Teduglutide

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

Usage of Teduglutide

Teduglutide is used to treat short bowel syndrome in adults and children at least 1 year old who Depend on intravenous (parenteral) feeding to receive nutrition.

Teduglutide may also be used for purposes not listed in this medication guide.

Teduglutide side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Teduglutide may cause serious side effects. Call your doctor at once if you have:

severe constipation or stomach cramps, nausea, vomiting;

swelling in your hands and feet, rapid weight gain, feeling short of breath;

a change in your stools (bowel movements);

severe pain in your upper stomach spreading to your back;

fever, chills; or

dark urine or yellowing of your skin or eyes.

Common side effects of teduglutide may include:

an allergic reaction;

stomach pain or swelling;

nausea, vomiting;

cold or flu symptoms;

swelling in your hands or feet; 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.

Before taking Teduglutide

Talk with your doctor about the risks and benefits of this medicine.

Teduglutide can cause any abnormal cells in your body to grow faster. Some abnormal cells could become cancerous, increasing your risk of cancer of the liver, gallbladder, pancreas, or intestines. Ask your doctor about your specific risk.

Teduglutide may also increase your risk of polyps in your colon (large intestine). You will need a colonoscopy before and during treatment with teduglutide.

Tell your doctor if you have ever had:

cancer;

polyps in your intestines or rectum;

a blockage in your digestive tract (stomach or intestines), a colostomy or ileostomy;

heart problems, high blood pressure;

kidney disease; or

problems with your gallbladder or pancreas.

Short bowel syndrome can increase your risk of malnutrition during pregnancy. This could lead to premature delivery, low birth weight, birth defects, or other complications in both mother and baby. Follow your doctor's instructions about using this medicine if you are pregnant.

You should not breastfeed while using this medicine.

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How to use Teduglutide

Usual Adult Dose for Short Bowel Syndrome:

0.05 mg/kg via suBCutaneous injection once a dayComments:-Injection sites should be alternated, and may include the thighs, arms, and abdominal quadrants.-IV and IM administration should be avoided.-Missed doses should be taken as soon as possible on that day; patients should not take 2 doses on the same day.Use: Treatment of patients with short bowel syndrome (SBS) who are dependent on parenteral support

Usual Pediatric Dose for Short Bowel Syndrome:

1 year and older: 0.05 mg/kg via subcutaneous injection once a dayComments:-Injection sites should be alternated, and may include the thighs, arms, and abdominal quadrants.-IV and IM administration should be avoided.-Missed doses should be taken as soon as possible on that day; patients should not take 2 doses on the same day.-The manufacturer recommends against use of the 5 mg kit in patients weighing less than 10 kg.-Self-administration has not been studied in pediatric patients.Use: Treatment of patients with SBS who are dependent on parenteral support

Warnings

Teduglutide may increase your risk of colon polyps (in your large intestine). You will need a colonoscopy before and during treatment with teduglutide. Teduglutide may also increase your risk of certain types of cancer. Talk with your doctor about the risks and benefits of teduglutide.

Call your doctor at once if you have severe constipation, stomach cramps, fever, chills, nausea, vomiting, dark urine, or yellowing of your skin or eyes.

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 your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

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