Teduglutide Injection

What is this medication?

TEDUGLUTIDE (TE due GLOO tide) treats short bowel syndrome (SBS). It works by helping your body absorb more nutrients and fluids from food and drink. This can help reduce the amount of intravenous nutrition needed.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Gattex

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Cancer
• Colon polyps
• Gallbladder disease
• Heart disease
• Kidney disease
• Pancreatic disease
• An unusual or allergic reaction to teduglutide, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is injected under the skin. You will be taught how to prepare and give it. Take it as directed on the prescription label at the same time every day. Keep taking it unless your care team tells you to stop.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or care team to get one.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While this medication may be prescribed for children as young as 1 year of age for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• Certain medications for anxiety or sleep
• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin
• Cyclosporine
• Digoxin
• Lithium
• Quinidine
• Sirolimus
• Tacrolimus
• Theophylline or aminophylline
• Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work done while you are taking this medication.

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancers if you take this medication.

Polyps are growths inside the colon. You must have your colon checked before starting this medication. All polyps must be removed. Your care team will continue to check for polyps after you start your medication.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bowel blockage—stomach cramping, unable to have a bowel movement or pass gas, loss of appetite, vomiting
• Gallbladder problems—severe stomach pain, nausea, vomiting, fever
• Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Bloating
• Nausea
• Pain, redness, or irritation at injection site
• Runny or stuffy nose
• Stomach pain
• Swelling of the ankles, hands, or feet
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature up to 25 degrees C (77 degrees F). Do not freeze. Get rid of any unused medication 90 days after opening.

To get rid of medications that are no longer needed or have expired:

• Take the medications to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If your cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.