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.
• Your doctor may want you to have certain blood tests and imaging procedures of your colon and bowel done within 6 months before starting treatment, at the end of 1 year of treatment, and at least every 5 years to check for polyps.
• To prepare the medicine using 1 vial and 1 syringe:
  • Hold the diluent syringe by the barrel. Snap off the white cap. Only the top portion of the white cap should be snapped off. Throw the cap away.
  • Push the open end of the needle onto the end of the diluent syringe. Twist the needle clockwise until it stops turning.
  • Remove the green cap from the vial and throw it away. Find the gray rubber seal on top of the vial. Wipe the rubber seal of the vial with an alcohol swab pad to clean it.
  • Remove the plastic cap from the diluent syringe. Hold the vial between your thumb and index finger. Push the needle down though the center of the gray rubber seal. Slowly push down on the plunger of the diluent syringe. Leave the needle and the diluent syringe in place.
  • Gently tap the barrel of the syringe to make sure all diluent has gone into the vial. Remove the syringe from the vial. Let the vial sit for about 30 seconds. Do not put the needle cap back on.
  • Gently roll the vial between the palms of your hands for about 15 seconds. Do not shake the vial. Let it sit for about 2 minutes.
  • After 2 minutes, check the liquid in the vial. It should be clear and colorless to pale yellow, and should not have any particles in it. If there is any powder in the vial that did not dissolve, gently roll the vial for another 15 seconds.
  • Remove the plastic dosing syringe from the package. Carefully pull back on the plunger to the line that matches the dose prescribed by your doctor.
  • Use one hand to hold the vial. Using your other hand, insert the needle straight down into the middle of the gray rubber seal. Gently push down the plunger until all of the air is gone. Turn the vial and syringe upside down.
  • Hold the vial with one hand. Slowly pull back the plunger of the syringe with your other hand. If there are air bubbles, gently tap the side of the syringe so the bubbles rise to the top.
  • Slowly push the plunger up until all air bubbles are out of the syringe. Make sure the tip of the needle is in the fluid in the vial. Slowly pull back the plunger again to draw up the right dose and check for air bubbles. Once there are no more air bubbles, remove the syringe from the vial. Be careful not to touch the needle.
  • Clean the skin with an alcohol swab pad. Gently pinch the skin. Insert the needle into the skin at a 45 degree angle with a quick, "dart-like" motion. Slowly push down the plunger until the syringe is empty.
• 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. Use the mixed solution within 3 hours. 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 or any oral medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have kidney disease, cancer, congestive heart failure, heart or blood vessel disease, high blood pressure, gallbladder disease, bowel problems (including polyps), or pancreas problems.
• Do not breastfeed during treatment with this medicine.
• This medicine may cause the following problems:
  • Increased risk for tumor and tumor growth
  • Stomach or bowel blockage
  • Pancreatitis (swelling of the pancreas)
  • Gallbladder problems, including cholangitis, cholecystitis, cholelithiasis
  • Fluid retention (extra water in the body)
• 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