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.

Before you start using GATTEX, your healthcare provider will:

• Have your colon checked for polyps within 6 months before starting GATTEX.
• Have any polyps removed.
• Check for blood in the stool before children and adolescents 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.
• 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 eyes

These are not all the side effects of GATTEX. For more information, see “What are the possible side effects of GATTEX?”

What is GATTEX?

• 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, or kidneys.
• are pregnant or plan 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:

• See “What is the most important information I should know about GATTEX?”
• 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 right away 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.
These are not all of the possible side effects of GATTEX.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store GATTEX?

• 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.

Please see full Prescribing Information and Important Safety Information.