Teduglutide

Teduglutide is a prescription medication used to treat Short Bowel Syndrome (SBS) in adults who need extra nutrition or fluids from intravenous feeding (parenteral support). Teduglutide 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.

Teduglutide is a prescription medicine used in adults with Short Bowel Syndrome (SBS) who need additional nutrition or fluids from intravenous (IV) feeding (parenteral support).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Teduglutide may be found in some form under the following brand names:

• Gattex

Teduglutide 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 teduglutide 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 teduglutide.

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 teduglutide 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 teduglutide. Tell the healthcare provider who gives you teduglutide if you will be taking a new oral medicine.

Teduglutide may cause serious side effects, including:

Making abnormal cells grow faster.

• Teduglutide 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 teduglutide, your healthcare provider should stop teduglutide. If you get other types of cancers, you and your healthcare provide should discuss the risks and benefits of using teduglutide.

Polyps in the colon (large intestine).

• Polyps are growths on the inside of the colon.

Before you start using teduglutide, your healthcare provider will:

• Have your colon checked for polyps within 6 months before starting teduglutide
• Have any polyps removed

To keep using teduglutide, your healthcare provider should:

• Have your colon checked for new polyps at the end of 1 year of using teduglutide. 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 teduglutide.

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 teduglutide.

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 teduglutide and at least every 6 months while you are using teduglutide.

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 teduglutide. 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 teduglutide, there are no specific foods that you must exclude from your diet when receiving this medication.

Before you use teduglutide, 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 
• are breastfeeding or plan to breastfeed

Tell your healthcare providers about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using teduglutide 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 teduglutide. Tell the healthcare provider who gives you teduglutide 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.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Teduglutide falls into category B. There are no well-done studies that have been done in humans with teduglutide. But in animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if teduglutide passes into your breast milk. You and your healthcare provider should decide if you will use teduglutide or breastfeed. You should not do both.

Use teduglutide exactly as your healthcare provider tells you to.

• Teduglutide is given 1 time each day at the same time.
• Inject your dose of teduglutide under the skin (subcutaneous injection) in your stomach area (abdomen), upper legs (thighs), or upper arms. Do not inject teduglutide into a vein or muscle.
• Use a different injection site each time you use teduglutide.
• Teduglutide 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.
• Teduglutide 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 teduglutide.

Your healthcare provider will determine the best teduglutide dose for you based on your body weight. Take teduglutide as directed. Follow the instructions carefully.

The recommended daily dose of teduglutide is 0.05 mg/kg body weight administered by subcutaneous injection once daily.

The recommended daily dose of teduglutide is reduced in patients with kidney disease.

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

Store teduglutide powder at room temperature up to 25°C (77°F).

• Do not freeze teduglutide.
• Use the teduglutide powder by the expiration date on the "Use By" sticker on the kit. Use teduglutide within 3 hours after mixing it.
• Throw away any unused teduglutide that has been mixed, even if there is medicine left in the vial.
• Do not store any teduglutide you have mixed.

Keep teduglutide and all medicines out of the reach of children.