GATTEX- teduglutide injection, powder, lyophilized, for solution 
GATTEX- teduglutide 
Shire-NPS Pharmaceuticals, Inc.



GATTEX® (Ga'-tex)
(teduglutide [rDNA origin])
for injection

Read this Medication Guide carefully before you start taking GATTEX® and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical problems or treatment.

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

GATTEX may cause serious side effects, including:

Polyps in the colon (large intestine). Polyps are growths on the inside of the colon.

Before you start using GATTEX, your healthcare provider will:

To keep using GATTEX, your healthcare provider should:

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 if you have any of these symptoms of a bowel blockage:

If 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
  • change in your stools
  • nausea
  • vomiting
  • dark urine
  • yellowing of your skin or the whites of eyes

These are not all the side effects of GATTEX. For more information, see "What are the possible side effects of GATTEX?"

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).

It is not known if GATTEX is safe or effective in children.

What should I tell my healthcare provider before using GATTEX?

Before you use GATTEX, tell your healthcare provider if you:

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

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use GATTEX?

What are the possible side effects of GATTEX?

GATTEX may cause serious side effects, including:

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.

These are not all of the possible side effects of GATTEX.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store GATTEX?

Keep GATTEX and all medicines out of the reach of children.

General information about the safe and effective use of GATTEX

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use GATTEX for a condition for which it was not prescribed. Do not give GATTEX to other people, even if they have the same symptoms that you have. It may harm them.

If you would like more information about GATTEX talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about GATTEX that is written for health professionals.

For more information go to or call 1-800-828-2088.

What are the ingredients in GATTEX?

Active ingredient: teduglutide

Inactive ingredients: L-histidine, mannitol, monobasic sodium phosphate monohydrate, and dibasic sodium phosphate heptahydrate.

Sterile Water for Injection is provided as a diluent.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured for:
Shire-NPS Pharmaceuticals, Inc.
300 Shire Way
Lexington, MA 02421

GATTEX® is a registered trademark of Shire-NPS Pharmaceuticals, Inc.

©2016 Shire-NPS Pharmaceuticals, Inc.

Revised: 07/2016

U.S. License No.203441

Revised: 10/2016
Shire-NPS Pharmaceuticals, Inc.