Gattex
Pronunciation: Ga-tex
Generic name: teduglutide
Dosage form: Kit for subcutaneous injection (5 mg)
Drug class: Miscellaneous GI agents
What is Gattex?
Gattex is used to treat Short Bowel Syndrome (SBS) in adults and children 1 year and older who need additional nutrition or fluids from intravenous (IV) feeding (parenteral support). It is injected under the skin once a day.
Gattex gained FDA approval on December 21, 2012. There is no generic.
How does Gattex work?
Gattex is a synthetic (man-made) form of glucagon-like peptide-2 (GLP-2). It works by increasing levels of GLP-2, a protein which plays an essential role in promoting cell function and growth in the stomach and intestines. GLP-2 is found in low concentrations in people with SBS.
Side effects
The most common side effects of Gattex are:
- stomach area (abdomen) pain or swelling
- vomiting
- nausea
- swelling of the hands or feet
- cold or flu symptoms
- allergic reactions
- skin reactions where the injection was given.
The side effects of Gattex in children are similar to those seen in adults.
Tell your healthcare provider if you have any side effect that bothers you or does 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
Gattex may cause the following serious side effects:
- Making abnormal cells grow faster. Gattex can make abnormal cells that are already in your body grow faster. There is an increased risk that abnormal cells could become 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.
- Polyps in the intestines. Polyps are growths on the inside of the intestines.
Before you start using Gattex, your healthcare provider will (for Adults):
-
- Have your colon and upper intestines checked for polyps within 6 months before starting Gattex.
- Have any polyps removed.
For children:
-
- Check for blood in the stool within 6 months before starting Gattex.
- If there is blood found in the stool, have your colon and upper intestines checked for polyps.
- Have any polyps removed.
To keep using Gattex, your healthcare provider should (for adults):
-
- Have your colon and upper intestines checked for new polyps at the end of 1 year of using Gattex. 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.
For children
-
- Check for blood in the stool every year while using Gattex.
- If there is blood found in the stool, have your colon and upper intestines checked for polyps.
- Have your colon checked for new polyps at the end of 1 year of using Gattex. 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 Gattex.
- 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 right away if you have any of these symptoms of a bowel or stomal blockage:
- trouble having a bowel movement or passing gas
- vomiting
- stomach area (abdomen) pain or swelling
- swelling and blockage of your stoma opening, if you have a stoma
- nausea
If a blockage is found, your healthcare provider may temporarily stop Gattex.
- 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 Gattex and at least every 6 months while you are using Gattex. Tell your healthcare provider right away if you get:
- stomach area (abdomen) pain and tenderness
- nausea
- chills
- vomiting
- fever
- dark urine
- a change in your stools
- yellowing of your skin or the whites of your eyes.
- 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 right away if you get swelling in your feet and ankles, you gain weight very quickly (water weight), or you have trouble breathing.
Get emergency medical help if you have signs of an allergic reaction to Gattex, such as hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Gattex can make it easier for your body to absorb any medicines you take by mouth. Tell each of your healthcare providers about all medicines you use now and any medicine you start or stop using.
It is not known if GATTEX is safe and effective in children under 1 year of age.
These are not all the side effects of Gattex, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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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.
Self-administration is not recommended in children.
Gattex comes as a 5 mg kit.
- 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 your 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 Adult and Child Dose for Short Bowel Syndrome (SBS): Gattex 0.05 mg/kg once daily via subcutaneous injection.
- Alternate sites between 1 of the 4 quadrants of the abdomen, or into alternating thighs or alternating arms.
Dosage Adjustment for Renal Impairment: Reduce dosage to 0.025 mg/kg once daily in adults and children with moderate and severe renal impairment and end-stage renal disease (estimated glomerular filtration rate less than 60 mL/min/1.73 m2 ).
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.
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.
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.
More about Gattex (teduglutide)
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- Drug class: miscellaneous GI agents
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Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.