Teduglutide Solution for injection

What is this medicine?

TEDUGLUTIDE (TE due GLOO tide) is used in patients with short bowel syndrome (SBS) who get nutrition or fluids from an IV.

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

What should I tell my health care provider before I take this medicine?

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

• cancer

• gallbladder disease

• heart disease

• kidney disease

• pancreatic disease

• polyps in your intestines or rectum

• an unusual or allergic reaction to teduglutide, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection under the skin of your upper leg, stomach area, or upper arm. You will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

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 healthcare provider to get one.

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 pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've 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 that same day. If it is almost time for your next dose, take only that dose. Do not take 2 doses on the same day. Do not take double or extra doses.

What may interact with this medicine?

• certain medicines for anxiety or sleep

• certain medicines for irregular heart beat like digoxin, disopyramide, flecainide, procainamide, quinidine

• certain medicines for seizures like carbamazepine, ethosuximide, phenytoin, valproic acid

• cyclosporine

• levothyroxine

• lithium

• sirolimus

• tacrolimus

• theophylline

• 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 medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

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

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

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

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• dark urine

• general ill feeling or flu-like symptoms

• light-colored stools

• loss of appetite, nausea

• right upper belly pain

• stomach pain

• swelling and blockage of your stoma opening, if you have a stoma

• swelling of the ankles, feet, hands

• trouble having a bowel movement or passing gas

• unusually weak or tired

• vomiting

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• headache

• pain, redness, or irritation at site where injected

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 medicine?

Keep out of the reach of children.

You will be instructed on how to store this medicine. Throw away any unused medicine after the expiration date on the label.

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.