PS* reductions may be within reach

“Under the supervision of my doctor, my PS was reduced over time.”

—Lynda, Gattex Patient

*Parenteral support (PS) is additional nutrition or fluids from intravenous (IV) feeding.

Patients needed less weekly PS volume

GATTEX was studied in a 6-month clinical trial of 86 adult SBS patients who needed to use PS at least 3 times a week for at least 1 year. A total of 43 patients received GATTEX and 43 patients received placebo, but the patients were not told which one they were taking. Patients did not know if they were receiving once-daily GATTEX (0.05 mg/kg) or placebo, which is a treatment with no actual medication. The goal of the study was to see if significantly more patients on GATTEX achieved a reduction in weekly PS volume of at least 20% compared to patients taking placebo at weeks 20 and 24.

In clinical trials, after 6 months, GATTEX helped patients:

Reduce Weekly PS Volume


Gattex Patients
Image of PS bag icon. PS reductions with GATTEX

63% reduced weekly PS by 20% or more (27 out of 43 patients)

Placebo Patients

30% reduced weekly PS by 20% or more (13 out of 43 patients)

Get More Day(s) Off Weekly PS


Gattex Patients
Image of calendar icon. Days off PS with GATTEX

54% achieved at least 1 day off of PS (21 out of 39 patients)

Placebo Patients

23% achieved at least 1 day off of PS (9 out of 39 patients)

In the STEPS clinical study, PS reduction was evaluated in all patients who were randomized into the trial.

In the STEPS clinical study, day(s) off PS were evaluated in all patients completing 24 weeks of treatment with GATTEX or placebo.

After the study began, 4 patients receiving GATTEX and 4 patients receiving placebo stopped receiving treatment. This left 78 patients to evaluate.


GATTEX reduced PS in most patients

In a 24-month long-term study:

The goal of this study was to evaluate the efficacy and safety of GATTEX over 2 years.

76 of the 78 patients who completed the first study decided to participate in the long-term study. They were joined by an additional 12 adults who were receiving PS at least 3 times a week for at least 1 year, for a total of 88 participants. All of the people in this study knew they were taking GATTEX.

Weekly PS Volume Reduction After 24 Months


Gattex Patients
Volume reduction

55% reduced weekly PS by 20% or more (16 out of 29 patients)

29 patients completed 24 months of GATTEX treatment. (They took placebo in study 1, then GATTEX in study 2.)

Weekly PS Volume Reduction After 30 Months


Gattex Patients
1 day off

93% reduced weekly PS by 20% or more (28 out of 30 patients)

30 patients completed a total of 30 months of GATTEX treatment. (They took GATTEX in study 1 and GATTEX in study 2.)

More Day(s) off of PS May Be Possible

After completing 30 months of Gattex treatment:

Image of 10 out of 30 patients graphic

10 out of 30 patients weaned off of PS completely§

(33%)


Image of 18 out of 30 patients graphic

18 out of 30 patients achieved at least 3 days off of PS per week

(60%)


Image of 21 out of 30 patients graphic

21 out of 30 patients achieved at least 1 day off of PS per week

(70%)

For more information about these results, talk to your doctor.

§Patients were maintained on GATTEX even if no longer requiring parenteral support.

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

GATTEX® (teduglutide) for subcutaneous injection is a prescription medicine used in adults with Short Bowel Syndrome (SBS) who need additional nutrition or fluids from intravenous (IV) feeding (parenteral support).

Click here for additional Important Safety Information.

What is GATTEX?

GATTEX® (teduglutide) for subcutaneous injection is a prescription medicine used in adults with Short Bowel Syndrome (SBS) who need additional nutrition or fluids from intravenous (IV) feeding (parenteral support).

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 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 colon (large intestine)

Polyps are growths on the inside of the colon. Your healthcare provider will have your colon 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 checked for new polyps at the end of 1 year of using GATTEX. If no polyp is found, your healthcare provider should check you for polyps as needed and at least every 5 years and have any new polyps removed. 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:

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:

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 include:

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:

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, click here for full Prescribing Information.