Pronunciation:

te-due-GLOO-tide

Brand Names:

• Gattex
• Revestive

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Gastrointestinal Agent

Uses of This Medicine:

Teduglutide injection is used to treat short bowel syndrome (SBS) in patients who are receiving parenteral nutrition. SBS is a condition that prevents the intestine (bowel) or gut from absorbing food properly.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of teduglutide injection in children younger than 1 year of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of teduglutide injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bowel blockage or
• Colon polyp (abnormal growth in the colon)—Should be treated or removed first before using this medicine.

• Cancer (bowels, stomach, liver, pancreas), active or
• Congestive heart failure or
• Electrolyte imbalance or
• Fluid imbalance or
• Gallbladder disease or
• Heart or blood vessel disease or
• Pancreas problems—Use with caution. May make these conditions worse.

• Kidney disease, moderate to severe (eg, end-stage kidney disease)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Liver disease, severe—Use has not been studied in patients with this condition.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. It is given as a shot under your skin, usually in the arms, stomach, or thighs. You or your caregiver may also be trained to prepare and inject this medicine at home. Be sure that you understand how to use the medicine.

Before using this medicine, your doctor may want you to have certain blood tests and imaging procedures (eg, colonoscopy) done within 6 months before and 6 months or 1 year after of treatment.

This medicine should come with a Medication Guide and patient instructions. Read and follow the instructions carefully. Ask your doctor or pharmacist if you have any questions.

If you use this medicine at home, 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. This will help prevent skin problems from the injections. Do not inject into skin areas that are tender, bruised, red, or hard.

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 at least 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. Do not save an open vial.
• Use a new needle and syringe each time you inject your medicine.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (solution):
  • For short bowel syndrome:
    • Adults and children 1 year of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 0.05 milligram (mg) per kilogram (kg) of body weight injected under the skin once a day.
    • Children younger than 1 year of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not shake, freeze, or store the mixed solution. Use it within 3 hours. Throw away any unused medicine after 3 hours.

Throw away used needles in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress regularly while using this medicine to make sure that this medicine is working properly. Blood and urinary tests, colonoscopy, and gallbladder, biliary tract, and pancreas imaging may be needed to check your progress and for any problems caused by this medicine.

If you have abdominal or stomach pain, severe constipation, nausea, or vomiting, or a severe rash after using this medicine, call your doctor right away.

This medicine may increase your risk for tumors and tumor growth. This is more likely if you have an active cancer in your gut, liver, or pancreas. Talk to your doctor if you have concerns.

If you are rapidly gaining weight, having chest pain or discomfort, extreme tiredness or weakness, irregular breathing, uneven heartbeat, or excessive swelling of the hands, wrist, ankles, or feet, check with your doctor immediately. These may be symptoms of heart problems or your body keeping too much water.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Decrease in the amount of urine

excess air or gas in the stomach or bowels

fast heartbeat

fever

full or bloated feeling

hives, itching, skin rash

hoarseness

irritation

joint pain, stiffness, or swelling

noisy, rattling breathing

pressure in the stomach

redness of the skin

stomach pain

swelling of the abdominal or stomach area

swelling of the eyelids, face, lips, hands, or feet

tightness in the chest

troubled breathing at rest

troubled breathing or swallowing

weight gain

Less common

Indigestion

severe nausea or vomiting

Incidence not known

Blurred vision

chest pain or discomfort

dilated neck veins

extreme tiredness or weakness

inability to speak

irregular breathing

irregular heartbeat

loss of consciousness

no blood pressure or pulse

seizures

severe or sudden headache

slurred speech

stopping of the heart

temporary blindness

weakness in the arm or leg on one side of the body, sudden and severe

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Body aches or pain

changes in appetite

chills

cough

ear congestion

headache

loss of voice

nausea

runny or stuffy nose

sneezing

sore throat

trouble sleeping

unusual tiredness or weakness

vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.