Description
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.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
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.
Pediatric
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.
Geriatric
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.
Breastfeeding
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.
Drug Interactions
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 history of or
- Congestive heart failure or
- Electrolyte imbalance or
- Fluid imbalance or
- Gallbladder disease or
- Heart or blood vessel disease or
- Hypertension (high blood pressure) 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
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.
Your doctor may want you to have certain blood tests and imaging procedures of your colon and bowel done within 6 months before starting treatment, at the end of 1 year of treatment, and at least every 5 years to check for polyps.
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 prepare the medicine using 1 vial and 1 syringe:
- Hold the diluent syringe by the barrel. Snap off the white cap. Only the top portion of the white cap should be snapped off. Throw the cap away.
- Push the open end of the needle onto the end of the diluent syringe. Twist the needle clockwise until it stops turning.
- Remove the green cap from the vial and throw it away. Find the gray rubber seal on top of the vial. Wipe the rubber seal of the vial with an alcohol swab pad to clean it.
- Remove the plastic cap from the diluent syringe. Hold the vial between your thumb and index finger. Push the needle down though the center of the gray rubber seal. Slowly push down on the plunger of the diluent syringe. Leave the needle and the diluent syringe in place.
- Gently tap the barrel of the syringe to make sure all diluent has gone into the vial. Remove the syringe from the vial. Let the vial sit for about 30 seconds. Do not put the needle cap back on.
- Gently roll the vial between the palms of your hands for about 15 seconds. Do not shake the vial. Let it sit for about 2 minutes.
- After 2 minutes, check the liquid in the vial. It should be clear and colorless to pale yellow, and should not have any particles in it. If there is any powder in the vial that did not dissolve, gently roll the vial for another 15 seconds.
- Remove the plastic dosing syringe from the package. Carefully pull back on the plunger to the line that matches the dose prescribed by your doctor.
- Use one hand to hold the vial. Using your other hand, insert the needle straight down into the middle of the gray rubber seal. Gently push down the plunger until all of the air is gone. Turn the vial and syringe upside down.
- Hold the vial with one hand. Slowly pull back the plunger of the syringe with your other hand. If there are air bubbles, gently tap the side of the syringe so the bubbles rise to the top.
- Slowly push the plunger up until all air bubbles are out of the syringe. Make sure the tip of the needle is in the fluid in the vial. Slowly pull back the plunger again to draw up the right dose and check for air bubbles. Once there are no more air bubbles, remove the syringe from the vial. Be careful not to touch the needle.
- Clean the skin with an alcohol swab pad. Gently pinch the skin. Insert the needle into the skin at a 45 degree angle with a quick, "dart-like" motion. Slowly push down the plunger until the syringe is empty.
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.
- For short bowel syndrome:
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 freeze. Use the mixed solution 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
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 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.
Check with your doctor right away if you have gaseous stomach pain, indigestion, recurrent fever, severe nausea or vomiting, stomach fullness, or yellow eyes or skin. These may be symptoms of gallbladder problems (eg, cholangitis, cholecystitis, cholelithiasis).
Pancreatitis (swelling of the pancreas) may occur while you are using this medicine. Check with your doctor right away if you have sudden and sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
Check with your doctor right away if you or your child have a decrease in amount of urine, noisy, rattling breathing, swelling of the fingers, hands, feet, or lower legs, or weight gain. These may be symptoms of fluid retention (extra water in the body).
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
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
- Chest tightness
- 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
- trouble 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
- gaseous stomach pain
- inability to speak
- irregular breathing
- irregular heartbeat
- loss of consciousness
- no blood pressure or pulse
- seizures
- severe or sudden headache
- stomach fullness
- stopping of the heart
- slurred speech
- temporary blindness
- weakness in the arm or leg on one side of the body, sudden and severe
- yellow eyes or skin
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.
DRG-20060737
