Hypothetical patient portrayal
After you talk with your doctor and decide to begin treatment with GATTEX®, your prescription medication will be shipped directly to your home.
How should I use GATTEX?
• You should 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 pre-filled 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.
• Read the Instructions for Use for detailed instructions for preparing and injecting a dose of GATTEX.
• Read the Medication Guide and Instructions for Use carefully before you start GATTEX and each time you get a refill. There may be new information.
• Your healthcare provider or nurse should show you how to prepare, measure your dose, and give your injection of GATTEX the right way.
• If you cannot give yourself the injection, ask your healthcare provider or nurse to help you or ask someone who has been trained by a healthcare provider or nurse to give your injections.
How should I store 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 medications out of the reach of children.
Talk to your doctor to see if GATTEX is right for you.
Print out and bring the GATTEX Start Form to your next doctor's visit.
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. 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
- 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 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
- cold or flulike symptoms
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 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 and Medication Guide 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 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).