Teduglutide (Subcutaneous route)
- Powder for Solution
Uses of This Medicine:
Teduglutide injection is used to treat short bowel syndrome (SBS) in adults who are receiving parenteral nutrition. SBS is a condition that prevents the intestine 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:
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.
Appropriate studies have not been performed on the relationship of age to the effects of teduglutide injection in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of teduglutide injection in the elderly.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
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.
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.
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 Should be treated 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
- Pancreatitis Use with caution. May make these conditions worse.
- Kidney disease Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use of This Medicine:
Before using this medicine, your doctor may want you to have certain blood tests and imaging procedures (such as colonoscopy). This should be done within 6 months before and after 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.
This medicine may be given at home by patients who do not need to be in the hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use the medicine.
This medicine is given as a shot under your skin, usually on the upper arms, thighs, or the abdomen (stomach).
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.
Use a new needle and syringe each time you inject your medicine.
Do not use if the medicine in the vial (glass container) has changed color, or if you see particles in it.
Put used needles and syringes in a puncture-resistant disposable container or dispose of them as directed by your doctor. Do not reuse needles and syringes.
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:
- For short bowel syndrome:
- Adults 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 Use and dose must be determined by your doctor.
- For short bowel syndrome:
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.
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 or freeze the mixed solution. Use it within 3 hours.
Precautions While Using This Medicine:
It is very important that your doctor check you regularly while you are using this medicine. This is to make sure that this medicine is working properly. Blood 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.
If you are rapidly gaining weight, having shortness of breath, 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.
Make sure your doctor knows if you are also using a phenothiazine medicine (such as promethazine, Phenergan®, Thorazine®) or a sedative or sleeping medicine (such as alprazolam, clonazepam, diazepam, lorazepam, Xanax®).
Side Effects of This Medicine:
- More common
- Abdominal or stomach pain
- decrease in the amount of urine
- excess air or gas in the stomach or intestines
- fast heartbeat
- full or bloated feeling
- joint pain, stiffness, or swelling
- noisy, rattling breathing
- pressure in the stomach
- redness of the skin
- swelling of the abdominal or stomach area
- swelling of the eyelids, face, lips, hands, or feet
- swelling of the fingers, hands, feet, or lower legs
- tightness in the chest
- troubled breathing at rest
- troubled breathing or swallowing
- weight gain
- Less common
- severe nausea or vomiting
- More common
- Body aches or pain
- changes in appetite
- ear congestion
- loss of voice
- nasal congestion
- runny nose
- sore throat
- trouble sleeping
- unusual tiredness or weakness
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:
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:
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.
Last Updated: 9/15/2016