Gattex is a man-made form of an amino acid that affects the processes of growth and function of cells in the stomach and intestines.

Gattex is a prescription medicine used to treat short bowel syndrome in adults and children at least 1 year old who depend on intravenous (parenteral) feeding to receive nutrition.

You should not use Gattex if you are allergic to teduglutide, or if you have cancer of the stomach, intestines, liver, gallbladder, or pancreas.

Before using Gattex, tell your doctor if you have heart disease, kidney disease, intestinal polyps, a blockage in your stomach or intestines, a colostomy or ileostomy, or a history of gallbladder or pancrease problems.

Teduglutide can make it easier for your body to absorb any medicines you take by mouth. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Gattex may increase your risk of colon polyps (in your large intestine). You will need a colonoscopy before and during treatment with Gattex. Teduglutide may also increase your risk of certain types of cancer. Talk with your doctor about the risks and benefits of this medicine.

Call your doctor at once if you have severe constipation, stomach cramps, fever, chills, nausea, vomiting, dark urine, or yellowing of your skin or eyes.

While using Gattex, you may need frequent blood tests (every 6 months), and then a colonoscopy after 1 year of treatment. If you use this medication long-term, you may need a colonoscopy every 5 years.

Before taking this medicine

Gattex can cause any abnormal cells in your body to grow faster. Some abnormal cells could become cancerous, increasing your risk of cancer of the liver, gallbladder, pancreas, or intestines. Ask your doctor about your specific risk.

Gattex may also increase your risk of polyps in your colon (large intestine). You will need a colonoscopy before and during treatment with teduglutide.

Talk with your doctor about the risks and benefits of this medicine.

To make sure Gattex is safe for you, tell your doctor if you have:

• cancer;

• polyps in your intestines or rectum;

• a blockage in your digestive tract (stomach or intestines), a colostomy or ileostomy;

• heart problems, high blood pressure;

• kidney disease; or

• problems with your gallbladder or pancreas.

Short bowel syndrome can increase your risk of malnutrition during pregnancy. This could lead to premature delivery, low birth weight, birth defects, or other complications in both mother and baby. Follow your doctor's instructions about using this medicine if you are pregnant.

You should not breastfeed while using this medicine.

Take Gattex exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Use the medicine at the same time each day.

Gattex is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself or how to give an injection to a child using teduglutide. Do not inject into a vein or muscle.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Gattex must be mixed with a liquid (diluent) before using it. When using injections by yourself, be sure you understand how to properly mix and store the medicine. Mixed medicine must be used within 3 hours.

Prepare an injection only when you are ready to give it. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

You may need blood tests every 6 months while using Gattex. Your stools may need to be checked for blood every 12 months. You may also need a colonoscopy after 1 year of treatment, and then once every 5 years if you use Gattex long-term.

Do not change your dose or dosing schedule without your doctor's advice.

Store unmixed powder at room temperature. Do not freeze and do not shake the vial. Throw away any Gattex not used before the expiration date on the medicine label.

Each vial (bottle) is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Usual Adult Dose for Short Bowel Syndrome:

0.05 mg/kg via subcutaneous injection once a day

Comments:
-Injection sites should be alternated, and may include the thighs, arms, and abdominal quadrants.
-IV and IM administration should be avoided.
-Missed doses should be taken as soon as possible on that day; patients should not take 2 doses on the same day.

Use: Treatment of patients with short bowel syndrome who are dependent on parenteral support

Gattex can cause any abnormal cells in your body to grow faster. Some abnormal cells could become cancerous, increasing your risk of cancer of the liver, gallbladder, pancreas, or intestines. Ask your doctor about your specific risk.

Gattex may also increase your risk of polyps in your colon (large intestine). You will need a colonoscopy before and during treatment with teduglutide.

Talk with your doctor about the risks and benefits of this medicine.

To make sure Gattex is safe for you, tell your doctor if you have:

• cancer;

• polyps in your intestines or rectum;

• a blockage in your digestive tract (stomach or intestines), a colostomy or ileostomy;

• heart problems, high blood pressure;

• kidney disease; or

• problems with your gallbladder or pancreas.

Short bowel syndrome can increase your risk of malnutrition during pregnancy. This could lead to premature delivery, low birth weight, birth defects, or other complications in both mother and baby. Follow your doctor's instructions about using this medicine if you are pregnant.

You should not breastfeed while using this medicine.

Use the medicine as soon as you remember, and then go back to your regular injection schedule. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Gattex: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe constipation or stomach cramps, nausea, vomiting;

• swelling in your hands and feet, rapid weight gain, feeling short of breath;

• a change in your stools (bowel movements);

• severe pain in your upper stomach spreading to your back;

• fever, chills; or

• dark urine or yellowing of your skin or eyes.

Common Gattex side effects may include:

• an allergic reaction;

• stomach pain or swelling;

• nausea, vomiting;

• cold or flu symptoms;

• swelling in your hands or feet; or

• pain, swelling, redness, or other irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Teduglutide can make it easier for your body to absorb any medicines you take by mouth, which could increase your blood levels of those medicines or cause unwanted effects. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products.