What is the most important information I should know about teduglutide?
You should not use teduglutide if you are allergic to it, or if you have cancer of the stomach, intestines, liver, gallbladder, or pancreas.
Before using teduglutide, tell your doctor if you have heart disease, kidney disease, intestinal polyps, a blockage in your stomach or intestines, a colostomy or ileostomy, or a history of gallbladder or pancrease problems.
Teduglutide can make it easier for your body to absorb any medicines you take by mouth. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
While using teduglutide, you may need frequent blood tests (every 6 months), and then a colonoscopy after 1 year of treatment. If you use this medication long-term, you may need a colonoscopy every 5 years.
This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Stop using teduglutide and call your doctor at once if you have severe constipation or stomach cramps.
What is teduglutide?
Teduglutide is a man-made form of an amino acid that affects the processes of growth and function of cells in the stomach and intestines.
Teduglutide is used to treat short bowel syndrome in adults.
Teduglutide may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before using teduglutide?
You should not use teduglutide if you are allergic to it, or if you have cancer of the stomach, colon, liver, gallbladder, or pancreas.
To make sure teduglutide is safe for you, tell your doctor if you have:
- polyps in your intestines;
- a blockage in your digestive tract (stomach or intestines), a colostomy or ileostomy;
- heart disease;
- kidney disease; or
- a history of gallbladder or pancreas problems.
Your doctor may perform a colonoscopy and other medical tests to make sure you do not have conditions that would prevent you from safely using teduglutide.
Using teduglutide may increase your risk of developing cancer. Ask your doctor about your specific risk.
FDA pregnancy category B. Teduglutide is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
It is not known whether teduglutide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
Do not give this medication to anyone under 18 years old without medical advice.
How is teduglutide given?
Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Teduglutide is injected under the skin. You may be shown how to use injections at home. Do not self inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.
This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Teduglutide is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine. Prepare your dose only when you are ready to give an injection. Mixed medicine must be used within 3 hours.
Use a different place on your stomach, thigh, or upper arm each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row. Do not inject teduglutide into a vein or muscle.
Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.
Use a disposable syringe and needle only once, then throw away in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.
While using teduglutide, you may need frequent blood tests (every 6 months), and then a colonoscopy after 1 year of treatment. If you use this medication long-term, you may need a colonoscopy every 5 years.
Store at room temperature away from moisture and heat. Do not freeze. Throw away any teduglutide not used before the expiration date on the medicine label.
What happens if I miss a dose?
Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using teduglutide?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What are the possible side effects of teduglutide?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using teduglutide and call your doctor at once if you have severe constipation or stomach cramps.
Common side effects may include:
- nausea, vomiting, stomach pain, bloating, gas;
- headache;
- cold symptoms such as stuffy nose, sneezing, sore throat; or
- pain, swelling, redness, or other irritation where the medicine was injected.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect teduglutide?
Teduglutide can make it easier for your body to absorb any medicines you take by mouth, which could increase your blood levels of those medicines or cause unwanted effects. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
Where can I get more information?
Your doctor or pharmacist can provide more information about teduglutide.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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