Gattex ® (Teduglutide [rDNA origin]) for Injection is indicated for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support.
Gattex has been approved with a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of Gattex outweigh the potential risks.
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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 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
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
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.
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.
stomach area (abdomen) pain or swelling
skin reaction where the injection was given
cold or flu like symptoms
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
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. To report suspected side effects, contact NPS Pharmaceuticals at 1-855-5GATTEX (1-855-542-8839) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.