Teduglutide Injection

(te'' due gloo' tide)

Brand Name(s): Gattex^®

WHY is this medicine prescribed?

Teduglutide injection is used to treat short bowel syndrome in people who need additional nutrition or fluids from intravenous (IV) therapy. Teduglutide injection is in a class of medications called glucagon-like peptide-2 (GLP-2) analogs. It works by improving the absorption of fluids and nutrients in the intestines.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Teduglutide comes as a powder to be mixed with liquid and injected subcutaneously (under the skin). It is usually injected once a day. Inject teduglutide at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Inject teduglutide exactly as directed. Do not inject more or less of it or inject it more often than prescribed by your doctor. If you inject more teduglutide than prescribed by your doctor, call your doctor right away.

Continue to use teduglutide even if you feel well. Do not stop using teduglutide without talking to your doctor.

You may inject teduglutide yourself or have a friend or relative give the injections. You and the person who will be injecting the medication should read the manufacturer's directions for mixing and injecting the medication before you use it for the first time at home. Ask your doctor to show you or the person who will be injecting teduglutide how to mix and inject it.

Teduglutide comes as a kit containing vials of teduglutide powder for injection, prefilled syringes containing diluent (liquid to be mixed with teduglutide powder), needles to attach to the diluent syringe, dosing syringes with needles attached, and alcohol swab pads. Dispose of needles, syringes, and vials in a puncture-resistant container after you use them once. Ask your doctor or pharmacist how to dispose of the puncture-resistant container.

Always look at your teduglutide injection before you inject it. The solution should be clear and colorless or pale yellow, with no particles in it. Teduglutide must be used within 3 hours after mixing teduglutide powder with the diluent.

You can inject your teduglutide in your upper arm, thigh, or stomach. Never inject teduglutide into a vein or muscle. Use a different injection site each day. Do not inject teduglutide into any area that is tender, bruised, red, or hard.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with teduglutide injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.

What SPECIAL PRECAUTIONS should I follow?

Before injecting teduglutide,

• tell your doctor and pharmacist if you are allergic to teduglutide, any other medications, or any of the ingredients in teduglutide injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antihistamines; medications for anxiety and seizures; medications for mental illness and nausea; sedatives; sleeping pills; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have a stoma (a surgically created opening from an area inside the body to the outside, usually in the abdominal area) or if you have or have ever had cancer, polyps in your intestines or rectum, high blood pressure, or gallbladder, heart, kidney, or pancreatic disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking teduglutide, call your doctor.

• you should know that teduglutide injection may cause polyps (growths) in the colon (large intestine). Your doctor will check your colon within 6 months before you start using teduglutide, again right after you have used this medication for 1 year, and then at least once every 5 years. If polyps are found, they will need to be removed. If cancer is found in a polyp, your doctor may tell you to stop using teduglutide injection.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Inject the missed dose as soon as you remember it that day. Inject the next dose the next day at the same time you normally inject it every day. Do not inject two doses on the same day.

What SIDE EFFECTS can this medicine cause?

Teduglutide injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• skin problems at the site of injection
• hives
• rash
• itching
• red spots on the skin
• headache
• gas
• changes in appetite
• difficulty falling asleep or staying asleep
• runny nose
• sneezing
• cough
• flu-like symptoms

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• pain, swelling, or tenderness in the abdomen (stomach area)
• swelling and blockage at the stoma opening (in patients who have a stoma)
• fever
• chills
• change in your stools
• difficulty having a bowel movement or passing gas
• nausea
• vomiting
• dark urine
• yellowing of the skin or eyes
• swelling of the feet or ankles
• rapid weight gain
• difficulty breathing

Teduglutide injection may make abnormal cells in your body grow faster and therefore increase your risk of developing cancer. Talk to your doctor about the risks of taking this medication.

Teduglutide injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not freeze teduglutide. Use the teduglutide powder for injection by the expiration date on the ''Use By'' sticker on the kit.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain procedures and lab tests to check your body's response to teduglutide injection.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: January 15, 2017.