Gattex
Pronunciation: Ga-tex
Generic name: teduglutide
Dosage form: vial for subcutaneous injection (5 mg)
Drug class: Miscellaneous GI agents
What is Gattex? Short Bowel Syndrome Treatment
Gattex is used to treat Short Bowel Syndrome (SBS) in adults and children aged 1 year and older who require additional parenteral nutrition support (IV feeding). It is administered as a subcutaneous injection once a day.
Key Facts About Gattex:
- Use: Short Bowel Syndrome (SBS)
- Generic Name: teduglutide
- FDA Approval Date: December 21, 2012
- Generic Availability: No generic version available
- Administration: Daily subcutaneous injection
- Patient Population: Adults and pediatric patients 1+ years with SBS
How does Gattex work? Mechanism of Teduglutide
Gattex (teduglutide) works by increasing levels of glucagon-like peptide-2 (GLP-2), a naturally occurring protein essential for:
- Promoting intestinal cell function and growth
- Maintaining stomach and intestinal health
- Supporting digestive tract repair.
In patients with Short Bowel Syndrome, GLP-2 levels are typically low. Gattex provides a synthetic version of this critical protein and belongs to the drug class called GLP-2 analogs.
Gattex Side Effects
Common Side Effects
The most common side effects of Gattex are:
- Gastrointestinal: Abdominal pain, bloating, nausea, vomiting
- Respiratory: Upper respiratory tract infections
- Injection site: Skin reactions at the injection site
- Other: Fluid overload, edema, hypersensitivity reactions
Side effects in children are similar to those observed in adults.
Tell your healthcare provider if you have any side effects that bother you or do 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.
Serious Side Effects and Warnings
Cancer Risk and Abnormal Cell Growth
Gattex may accelerate the growth of existing abnormal cells. There is an increased risk of these abnormal cells becoming cancerous. If you get cancer of the bowel (intestines), liver, gallbladder, or pancreas while using Gattex, your healthcare provider should stop Gattex. If you get other types of cancers, you and your healthcare provider should discuss the risks and benefits of using Gattex. Regular monitoring is required.
Intestinal Polyps
Polyps are growths on the inside of the intestines.
Adults: Colonoscopy required within 6 months before starting Gattex, then after 1 year, then every 5 years minimum.
Children: Stool blood testing within 6 months before starting, then annually. If blood is found in the stool, your child's colon and upper intestine will be checked for polyps, and any found will be removed.
Bowel Obstruction
A bowel obstruction occurs when your bowel becomes blocked, preventing food, fluids, and gas from moving through the bowels in the normal way. Tell your healthcare provider right away if you have any of these symptoms of a bowel or stoma blockage:
- Difficulty with bowel movements or passing gas
- Vomiting, nausea, or abdominal pain
- Stoma blockage (if applicable).
Gallbladder and Pancreas Complications
Swelling (inflammation) or blockage of your gallbladder or pancreas can occur. Your healthcare provider will check your gallbladder and pancreas before starting Gattex and at least every 6 months while you are receiving it. Tell your healthcare provider right away if you get abdominal pain, nausea, fever, or jaundice.
Fluid Overload and Heart Failure Risk
Your healthcare provider will monitor you for fluid retention (edema). Excess body fluid may lead to heart failure, especially if you have heart problems. Tell your healthcare provider right away if you get swelling in your feet and ankles, if you gain weight very quickly (water weight), or if you have trouble breathing.
Allergic Reactions
There is a risk of allergic reactions with Gattex. Get emergency medical help if you have signs of an allergic reaction, such as hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.
Drug Interactions
Gattex can make it easier for medications, such as benzodiazepines and others, to be absorbed. A dosage reduction of the other medication may be needed. Tell each of your healthcare providers about all medicines you use now and any medicine you start or stop using.
Safety In Infants
It is not known if Gattex is safe and effective in children under 1 year of age.
Related/similar drugs
Before taking
Do not use this medicine if you are allergic to teduglutide, Gattex, or if you have cancer of the stomach, intestines, liver, gallbladder, or pancreas.
