Revestive (Subcutaneous)

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.

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

If you experience abdominal or stomach pain, severe constipation, nausea, 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 risk is higher if you have active cancer in your gut, liver, or pancreas. Talk to your doctor if you have concerns.

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

In deciding to use a medicine, you and your doctor need to think about the risks and benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been done to determine the effects of teduglutide injection in children younger than 1 year. Safety and effectiveness have not been confirmed.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the use of teduglutide injection. However, older patients may be more sensitive to the effects of this medicine compared to younger adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the possible risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others may be combined even if interactions could happen. In such cases, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtimes or with specific types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how this medicine works. Make sure to tell your doctor if you have any other medical conditions, especially:

• Bowel blockage or
• Colon polyp (abnormal growth in the colon)—This should be treated or removed before starting this medicine.

• Cancer (in the 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 issues—Use with caution. This may worsen these conditions.

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

• Severe liver disease—The use of this medicine has not been studied in these patients.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all side effects may occur, but if they do, they may require 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 require medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you how to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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.

In the U.S.

• Gattex
• Revestive

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Gastrointestinal Agent

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.