Gattex One-Vial

Teduglutide is used by patients with Short Bowel Syndrome (SBS) who need intravenous (IV) nutrition and fluids. It may help to decrease the amount of intravenous nutrition needed by the patient. Teduglutide is similar to a natural hormone in your body (GLP-2). It works by helping to improve intestinal absorption of fluids and nutrients.

Read the Medication Guide and the Instructions For Use Leaflet provided by your pharmacist before you start using teduglutide and each time you get a refill. Learn all preparation and usage instructions. If you have any questions, ask your doctor or pharmacist.

Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Do not shake the vial. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin.

Inject this medication under the skin in the thigh, abdomen, or upper arm as directed by your doctor, usually once daily. The dosage is based on your medical condition, weight, and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.

Decreased appetite, trouble sleeping, cough, flu-like symptoms, or pain/redness/swelling at injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: nausea/vomiting that doesn't stop, swelling ankles/feet, unusual tiredness, sudden weight gain, severe constipation, stomach/abdominal pain or swelling, yellowing eyes/skin, dark urine, black/tarry stool, vomit that looks like coffee grounds.

This medication may increase the risk of cancer. Your doctor will monitor you closely with lab and medical tests. See also Notes section.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using teduglutide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, cancer, gallbladder disease, disease of the pancreas (pancreatitis), intestinal or rectal polyps, heart problems (such as heart failure).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Store at room temperature away from light and moisture. Do not freeze. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

If you miss a dose, use it as soon as you remember if it is on the same day. If it is the next day, skip the missed dose. Use your next dose at the regular time. Do not double the dose or use 2 doses on the same day to catch up.

Do not share this medication with others.

Lab and/or medical tests (such as colonoscopy, fecal occult blood testing, lipase/amylase levels, liver function) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.