`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) » SHARPS DISPOSAL (/patient-
`support/sharps-disposal.aspx)
`
`Learn about Sharps Disposal
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`Hypothetical patient and doctor portrayal
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`Shire is committed to simplifying the process of obtaining GATTEX with a multifaceted
`support program, OnePath®. Through OnePath, patients receive personal, dedicated service
`to help navigate obtaining and receiving treatment with GATTEX.
`
`OnePath Case Managers notify GATTEX network specialty infusion pharmacies when
`GATTEX is prescribed for a patient. After GATTEX is delivered to the patient’s home, a home
`visit is scheduled for a nurse to conduct injection training, provide education about proper
`needle and syringe disposal, review the Medication Guide and ensure that the patient is
`aware of available resources. Also, the nurse disseminates patient resources about GATTEX
`including:
`Prescribing Information
`Instructions for Use (IFU)
`Medication Guide
`Patient Demonstration Kit
`Administration Video
`Patient and Caregiver Counseling Guide
`How GATTEX Works Brochure
`Patients are cautioned against the reuse of needles and syringes and they are provided
`education about disposal procedures. Patients are provided the following instructions:
`Do not reuse a syringe or needle.
`To help avoid needlestick injuries, do not recap a needle.
`Put your needles and syringes in an FDAcleared sharps disposal container right away
`after use. Do not throw away (dispose of) loose needles and syringes in your
`household trash.
`If you do not have an FDAcleared sharps disposal container, you may use a
`household container that is:
`• made of heavyduty plastic
`• can be closed with a tightfitting, punctureresistant lid, without sharp items being
`able to come out
`• upright and stable during use
`• leakresistant
`• properly labeled to warn of hazardous waste inside the container
`When your sharps disposal container is almost full, you will need to follow your
`community guidelines for the right way to dispose of your sharps disposal container.
`There may be local or state laws about how to throw away syringes and needles. For
`more information about safe sharps disposal, and for specific information about sharps
`disposal in the state that you live in, go to the FDA’s website at:
`http://www.fda.gov/safesharpsdisposal (http://www.fda.gov/safesharpsdisposal).
`Do not dispose of your sharps disposal container in your household trash unless your
`community guidelines permit this. Do not recycle your sharps disposal container.
`Throw away the GATTEX vial into the container where you put the syringes and
`needles.
`If you have any questions, talk to your healthcare provider or pharmacist.
`
`Patients who have additional questions or would like to receive copies of the patient
`resources can contact OnePath at
`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.
`
`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.
`
`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
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`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.
`
`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
`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
`
`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).
`
`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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