Teduglutide injection solution

What is this medicine?

TEDUGLUTIDE (TE due GLOO tide) is used in patients with short bowel syndrome (SBS) who get feedings, nutrition, and fluids by infusion into a vein. It is a hormone that helps the intestine absorb nutrients and fluids from food and drinks. This can help reduce some needs for feedings or fluids by infusion.

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. While this drug may be prescribed for children as young as 1 year of age for selected conditions, precautions do apply.

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

• 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 to your doctor or health care professional if they continue or are bothersome):

• bloating

• gas

• nausea

• pain, redness, or irritation at site where injected

What may interact with this medicine?

• certain medicines for anxiety or sleep

• certain medicines for seizures like carbamazepine, phenytoin

• cyclosporine

• digoxin

• lithium

• quinidine

• sirolimus

• tacrolimus

• theophylline or aminophylline

• warfarin

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.

Where should I keep my medicine?

Keep out of the reach of children.

You will be instructed on how to store this medicine. Store at room temperature up to 25 degrees C (77 degrees F). Do not freeze. Throw away any unused medicine after 90 days.

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

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

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.

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.