Teduglutide (te-due-GLOO-tide)

Treats short bowel syndrome (SBS).

Brand Name(s):

Gattex

When This Medicine Should Not Be Used:

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. It is usually injected on your abdomen or stomach, thighs, or upper arms.
• A nurse or other health provider will give you this medicine.
• 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.
• To use this medicine:
  • Inject the water provided in the prefilled syringe into the vial containing the powder.
  • Allow the vial to stand for about 30 seconds and then gently roll it between your palms for about 15 seconds. Do not shake.
  • Allow the mixture to stand for about 2 minutes.
  • Check the vial for any undissolved powder. Gently roll the vial again until all the powder is dissolved. Do not shake. If the product remains undissolved after the second attempt, do not use it.
  • Use the mixture within 3 hours.
  • You might not use all of the medicine in the vial. Use each vial only one time.
• Use a new needle and syringe each time you inject your medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• If you store this medicine at home, keep it at room temperature, away from heat, moisture, and direct light. Do not store any medicine you have mixed. Throw away any unused medicine that has been mixed after 3 hours.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

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

• Some medicines can affect how teduglutide works. Tell your doctor if you are using a benzodiazepine medicine (including alprazolam, clonazepam, diazepam, lorazepam), phenothiazine medicine (including promethazine), or any oral medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, cancer, congestive heart failure, heart or blood vessel disease, gallbladder disease, bowel problems (including polyps), or pancreas problems.
• This medicine may cause the following problems:
  • Increased risk for tumor and tumor growth
  • Stomach or bowel blockage
  • Gallbladder and pancreas problems (including stones, swelling)
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments. Your doctor may also want to check your colon, gallbladder, and pancreas before you begin treatment and at least every 6 months during treatment with this medicine.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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
• Rapid weight gain, swelling in your hands, ankles, or feet
• Severe constipation, sudden and severe stomach pain, nausea, vomiting, gas, full or bloated feeling
• Trouble breathing, cold sweat, bluish-colored skin
• Unusual bleeding, bruising, or weakness

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