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GATTEX- teduglutide injection, powder, lyophilized, for solutionGATTEX- teduglutide kit


  1. Patient Information
  2. What Should I Tell My Healthcare Provider Before Using Gattex?before Using Gattex, Tell Your Healthcare Provider About All Your Medical Conditions, Including If You Or Your Child:
  3. How Should I Use Gattex?
  4. Gattex May Cause Serious Side Effects, Including:
  5. What Are The Ingredients In Gattex?active Ingredient:
  6. Inactive Ingredients:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

Acceleration of Neoplastic Growth

Advise patients and their caregivers that they will need to undergo clinical examinations and repeated colonoscopies (or alternate imaging/diagnostics, such as fecal occult blood testing) during treatment with GATTEX to monitor for the development of polyps and/or neoplasia of the GI tract[
GATTEX 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.

What Should I Tell My Healthcare Provider Before Using Gattex?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. Talk to your healthcare provider about the best way to feed your baby while using GATTEX. Breastfeeding is not recommended during treatment with GATTEX.
Tell your healthcare providers about all the medicines you take,including prescription and 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.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How Should I Use Gattex? 

  • Use GATTEX exactly as your healthcare provider tells you to.
  • Your healthcare provider or nurse should show you how to prepare, measure your dose, and give your injection of GATTEX.Self-administration is not recommended in pediatric patients.
  • GATTEX comes as a 5 mg kit. Use of the GATTEX 5 mg kit is not recommended in pediatric patients weighing less than 22 pounds (10 kg).
  • 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 dose 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.
What are the possible side effects of GATTEX?

Gattex May Cause Serious Side Effects, Including: 

    • Store GATTEX powder at room temperature up to 77 F (25 C).
    • 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.General information about the safe and effective use of GATTEX.
    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use GATTEX for a condition for which it was not prescribed. Do not give GATTEX to other people, even if they have the same symptoms that you have. It may harm them.
    If you would like more information about GATTEX talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about GATTEX that is written for health professionals.

What Are The Ingredients In Gattex?active Ingredient: 

teduglutide

Inactive Ingredients: 

dibasic sodium phosphate heptahydrate, L-histidine, mannitol, and monobasic sodium phosphate monohydrate. Sterile Water for Injection is provided as a diluent.
Manufactured for:
Shire-NPS Pharmaceuticals, Inc.
300 Shire Way
Lexington, MA 02421
USA
GATTEX is a registered trademark of Shire-NPS Pharmaceuticals, Inc., a Takeda company.
2019 Takeda Pharmaceutical Company Limited. All rights reserved.
For more information, go to www.GATTEX.com or call 1-800-828-2088.



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