Gattex

Gattex is a prescription medication used to treat Short Bowel Syndrome (SBS) in adults who need extra nutrition or fluids from intravenous feeding (parenteral support). Gattex is a glucagon-like peptide, which helps the intestines absorb nutrients and fluid.

This medication comes in an injectable form. It is injected just under the skin (subcutaneously) once a day in the stomach area, upper legs, or upper arms.

Common side effects include abdomen (stomach area) pain or swelling, nausea, and a skin reaction at the injection site.

Gattex is part of the drug class:

• Various alimentary tract and metabolism products

Gattex may cause serious side effects, including:

• See "Drug Precautions" section.

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 include:

• stomach area (abdomen) pain or swelling
• skin reaction where the injection was given
• nausea
• headache
• cold or flu like symptoms
• vomiting

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 the FDA at 1-800-FDA-1088.

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.

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 increase risk that abnormal cells could become cancer. If you get cancer of the bowel (intestines), liver, gall bladder, or pancreas while using Gattex, your healthcare provider should stop Gattex. If you get other types of cancers, you and your healthcare provide 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

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 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
  • nausea
  • vomiting
  • 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.

• 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
• nausea
• vomiting
• chills
• fever
• change in your stools
• dark urine
• yellowing of your skin or the whites of eyes

These are not all the side effects of Gattex. For more information, see "Side Effects" section.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Gattex, there are no specific foods that you must exclude from your diet when receiving this medication.

If you take too much Gattex, call your healthcare provider right away or seek emergency medical attention.

Short Bowel Syndrome

Treatment of short bowel syndrome in patients dependent on parenteral support (designated an orphan drug by FDA for use in this condition).1 2 4 5

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Abdominal or stomach pain
• decrease in the amount of urine
• excess air or gas in the stomach or intestines
• fast heartbeat
• fever
• full or bloated feeling
• hives
• hoarseness
• irritation
• itching
• joint pain, stiffness, or swelling
• noisy, rattling breathing
• pressure in the stomach
• rash
• redness of the skin
• swelling of the abdominal or stomach area
• swelling of the eyelids, face, lips, hands, or feet
• swelling of the fingers, hands, feet, or lower legs
• tightness in the chest
• troubled breathing at rest
• troubled breathing or swallowing
• weight gain

• Indigestion
• severe nausea or vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Body aches or pain
• changes in appetite
• chills
• cough
• ear congestion
• headache
• loss of voice
• nasal congestion
• nausea
• runny nose
• sneezing
• sore throat
• trouble sleeping
• unusual tiredness or weakness
• vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• It is used to treat short bowel syndrome.

• Store at room temperature. Do not freeze.
• Throw away any part not used after 3 months.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Applies to teduglutide: subcutaneous powder for solution

Along with its needed effects, teduglutide (the active ingredient contained in Gattex) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking teduglutide:

• Abdominal or stomach pain
• decrease in the amount of urine
• excess air or gas in the stomach or intestines
• fast heartbeat
• fever
• full or bloated feeling
• hives
• hoarseness
• irritation
• itching
• joint pain, stiffness, or swelling
• noisy, rattling breathing
• pressure in the stomach
• rash
• redness of the skin
• swelling of the abdominal or stomach area
• swelling of the eyelids, face, lips, hands, or feet
• swelling of the fingers, hands, feet, or lower legs
• tightness in the chest
• troubled breathing at rest
• troubled breathing or swallowing
• weight gain

• Indigestion
• severe nausea or vomiting

Some side effects of teduglutide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Body aches or pain
• changes in appetite
• chills
• cough
• ear congestion
• headache
• loss of voice
• nasal congestion
• nausea
• runny nose
• sneezing
• sore throat
• trouble sleeping
• unusual tiredness or weakness
• vomiting