-2, or glucagon-like peptide 2, is one of the hormones released. It plays a key role in helping the intestines absorb nutrients in a variety of ways. GLP-2 increases the height and depth of finger-like structures in the intestine known as villi. Since nutrients are absorbed through the villi, the greater height and depth increases intestinal surface area so more nutrients can be absorbed. Additionally, GLP-2 reduces gastric acid secretions, slows the movement of food, allowing more time for nutrients to be absorbed, and increases intestinal blood flow.

When someone has SBS, parts of the intestine have been surgically removed, and the remaining intestine may not be able to absorb enough nutrients from food or drink. Surgery may also remove portions of the intestines that include the L-cells that produce GLP-2.

Because of the malabsorption associated with SBS, some people are dependent on parenteral support, which ranges from IV hydration to total parenteral nutrition, to get the nutrients they are no longer able to absorb through the remaining intestines.

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.

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

GATTEX may cause serious side effects including making abnormal cells grow faster, polyps in the intestines, blockage of the bowel (intestines), swelling (inflammation) or blockage of your gallbladder or pancreas, and fluid overload.

The full Important Safety Information for GATTEX is available at the end of this video.

When GATTEX (teduglutide) is injected into the body, it moves through the bloodstream until it reaches the intestinal cells in the digestive tract. GATTEX is structurally similar to the GLP-2 the body would naturally make on its own. In fact, the only difference from GLP-2 is a single amino acid, which slows the breakdown of GATTEX.

About half of the body's own GLP-2 gets broken down every seven minutes. In adults with SBS, about half of GATTEX is broken down in approximately 1.3 hours. In the intestines, GATTEX was designed to increase the height of the villi, as well as the depth between each villus, to allow for more intestinal absorption, similar to the body's own GLP-2.

Talk with your doctor to learn more about GATTEX or visit GATTEX.com.

GATTEX Consumer Indication and 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.

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

Polyps in the intestines

Polyps are growths on the inside of the intestines. For adult patients, your healthcare provider will have your colon and upper intestines checked for polyps within 6 months before starting GATTEX, and have any polyps removed. To keep using GATTEX, your healthcare provider should have your colon and upper intestines checked for polyps at the end of 1 year of using GATTEX.

For pediatric patients, your healthcare provider will check for blood in the stool within 6 months before starting GATTEX. If there is blood in the stool, your healthcare provider will check your colon and upper intestines for polyps, and have any polyps removed. To keep using GATTEX, your healthcare provider will check for blood in the stool every year during treatment of GATTEX. If there is blood in the stool, your healthcare provider will check your colon and upper intestines for polyps. The colon will be checked for polyps at the end of 1 year of using GATTEX.

For adult and pediatric patients, if no polyp is found at the end of 1 year, your healthcare provider should check you for polyps as needed and at least every 5 years. If any new polyps are found, your healthcare provider will have them removed and may recommend additional monitoring. If cancer is found in a polyp, your 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 your healthcare provider right away if you have any of these symptoms of a bowel or stomal blockage:

  • trouble having a bowel movement or passing gas
  • stomach area (abdomen) pain or swelling
  • nausea
  • vomiting
  • swelling and blockage of your stoma opening, if you have a stoma

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

Swelling (inflammation) or blockage of your gallbladder or pancreas

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:

  • stomach area (abdomen) pain and tenderness
  • chills
  • fever
  • a change in your stools
  • nausea
  • vomiting
  • dark urine
  • yellowing of your skin or the whites of your eyes

Fluid overload

Your healthcare provider will check you for too much fluid in your body. Too much fluid in your body may lead to heart failure, especially if you have heart problems. Tell your healthcare provider if you get swelling in your feet and ankles, you gain weight very quickly (water weight), or you have trouble breathing.

The most common side effects of GATTEX in adults include:

  • stomach area (abdomen) pain or swelling
  • nausea
  • cold or flu symptoms
  • skin reaction where the injection was given
  • vomiting
  • swelling of the hands or feet
  • allergic reactions

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.

What should I tell my healthcare provider before using GATTEX?

Tell your healthcare provider about all your medical conditions, including if you or your child:

  • have cancer or a history of cancer
  • have or had polyps anywhere in your bowel (intestines) or rectum
  • have heart problems
  • have high blood pressure
  • have problems with your gallbladder, pancreas, kidneys
  • are pregnant or planning to become pregnant. It is not known if GATTEX will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while using GATTEX.
  • are breastfeeding or plan to breastfeed. It is not known if GATTEX passes into your breast milk. You should not breastfeed during treatment with GATTEX. Talk to your healthcare provider about the best way to feed your baby while using GATTEX.

Tell your healthcare providers about all the medicines you take, including prescription or 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.

Call your 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, see link to full Prescribing Information and Medication Guide, and discuss any questions with your doctors.

How GATTEX Works to Enhance Absorption1

The amino acid sequence of naturally occurring GLP-2 and GATTEX are nearly identical, except for a single amino acid substitution—alanine replaced with glycine1-4

Icons and background images are purely decorative elements and do not convey additional meaning, content, or information to users who rely on screen readers. As such, they do not require alt text for accessibility purposes. HIS A S P G LY SER SER A S P G LU MET A S N THR ILE LEU A S P A S N LEU ALA A S P THR ILE L Y S THR GLN ILE LEU TRP A S N PHE G LY ILE PHE A S P A RG ALA 1 10 20 30 GATTEX

The only difference in the amino acid sequence is alanine replaced with glycine

Mean Half-life of GATTEX in patients with SBS1:

~42 minutes (Age: 1-11 years)
~60 minutes (Age: 12-17 years)
~1.3 hours (Age: >17 years)

Half-life of naturally occurring
GLP-2 is ~7 minutes2,3

GATTEX Enhanced Intestinal Absorption
in Adult Patients With SBS1

INCREASED
VILLI HEIGHT

INCREASED
CRYPT DEPTH

A biopsy of villi

Not an actual biopsy. Image is for illustrative purposes only and does not represent results from the study.

GATTEX enhanced gastrointestinal fluid (wet weight) absorption in adults by approximately 750-1000 mL/day.1

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

Study design

The ability of GATTEX (teduglutide) to improve intestinal absorption was studied in 17 adult subjects with SBS (n=2-3 per dose group) using daily doses of 0.03, 0.1, or 0.15 mg/kg (doses ranging from 0.6 to 3 times the recommended dose) in a 21-day, open-label, multicenter, dose-ranging study. Fourteen of 17 patients were dependent on PS. All subcutaneous (abdomen) doses studied, except 0.03 mg/kg once daily, resulted in enhanced gastrointestinal fluid (wet weight) absorption of approximately 750 to 1000 mL/day, and increased villus height and crypt depth of the intestinal mucosa.1,4

The recommended dosage of GATTEX for both adult and pediatric patients is 0.05 mg/kg once daily by subcutaneous injection. The recommended dosage in adult and pediatric patients with moderate and severe renal impairment and end-stage renal disease (estimated glomerular filtration rate [eGFR] <60 mL/min/1.73 m2) is 0.025 mg/kg once daily.1