How to
start Gattex

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talking to your doctor

Talk to your or your loved one's doctor

Make an appointment to speak with a healthcare provider.

The Conversation Guide may help guide discussions with your or your loved one’s doctor about whether GATTEX is the right treatment option. It is important to fully understand the possible risks and benefits of treatment.

Download conversation guide
Form

Complete the Start Form

After deciding to move forward with GATTEX, make sure to complete and sign the GATTEX Start Form with your or your loved one’s doctor. This serves as the prescription and allows OnePath® to begin working with eligible patients.

This start form should be completed with your or your loved one’s doctor.

Download form
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Connect with OnePath—
personalized product support

OnePath provides product support services for eligible GATTEX patients throughout the Takeda treatment journey. From the moment you or your loved one enrolls in OnePath, a dedicated Patient Support Manager (PSM) will assist with access to treatment and support. You’ll also be introduced to an Onboarding & Access Specialist (OAS) in your area, who will be one of your primary contacts as you get started on therapy. Once you have connected with your or your loved one’s PSM, they will help:

  • Arrange delivery of GATTEX to you or the location where treatment is received
  • Schedule training with a nurse educator to show you and/or your caregiver how to prepare, measure specific doses, and take GATTEX according to the prescribing information
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How to take GATTEX

Once you are ready to begin GATTEX, be sure to follow the training provided by your healthcare provider. The instructions below show you step-by-step how to inject GATTEX. Once trained by a healthcare provider, adults can self-administer. For children, GATTEX must be administered by an adult. Self-administration is not recommended in pediatric patients.

Instructions for Use (IFU)

Get step-by-step instructions for injecting GATTEX. It may be helpful to print a copy and keep it with your GATTEX supplies.

Download the ifu

Using GATTEX

  • Use GATTEX exactly as your healthcare provider tells you to
  • GATTEX is given 1 time each day at the same time
  • Inject your dose of GATTEX under the skin (subcutaneous injection) in your stomach area (abdomen), upper legs (thighs), or upper arms. Do not inject GATTEX into a vein or muscle
  • Use a different injection site each time you use GATTEX
  • GATTEX comes as a powder for injection in a vial that is used only 1 time (single-use vial). The powder must be mixed with Sterile Water for Injection (a diluent) provided in a prefilled syringe before you inject it
  • GATTEX must be injected within 3 hours after you mix it with the diluent
  • If you miss a dose, take it as soon as you remember that day. Take your next dose the next day at the same time you take it every day
  • Do not take 2 doses on the same day
  • If you use more than 1 dose, call your healthcare provider right away
  • Do not stop taking GATTEX without consulting your healthcare provider
  • Read the Instructions for Use for detailed instructions for preparing and injecting a dose of GATTEX

Storing GATTEX

  • Store GATTEX powder at room temperature up to 25°C (77°F)
  • Do not freeze GATTEX
  • Use the GATTEX powder by the expiration date on the “Use By” sticker on the kit
  • Use GATTEX within 3 hours after mixing it
  • Throw away any unused GATTEX that has been mixed, even if there is medicine left in the vial
  • Do not store any GATTEX you have mixed

Keep GATTEX and all medicines out of the reach of children.

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What is GATTEX?

GATTEX® (teduglutide) for subcutaneous injection is a prescription medicine used in adults and children 1 year of age and older with Short Bowel Syndrome (SBS) who need additional nutrition or fluids from intravenous (IV) feeding (parenteral support). It is not known if GATTEX is safe and effective in children under 1 year of age.

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)

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. Children and adolescents will be checked for blood in the stool before they start 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. Tell your healthcare provider right away if you have any of these symptoms of a bowel or stomal 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 a 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
  • a change in your stools
  • nausea
  • vomiting
  • dark urine
  • yellowing of your skin or the whites of your eyes

Fluid overload

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.

The most common side effects of GATTEX in adults include:

  • stomach area (abdomen) pain or swelling
  • nausea
  • cold or flu symptoms
  • skin reaction where the injection was given
  • vomiting
  • swelling of the hands or feet
  • allergic reactions

The side effects of GATTEX in children and adolescents are similar to those seen in adults.

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 about all your medical conditions, including if you or your child:

  • 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
  • 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 should not breastfeed during treatment with GATTEX. Talk to your healthcare provider about the best way to feed your baby while using GATTEX.

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 (medicines taken by mouth) 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. You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For additional safety information, click here for full Prescribing Information and Medication Guide, and discuss any questions with your doctor.

What is GATTEX?

GATTEX® (teduglutide) for subcutaneous injection is a prescription medicine used in adults and children 1 year of age and older with Short Bowel Syndrome (SBS) who need additional nutrition or fluids from intravenous (IV) feeding (parenteral support). It is not known if GATTEX is safe and effective in children under 1 year of age.

Important Safety Information

GATTEX may cause serious side effects, including making abnormal cells grow faster, polyps in the colon (large intestine), blockage of the bowel (intestines), swelling (inflammation) or blockage of your gallbladder or pancreas, and fluid overload. Click here for additional Important Safety Information.

Are you a healthcare professional?

The information in the section of the site you are about to see is intended for US healthcare professionals only. Click OK if you are a US healthcare professional.