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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.
`
`HOME (/home.aspx) » GETTING STARTED (/getting-started.aspx) » WHY CHOOSE
`GATTEX? (/getting-started/why-choose-gattex.aspx)
`
`Why Choose GATTEX ?®
`
`https://www.gattex.com/getting-started/why-choose-gattex.aspx
`
`CFAD Exhibit 1061
`CFAD v. NPS
`IPR2015-00990
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`Hypothetical patient portrayal
`
`Learn more about how adults with Short Bowel Syndrome who needed
`additional nutrition or fluids from intravenous (IV) feeding (parenteral
`support) responded to once-daily GATTEX in clinical studies. GATTEX may
`help the remaining bowel absorb more. Remember, individual results may
`vary.
`
`GATTEX helped patients reduce their weekly parenteral support* after 6
`months of treatment in a clinical trial
`
`• 63% of patients taking GATTEX responded to treatment compared with 30% of
`patients taking a placebo
`
`• Response to treatment was defined as a reduction in parenteral support by 20% or
`more per week
`
`GATTEX helped reduce the average weekly volume and the number of day
`(s) on parenteral support after 6 months of treatment in a clinical trial
`
`• Patients taking GATTEX reduced their weekly parenteral support on average by 4.4
`liters per week compared with 2.3 liters for patients on placebo
`
`• Over 50% of patients who took GATTEX reduced their use of parenteral support by 1
`day or more compared with 23% of patients taking a placebo
`
`https://www.gattex.com/getting-started/why-choose-gattex.aspx
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`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
`
`• Fluid overload
`
`In a 2-year study, where patients knew they were taking once-daily
`GATTEX, the following results were seen:
`
`In the 30 patients who received a total of 2.5 years of treatment with GATTEX:
`
`• 93% reduced their weekly parenteral support by 20% or more
`
`• Average reduction of 7.55 liters per week of parenteral support compared to before
`starting GATTEX
`
`• 70% of patients reduced their use of parenteral support by at least 1 day
`
`• 10 patients were weaned off their parenteral support
`
`In the 29 patients who received a total of 2 years of treatment with GATTEX:
`
`• 55% reduced their weekly parenteral support by 20% or more
`
`• Average reduction of 3.11 liters per week compared to before they started GATTEX
`
`• 48% of patients reduced their use of parenteral support by at least 1 day
`
`• 2 patients were weaned off their parenteral support
`
`* Parenteral support refers to food and fluids that are given to you through your veins rather than by
`mouth and includes both parenteral nutrition and/or intravenous (IV) fluids.
`
`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.
`
`https://www.gattex.com/getting-started/why-choose-gattex.aspx
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`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.
`
`https://www.gattex.com/getting-started/why-choose-gattex.aspx
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`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)
`
`https://www.gattex.com/getting-started/why-choose-gattex.aspx
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`®
`indirect subsidiary of Shire North American Group, Inc. ©2016 Shire. All rights
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`S10472 01/16
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`https://www.gattex.com/getting-started/why-choose-gattex.aspx
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