Before using Gattex, tell your doctor about all your medical conditions, including if you:
-
have cancer
-
have polyps in your intestines or rectum
-
have a blockage in your digestive tract (stomach or intestines), a colostomy or ileostomy
-
have heart problems, high blood pressure
-
have kidney disease
-
have problems with your gallbladder or pancreas
- are pregnant or intend to become pregnant
- are breastfeeding.
Pregnancy
It is not known if Gattex will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while using this medicine.
Breastfeeding
It is not known if Gattex passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using this medicine. Breastfeeding is not recommended during treatment with Gattex.
How is Gattex administered?
Use Gattex exactly as your healthcare provider tells you to.
- Your healthcare provider or nurse should show you how to prepare, measure your dose, and give your injection of Gattex.
- Gattex is for adult self-administration or caregiver administration.
- Self-administration in children has not been tested and is not recommended in children.
- Use of the Gattex 5 mg kit is not recommended in pediatric patients weighing less than 22 pounds (10 kg).
Gattex is given 1 time each day at the same time.
- Inject the dose of Gattex under the skin (subcutaneous injection) in your stomach area (abdomen), upper legs (thighs), or upper arms. Do not inject Gattex into a vein or muscle.
- Use a different injection site each time you use Gattex.
- Gattex comes as a powder for injection in a vial that is used only 1 time (single-dose vial). The powder must be mixed with Sterile Water for Injection (a diluent) provided in a prefilled syringe before you inject it.
- Gattex must be injected within 3 hours after you mix it with the diluent.
Do not stop taking Gattex without consulting your healthcare provider.
Read the Instructions for Use for detailed instructions for preparing and injecting a dose of Gattex.
Dosing information
Usual Dose of Gattex for Short Bowel Syndrome (SBS)
- Adults and children: 0.05 mg/kg once daily via subcutaneous injection.
- Renal Impairment: Reduce dosage to 0.025 mg/kg once daily for moderate-to-severe kidney disease.
Alternate injection sites between 1 of the 4 quadrants of the abdomen, or into alternating thighs or alternating arms.
What happens if I miss a dose?
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 normally take it. Do not take 2 doses on the same day.
What happens if I overdose?
If you use more than 1 dose, call your healthcare provider right away.
What should I avoid while using Gattex?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What other drugs will affect Gattex?
Tell your healthcare providers about all the medicines you take, including prescription and 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 (medicines taken by mouth) you take while using Gattex because Gattex may improve how much of these medications is absorbed.
Tell the healthcare provider who gives you Gattex 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
Storage
Store Gattex powder at room temperature up to 77°F (25°C).
- Do not freeze.
Use the powder by the expiration date on the “Use By” sticker on the kit.
Use Gattex within 3 hours after mixing it.
- Throw away any unused Gattex that has been mixed, even if there is medicine left in the vial.
- Do not store any that you have mixed.
Keep out of the reach of children.
Gattex ingredients
Active ingredient: teduglutide
Inactive ingredients: dibasic sodium phosphate heptahydrate, L-histidine, mannitol, and monobasic sodium phosphate monohydrate. Sterile Water for Injection is provided as a diluent.
Available as a kit containing 5 mg teduglutide in a single-dose vial supplied with 0.5 mL Sterile Water for Injection in a single-dose prefilled syringe.
Manufacturer
Gattex (teduglutide) is manufactured by Takeda Pharmaceutical Company, which acquired the drug when it purchased Shire Pharmaceuticals in 2019. Before that, Gattex was developed by NPS Pharmaceuticals.
Takeda's global headquarters are located in Tokyo, Japan. The company also maintains significant operational headquarters in the United States, located in Cambridge, Massachusetts.
Frequently Asked Questions About Gattex
How long does Gattex treatment last?
Treatment duration varies by individual response and clinical need. Regular monitoring is essential.
Can Gattex cure Short Bowel Syndrome?
Gattex helps manage SBS symptoms and reduce parenteral nutrition dependence, but is not a cure.
Is Gattex covered by Medicare/insurance?
Coverage varies by plan. Contact your insurance provider or Takeda for assistance programs.
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Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.