Teduglutide

Generic Name: teduglutide (TE-due-GLOO-tide)
Brand Name: Gattex

Teduglutide is used for:

Treating short bowel syndrome (SBS) in patients who receive intravenous (IV) feeding.

Teduglutide is a peptide analog. It works by increasing blood flow to the bowels. This increases the flow of water, electrolytes, and nutrients into the bowels, which reduces the need for IV feeding.

Do NOT use teduglutide if:

  • you are allergic to any ingredient in teduglutide
  • you have liver or gallbladder cancer, stomach or bowel cancer, or pancreatic cancer

Contact your doctor or health care provider right away if any of these apply to you.

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Before using teduglutide:

Some medical conditions may interact with teduglutide. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have kidney problems, liver problems, gallbladder problems, pancreas problems, heart problems (eg, heart failure), or high blood pressure
  • if you have any type of cancer or polyps in your bowel or rectum, or if you have a history of either of these conditions

Some MEDICINES MAY INTERACT with teduglutide. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Benzodiazepines (eg, alprazolam) or phenothiazines (eg, chlorpromazine) because the risk of their side effects may be increased by teduglutide

This may not be a complete list of all interactions that may occur. Ask your health care provider if teduglutide may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use teduglutide:

Use teduglutide as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Teduglutide comes with an extra patient information sheet called a Medication Guide. It also comes with an additional patient leaflet with detailed instructions for use. Read them carefully. Read them again each time you get teduglutide refilled.
  • Teduglutide must be mixed before you inject it. It should be used within 3 hours of mixing. Contact your health care provider if you have any questions about how to mix teduglutide.
  • If there is any powder in the vial that did not dissolve after mixing, gently roll the vial between your hands for 15 seconds. Do not shake teduglutide.
  • Do not use teduglutide if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle or a vein.
  • Be sure to rotate injection sites (eg, thigh, upper arm, stomach) from one injection to the next. Do not inject medicine into skin that is tender, bruised, red, or hard.
  • Teduglutide may affect medicines taken by mouth, which may increase the risk of their side effects. Be sure to tell your doctor about all of the other medicines that you are taking. Contact your doctor with any concerns you might have about taking your other medicines.
  • Throw away any unused medicine that has been mixed, even if the vial is not empty. Do not store for future use.
  • Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of teduglutide, use it as soon as possible that day. If you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses on the same day.

Ask your health care provider any questions you may have about how to use teduglutide.

Important safety information:

  • Teduglutide may make abnormal cells in your body grow faster, which may increase the risk of cancer. Discuss any questions or concerns with your doctor.
  • Lab and/or medical tests may be performed while you use teduglutide. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Teduglutide should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using teduglutide while you are pregnant. It is not known if teduglutide is found in breast milk. Do not breast-feed while taking teduglutide.

Possible side effects of teduglutide:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Appetite changes; cold or flu-like symptoms (eg, cough, runny or stuffy nose, sneezing, sore throat); gas; headache; mild reactions at the injection site; mild stomach pain; nausea; sleeping problems; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in your stools; dark urine; fever or chills; severe or persistent constipation, nausea, vomiting, or stomach or bowel pain; severe or persistent reactions at the injection site (eg, severe rash); shortness of breath; stomach tenderness or swelling; sudden, unexplained weight gain; swelling of the hands, ankles, legs, or feet; swelling or blockage of your stoma opening (if you have a stoma); trouble having a bowel movement or passing gas; unusual bruising or bleeding of the skin; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org ), or emergency room immediately.

Proper storage of teduglutide:

Store teduglutide at room temperature, up to 77 degrees F (25 degrees C). Do not freeze teduglutide. Store away from heat, moisture, and light. Do not store in the bathroom. Use teduglutide by the expiration date on the "Use By" sticker on the kit. Do not store any medicine that has been mixed. Keep teduglutide out of the reach of children and away from pets.

General information:

  • If you have any questions about teduglutide, please talk with your doctor, pharmacist, or other health care provider.
  • Teduglutide is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take teduglutide or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about teduglutide. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to teduglutide. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using teduglutide.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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