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Important Safety Information: GATTEX may cause serious side effects including making abnormal cells grow faster, polyps in the colon (large intestine), blockage of the bowels (intestines), swelling (inflammation) or blockage of your gallbladder or pancreas, and fluid overload. Click here for additional Important Safety Information.

Patient Support

Learn about the product support available for patients

Hypothetical patient and doctor portrayal

 

 

Short Bowel Syndrome is a rare condition and it’s not unusual for patients to feel alone. That’s why it’s important to connect with people who understand your situation.

Find a network of support today and start reaching out to others—you might even enjoy offering a helping hand.

Facebook

Facebook offers a number of support groups, including:

 

NORD Foundation

NORD (National Organization for Rare Disorders, Inc.) has been empowering the rare disease community for more than 30 years.

OLEY Foundation 

This organization is dedicated to enriching the lives of those requiring home IV and tube feeding through education, outreach and networking.

Global Genes 

Global Genes is one of the leading rare disease patient advocacy organizations in the world.

Crohn’s & Colitis Foundation of America 

The Crohn's & Colitis Foundation of America (CCFA) is a non-profit, volunteer-driven organization dedicated to finding the cures for Crohn's Disease and ulcerative colitis.

United Ostomy Association of America 

We invite you to explore this website to find information about ostomies.

International Federation of Functional Gastrointestinal Disorders 

An educational resource for reliable digestive health knowledge, support, and assistance about functional gastrointestinal (GI) and motility disorders (FGIMDs).

SBS Foundation 

This organization provides education, support and advocacy services for the short bowel community.

Some of the websites listed here allow for free exchange of information (for example, chat rooms and forums). Shire does not sponsor or endorse this free exchange of information. Shire is not responsible for the content or services provided by any websites that are not owned by Shire. Websites that are not owned by Shire are governed by their own polices and guidelines, including privacy policies.

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.

For additional safety information, click here for Prescribing Information and Medication Guide and discuss with your doctor.

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. You can also call Shire at 1-855-5GATTEX (1-855-542-8839).

What is GATTEX?

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