When This Medicine Should Not Be Used:
Do not use this medicine if you have had an allergic reaction to teduglutide.

How to Use This Medicine:
Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin, usually on your upper arms, thighs, or abdomen.
• A nurse or other health provider will give you this medicine. It may also be given by a home health caregiver.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.
• Use a new needle and syringe each time you inject your medicine.
• Do not use if the medicine in the vial has changed color, or if you see particles in it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using a phenothiazine medicine (such as promethazine, Phenergan®, Thorazine®), or a sedative or medicine to help you sleep (such as alprazolam, clonazepam, diazepam, lorazepam, Xanax®).

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, cancer, congestive heart failure, heart or blood vessel disease, gallbladder disease, or a bowel blockage or pancreas problem.
• Check with your doctor right away if you have abdominal pain, severe constipation, nausea or vomiting, or a severe rash after using this medicine.
• Check with your doctor right away if you are rapidly gaining weight, have chest pain or discomfort, extreme tiredness or weakness, trouble breathing, an uneven heartbeat, or excessive swelling of the hands, wrists, ankles, or feet. These may be symptoms of a heart problem or fluid retention.
• Your doctor will need to check your blood at regular visits while you are using this medicine. He may also want to check your colon, gallbladder, and pancreas before you begin treatment and every 6 months during treatment. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Decrease in how much or how often you urinate
• Severe constipation, stomach pain, nausea or vomiting, gas, full or bloated feeling
• Swelling in your hands, ankles, or feet
• Trouble breathing, cold sweat, bluish-colored skin

If you notice these less serious side effects, talk with your doctor:

• Cough, runny or stuffy nose, sore throat
• Pain, itching, burning, swelling, or a lump under your skin where the shot is given
• Trouble sleeping

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088