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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.
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`About GATTEX®
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`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).
`GATTEX may:
`• Help the remaining intestine (bowel) absorb more
`• Reduce the need for parenteral support
`It’s important to remember that individual results may vary and you should talk with
`your doctor (/About-Gattex/Talking-With-Your-Doctor.aspx) about whether GATTEX is
`right for you.
`Learn more about getting started on GATTEX (/Getting-Started.aspx).
`
`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
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`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
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`• vomiting
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`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
`(http://www.shirecontent.com/PI/PDFS/Gattex_USA_ENG.pdf) and Medication
`Guide
`(http://www.shirecontent.com/MEDGUIDE/PDFs/MG_Gattex_USA_ENG.pdf)
`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
`(http://www.fda.gov/Safety/MedWatch/default.htm) 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).
`
`(http://www.shire.com)
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`policy) Terms of Use (/terms-of-use.aspx) Contact Us
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`GATTEX is a registered trademark of NPS Pharmaceuticals, Inc., a wholly-owned,
`®
`indirect subsidiary of Shire North American Group, Inc. ©2016 Shire. All rights
`reserved.
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`reasonable efforts to include accurate, up-to-date information on the site, Shire US Inc. makes no warranties or
`representations as to its accuracy. Shire US Inc. assumes no liability for any errors or omissions in the content of the site.
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