`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) » PATIENT SUPPORT (/patient-support.aspx) » PATIENT ASSISTANCE PROGRAM
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`Patient assistance program
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`Hypothetical patient and doctor portrayal
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`Make the Connection With OnePath
`OnePath is a customized support program that provides assistance for people who are
`starting treatment with GATTEX.
`
`Starting a new treatment can be overwhelming. You may not know where to go for answers,
`whom to talk to, or even what to ask.
`
`OnePath offers support that is personal, caring and confidential. You will be assigned a
`designated Case Manager—an experienced guide who will work with you to get started and
`help navigate the challenges you may encounter while on treatment.
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`To connect with a Case Manager, please call the OnePath Team at 18668880660.
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`Download the Start Form below, and bring it to your next Doctor's appointment. If your
`Doctor thinks that GATTEX is right for you, then you will complete this form together so that
`you can access the resources and support offered by OnePath.
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` (/assets/pdf/StartForm.pdf)
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`Our Case Managers can help you manage challenges that can prevent you from
`accessing your therapy. Your Case Manager can help you with:
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`Insurance Assistance
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`When you’re navigating insurance, it helps to have an experienced guide. Your OnePath
`Case Manager will work with you to confirm authorizations and benefit approvals for GATTEX
`and help you resolve health insurance issues you may face. If you need assistance with your
`copay or don’t have insurance, we can help you identify sources of assistance.
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`Benefits Verification
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`Will your insurance company cover GATTEX? We’ll check into it for you. We’ll also find out if
`you can expect copayments or outofpocket expenses. If there are challenges with your
`insurance coverage, we can help navigate these issues.
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`Copay Assistance
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`If you have commercial insurance but need assistance with outofpocket expenses, you may
`be eligible for our OnePath CoPay Assistance Programs. Your Case Manager can guide you
`through the process and help you follow up on your application.
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`Product Access Program
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`If you are uninsured or have insurance that does not cover GATTEX, you may be eligible for
`our OnePath Patient Assistance Program. Your Case Manager is committed to helping you
`explore all of the options available to give you access to the therapy your doctor has
`prescribed.
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`If you have questions about GATTEX, we’ll help you get answers. To reach a Case Manager,
`call 18668880660.
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`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.
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`Polyps in the colon (large intestine)
`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.
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`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.
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`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
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`If blockage is found, your healthcare provider may temporarily stop GATTEX.
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`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.
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`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.
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`The most common side effects of GATTEX include:
`stomach area (abdomen) pain or swelling
`skin reaction where the injection was given
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`nausea
`headache
`cold or flulike symptoms
`vomiting
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`Tell your healthcare provider if you have any side effect that bothers you or that does not go
`away.
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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.
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`Tell your healthcare providers about all the medicines you take, including prescription or
`overthecounter 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
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`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 1800FDA1088. You can also call
`Shire at 18555GATTEX (18555428839).
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`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).
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`GATTEX is a registered trademark of NPS Pharmaceuticals, Inc., a wholly-owned,
`subsidiary of Shire North American Group, Inc. ©Shire. All rights reserved.
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