Consumer Medicine Information
What is in this leaflet
Please read this leaflet before you start using REVESTIVE.
This leaflet answers some common questions about REVESTIVE. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you using REVESTIVE against the benefits they expect it will have for you.
If you have any concerns about using this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What REVESTIVE is used for
REVESTIVE is used to treat adults with Short Bowel Syndrome. Short Bowel Syndrome is a disorder arising from an inability to absorb food nutrients and fluid across the gastrointestinal tract (gut). It is often caused by surgical removal of all or part of the small intestine.
REVESTIVE contains the active substance teduglutide. It improves the absorption of nutrients and fluid from your remaining gut.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
This medicine is not addictive.
This medicine is available only with a doctor's prescription.
Before you use REVESTIVE
When you must not use it
Do not use REVESTIVE if you have an allergy to:
any medicine containing teduglutide
any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Do not use REVESTIVE if you:
have cancer in the gastrointestinal tract, liver, gallbladder, bile ducts or pancreas
have had cancer in the gastrointestinal tract, including liver, gallbladder, bile ducts or pancreas, within the last five years.
Do not give this medicine to a person below 18 years of age.
The benefits and risks in children or adolescents below 18 years of age have not been established.
Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start using this medicine, talk to your doctor.
Before you start to use it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
severely decreased liver function
certain cardiovascular diseases (affecting the heart and/or blood vessels), such as high blood pressure or a weak heart. The symptoms include sudden weight gain, swollen ankles and/or shortness of breath
decreased kidney function
other severe diseases that are not well controlled.
Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.
Your doctor can discuss with you the risks and benefits involved.
Medical check-ups before and during treatment
Before you start treatment with this medicine, your doctor will need to perform a colonoscopy (a procedure to see inside your colon and rectum) to check for the presence of polyps (small abnormal growths) and remove them. It is recommended that your doctor performs these examinations once a year during the first two years after starting treatment, and then at a minimum of five-year intervals. If polyps are found either before or during your treatment with REVESTIVE, your doctor will decide whether you should continue using this medicine.
REVESTIVE should not be used if a cancer is detected during your colonoscopy.
If you have not told your doctor about any of the above, tell him/her before you start using REVESTIVE.
Taking other medicines
Tell your doctor or pharmacist if you are using any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
REVESTIVE may affect how other medicines are absorbed from the gut and therefore how well they work. Your doctor may have to change your dose of other medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while using this medicine.
How to use REVESTIVE
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor, pharmacist or nurse for help.
How much to use
The recommended daily dose is 0.05 mg per kg body weight once per day, given under the skin. The dose will be prescribed as mL of solution.
Your doctor will choose the dose that is right for you depending on your body weight. Your doctor will tell you which dose to inject. If you are not sure, ask your doctor, pharmacist or nurse.
How to use it
REVESTIVE is injected under the skin (subcutaneously) once daily.
The injection can be self-administered or given by another person, for example your doctor, his/her assistant or your home nurse.
If you are injecting the medicine yourself, you must receive adequate training by your doctor or nurse. You will find detailed instructions for injections at the end of this leaflet.
How long to use it
Continue using this medicine for as long as your doctor prescribes it for you.
Do not stop using this medicine without consulting your doctor, as a sudden stop can cause changes in your fluid balance.
If you forget to use it
If you forget to inject this medicine (or cannot inject it at your usual time), use it as soon as possible on that day.
Never use more than one injection in the same day.
Do not inject a double dose to make up for the dose that you missed.
If you have trouble remembering to use your medicine, ask your pharmacist or nurse for some hints.
If you use too much (overdose)
Immediately telephone your doctor or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have used too much REVESTIVE. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
While you are using REVESTIVE
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using REVESTIVE.
Tell any other doctors, dentists, and pharmacists who treat you that you are using this medicine.
If you become pregnant while using this medicine, tell your doctor immediately.
Keep all of your doctor's appointments so that your progress can be checked.
It is recommended that your doctor performs examinations to check for the presences of polyps once a year during the first two years after starting treatment, and then at a minimum of five-year intervals. (See 'Medical check-ups before and during treatment' in 'Before you use REVESTIVE' section).
Your doctor will take special care and monitor your small bowel function and monitor for signs and symptoms indicating problems with your gallbladder, bile ducts and pancreas.
Things you must not do
Do not use REVESTIVE to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.
Do not stop using your medicine or lower the dosage without checking with your doctor.
If you stop using it suddenly, your fluid balance may change.
Things to be careful of
Be careful driving or operating machinery until you know how REVESTIVE affects you.
This medicine may cause you to feel dizzy. If this happens to you, do not drive or use machines until feel better.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using REVESTIVE.
Like all medicines, REVESTIVE can cause some side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
cold or flu-like symptoms
polyps (small abnormal growths) in your large bowel
swelling of stoma (an artificial opening for waste removal)
urinary tract infection
reddening, pain or swelling at the site of the injection
The above list includes the more common side effects of your medicine. They are usually mild and short-lived.
Tell your doctor as soon as possible if you notice any of the following:
swelling of hands and/or feet
any infection of the sinuses, throat, airways or lungs (respiratory tract infection)
tiredness, shortness of breath, with or without swelling of ankles or legs (congestive heart failure)
The above list includes serious side effects that may require medical attention. Serious side effects are rare.
Contact your doctor or go to the emergency unit immediately if any of the following occurs:
allergic reaction which may result in a rash or more rarely to a sharp drop in blood pressure, difficulty breathing, and hives/itching (anaphylactic reaction)
severe stomach ache, fever (inflammation of the pancreas)
severe stomach ache, vomiting, constipation (blockage of the bowel)
yellowing of the skin and the whites in the eyes, itching, dark urine and light-coloured stools or pain in the upper right side or middle of the stomach area (reduced flow of bile from the gallbladder and/or inflammation of the gallbladder)
Tell your doctor, pharmacist or nurse if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.
After using REVESTIVE
Keep your medicine in the pack until it is time to take it.
If you take the medicine out of the pack it may not keep well.
Keep the medicine in a cool dry place where the temperature stays below 25°C. Do not freeze.
After reconstitution, the solution should be used immediately. However, chemical and physical stability has been demonstrated for 3 hours at 25°C.
Do not store REVESTIVE or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
If your doctor tells you to stop using this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
What REVESTIVE looks like
REVESTIVE is a powder and solvent for solution for injection (5 mg powder in vial, 0.5 mL solvent in pre-filled syringe). The powder is white and the solvent is clear and colourless.
One vial of powder contains 5 mg of teduglutide. After reconstitution, each vial contains 5 mg teduglutide in 0.5 mL of solution, corresponding to a concentration of 10 mg/mL.
Each pack contains 28 powder vials, 28 pre-filled syringes with solvent, and 6 plungers.
REVESTIVE contains teduglutide as the active ingredient.
monobasic sodium phosphate monohydrate
dibasic sodium phosphate heptahydrate
The solvent is sterile water for injections.