Teduglutide

Generic name: teduglutide
Brand name: Gattex
Dosage form: subcutaneous kit (5 mg)
Drug class: Miscellaneous GI agents

Medically reviewed by  A Ras MD.

What is teduglutide used for?

Teduglutide is a prescription medicine that is used to treat short bowel syndrome.

Description

The active ingredient in GATTEX (teduglutide) for injection is teduglutide, which is a 33 amino acid glucagon-like peptide-2 (GLP-2) analog manufactured using a strain of Escherichia coli modified by recombinant DNA technology. The chemical composition of teduglutide is L-histidyl-L-glycyl-L-aspartyl-L-glycyl-L-seryl-L-phenylalanyl-L-seryl-L-aspartyl-L-glutamyl-L-methionyl-L-asparaginyl-L-threonyl-L-isoleucyl-L-leucyl-L-aspartyl-L-asparaginyl-L-leucyl-L-alanyl-L-alanyl-L-arginyl-L-aspartyl-L-phenylalanyl-L-isoleucyl-L-asparaginyl-L-tryptophanyl-L-leucyl-L-isoleucyl-L-glutaminyl-L-threonyl-L-lysyl-L-isoleucyl-L-threonyl-L-aspartic acid. The structural formula is:

Teduglutide has a molecular weight of 3752 Daltons. Teduglutide drug substance is a clear, colorless to light-straw–colored liquid.

Each single-dose vial of GATTEX contains 5 mg of teduglutide as a white lyophilized powder for reconstitution and administration by subcutaneous injection. In addition to the active pharmaceutical ingredient (teduglutide), each vial of GATTEX contains 3.434 mg dibasic sodium phosphate heptahydrate, 3.88 mg L-histidine, 15 mg mannitol, and 0.644 mg monobasic sodium phosphate monohydrate as excipients. No preservatives are present.

At the time of administration, the lyophilized powder is reconstituted with 0.5 mL of Sterile Water for Injection, which is provided in a single-dose prefilled syringe. A 10 mg/mL sterile solution is obtained after reconstitution. Up to 0.38 mL of the reconstituted solution which contains 3.8 mg of teduglutide can be withdrawn for subcutaneous injection upon reconstitution.

Mechanism of Action

Teduglutide is an analog of naturally occurring human glucagon-like peptide-2 (GLP-2), a peptide secreted by L-cells of the distal intestine. GLP-2 is known to increase intestinal and portal blood flow and inhibit gastric acid secretion. Teduglutide binds to the glucagon-like peptide-2 receptors located in intestinal subpopulations of enteroendocrine cells, subepithelial myofibroblasts and enteric neurons of the submucosal and myenteric plexus. Activation of these receptors results in the local release of multiple mediators including insulin-like growth factor (IGF)-1, nitric oxide and keratinocyte growth factor (KGF).

Before taking teduglutide, tell your doctor:

• If you are allergic to teduglutide; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have ever had cancer.
• If you have or have ever had polyps or growths in your bowels or colon.
• If you are breast-feeding. Do not breast-feed while you take teduglutide.

This is not a list of all drugs or health problems that interact with teduglutide.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take teduglutide with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take teduglutide?

• Tell all of your health care providers that you take teduglutide. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• A colonoscopy or other exam will be done before starting teduglutide. These exams will need to be done again as the doctor tells you.
• The chance of cancer is higher after using teduglutide. Talk with the doctor.
• Do not stop taking teduglutide without talking to your doctor. Fluid and electrolyte problems have happened in some people after teduglutide was stopped. Talk with your doctor about what signs to watch for if you will be stopping teduglutide.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using teduglutide while you are pregnant.

How is teduglutide best taken?

Use teduglutide as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the fatty part of the skin on the top of the thigh, belly area, or upper arm.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• This medicine needs to be mixed before use. Follow how to mix as you were told by the doctor.
• Do not shake.
• Move the site where you give the shot with each shot.
• Do not give into tender, bruised, red, or hard skin.
• Do not use if the solution is cloudy, leaking, or has particles.
• This medicine is colorless to a faint yellow. Do not use if the solution changes color.
• Use within 3 hours of making.
• Throw away any part left over after the dose is given.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it on the same day you missed the dose.
• If you do not think about the missed dose until the next day, skip the missed dose and go back to your normal time.
• Do not take 2 doses on the same day.

What are the side effects of teduglutide that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Signs of gallbladder problems like pain in the upper right belly area, right shoulder area, or between the shoulder blades; change in stools; dark urine or yellow skin or eyes; or fever with chills.
• Swelling of belly.
• Severe constipation or stomach pain. These may be signs of a severe bowel problem.
• If you have a stoma, swelling at the stoma site.
• Too much fluid in the body has happened with teduglutide. Sometimes, this can lead to heart failure. Call your doctor right away if you have shortness of breath, a big weight gain, or swelling in the arms or legs.

What are some other side effects of teduglutide?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Gas.
• Upset stomach or throwing up.
• Stomach pain.
• Signs of a common cold.
• Flu-like signs.
• Not hungry.
• Irritation where the shot is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out teduglutide?

• Store at room temperature. Do not freeze.
• Be sure you know how long you can store teduglutide before you need to throw it away.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL – 5 MG VIAL CARTON

• NDC 68875-0101-2
• Rx only
• Gattex®
  (teduglutide) for injection
• 5 mg
• 5 mg per vial.
  For subcutaneous use only.
• Patented: please see https://www.shire.com/legal-notice/product-patents
• GATTEX® is a registered trademark of Shire-NPS Pharmaceuticals, Inc., a Takeda company.
  ©2019 Takeda Pharmaceutical Company Limited. All rights reserved.
• Shire

PRINCIPAL DISPLAY PANEL – SINGLE USE KIT CARTON