GATTEX^® (teduglutide [rDNA origin]) for 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 Full Prescribing Information Medication Guide Instructions For Use For Healthcare Providers

Kat is a real patient
taking GATTEX.

KAT'S STORY

Kat’s journey to diagnosis

Kat was nine years old when she was diagnosed with Crohn’s disease. Years later, a fistula opened from the inside out, acting like a homemade ostomy, but she didn't get proper medical care. She went on to college, hiding the secret hole in her gut, studied, worked and struggled to pretend everything was normal.

By her senior year, she couldn’t take it anymore. She wrote to a well-regarded health institute asking for help, and was encouraged to come quickly for a consultation. That’s where she met the surgeon who performed her first bowel resection. He tried to preserve as much intestine as he could but unfortunately had to remove 85% of her total intestines.

After surgery, Kat had a brand-new ostomy with the possibility of getting her intestines reconnected in a year or so, if she healed well. She was almost pain-free for the first time in fifteen years. She went back to school, but over the course of the following six months, she was in and out of the hospital to get rehydrated and nourished. She went back to her surgeon who then officially diagnosed her with Short Bowel Syndrome (SBS).

Starting parenteral support (PS)

After her diagnosis, Kat began taking daily IV nutrition at home. She hadn’t been well-nourished or hydrated since she was 7 years old, so Kat was excited about her PS regimen. TPN didn't stop her from traveling to Europe. A year later, her surgeon was able to reconnect her intestines. After Kat began seriously pursuing her acting career, she found that PS came with challenges. She was infusing 5-6 liters of TPN and hydration over 12-16 hours every day so she couldn’t sleep more than an hour or two at night because of frequent bathroom trips.

Learning about GATTEX^®

Kat was feeling frustrated with her total parenteral nutrition (TPN) regimen, so she began to explore different treatment options with her healthcare team.

Through her research, she heard about a peptide being used in clinical trials at Intestinal Rehab centers. Now called GATTEX, it’s a prescription medicine used in adults with Short Bowel Syndrome (SBS) who need additional nutrition or fluids from IV feeding. She was persistent about getting into a study. The doctors explained the possible benefits to her, as well as the possible serious risks, including making abnormal cells grow faster, polyps in the colon and bowel blockage.

What would a day off PS mean to you?

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. GATTEX helped the majority of patients:

Reduce weekly PS volume

GATTEX 63% reduced PS by 20% or more

Placebo 30% reduced PS by 20% or more

Get more day(s) off weekly PS

GATTEX 54% achieved at least 1 day off PS

Placebo 23% achieved at least 1 day off PS

This is Kat's story.

More day(s) off PN

Less time infusing this weekend

Kat is a real patient
taking GATTEX.

Kat’s doctors reduced her PS volume over time

Over time, while Kat was on GATTEX, her doctor was able to cut her weekly IV nutrition back. She’s now infusing 5 liters a week instead of 5 liters a day! She’s hooked up to one liter of TPN four nights a week for eight hours and during one of her 3 nights off of TPN, she infuses one liter of hydration over four hours.

Kat did experience gas and bloating, but that’s just her experience. Everyone is unique, and responds differently to treatment. Her doctors continue to monitor her condition, including any side effects.

Spending less time infusing gives Kat freedom to do the things she enjoys

On the nights she’s spending 4 hours infusing hydration vs. 12-14 hours infusing TPN, she can stay out later to socialize with friends and go to a restaurant for dinner. But people with SBS have to keep up communication with their doctors and healthcare team.

Now that she spends less days hooked up to TPN, Kat plans on traveling more, spending time with friends and working on her book and other projects. Kat feels a personal responsibility to keep going in her life. She believes that on the other side of heartbreak, there's wisdom.

“You’d be surprised where you can find an open door where it seems there is none.”

Want to talk with someone who takes GATTEX?

If you’re living with SBS or you care for someone who does, you aren’t alone. Schedule a call with a GATTEX Patient Ambassador through our mentor program, SBS Connect, or see if there’s a live event in an area near you.

Betsy's Story

Reta's Story

Lynda's Story

Peggy's Story

Roy's Story

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. Polyps were found in patients taking GATTEX in clinical studies. 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. Bowel blockage was reported in patients taking GATTEX in clinical studies. Tell your healthcare provider if you have any of these symptoms of a bowel 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 blockage is found, your healthcare provider may temporarily stop GATTEX.

Swelling (inflammation) or blockage of your gallbladder or pancreas

Swelling or blockage of the gallbladder or pancreas were reported in patients taking GATTEX in clinical studies. 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, change in your stools, nausea, vomiting, dark urine, or yellowing of your skin or the whites of eyes.

Fluid overload

Fluid overload and heart failure were reported in patients taking GATTEX in clinical studies. Too much fluid in your body may lead to heart failure, especially if you have heart problems. Your healthcare provider will check you for too much fluid in your body. 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:

stomach area (abdomen) pain or swelling
skin reaction where the injection was given
nausea
headache
cold or flulike symptoms
vomiting

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 if you:

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
have any other medical condition
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 and your healthcare provider should decide if you will use GATTEX or breastfeed. You should not do both.

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 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 Prescribing Information and Medication Guide and discuss with your doctor.

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.