What Revestive is used for and how to use it
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Revestive - Consumer Medicine Information

Manufacture: Shire, Inc.
Country: Canada
Condition: Short Bowel Syndrome
Class: Miscellaneous GI agents
Form: Subcutaneous (SC), Powder
Ingredients: teduglutide, dibasic sodium phosphate heptahydrate, L-histidine, mannitol, monobasic sodium phosphate monohydrate, sterile water for injection.

teduglutide

What is Revestive 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) due to not enough surface area. It is often caused by surgical removal of all or part of the small intestine.

How Does Revestive Work

REVESTIVE improves the absorption of fluids from your remaining gut by increasing the surface area and function of your remaining gut.

What are the Ingredients in Revestive

Medicinal Ingredients

teduglutide

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.

Non-medicinal Ingredients

dibasic sodium phosphate heptahydrate, L-histidine, mannitol, monobasic sodium phosphate monohydrate. The diluent contains sterile water for injection.

Revestive Comes in the Following Dosage Forms

REVESTIVE is a powder and diluent for solution for injection (5 mg powder in vial, 0.5 mL diluent in pre-filled syringe). Pack size of 28 each.

The powder is white and the diluent is clear and colorless.

Do Not Use Revestive if

  • you are allergic to teduglutide or any of the other ingredients of this medicine;
  • you have or are suspected to have cancer in the gastrointestinal tract, including liver, gallbladder or bile ducts;
  • you have had cancer in the gastrointestinal tract, including liver, gallbladder or bile ducts, within the last five years.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take REVESTIVE. Talk about any health conditions or problems you may have, including if you:

  • have a history of bowel obstruction. Your doctor will consider this when prescribing this medicine.
  • suffer from certain cardiovascular diseases (affecting the heart and/or blood vessels) such as high blood pressure (hypertension) or have a weak heart (cardiac insufficiency). The symptoms include sudden weight gain, swollen ankles and/or shortness of breath. This may require closer monitoring and more frequent changes to the amount of parenteral nutrition/IV fluid that you receive.
  • have decreased kidney function. Your doctor may need to give you a lower dose of this medicine.
  • have severely decreased liver function. Your doctor will consider this when prescribing this medicine.

Medical Check-ups Before and During Treatment With Revestive

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 growths that may be normal or abnormal) and remove them. It is recommended that your doctor performs a follow-up colonoscopy between 1 to 2 years after starting treatment, and then at a minimum of 5 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.

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.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

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.

How to Take Revestive

Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.

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. Do not use the same area each day for each injection. Rotate the site of injection between the upper, lower, left and right side of your belly, either arm or either thigh.

You will find detailed instructions for the preparation, reconstitution and administration of REVESTIVE at the end of this leaflet.

Usual Dose

The recommended daily dose is 0.05 mg per kg body weight. The dose will be given in 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.

Overdose

If you think you have taken too much REVESTIVE, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

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 a forgotten dose.

Keep 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 have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

What are Possible Side Effects From Using Revestive

These are not all the possible side effects you may feel when taking REVESTIVE. If you experience any side effects not listed here, contact your healthcare professional.

Very common (may affect more than 1 in 10 people):

  • Stomach pain
  • Feeling sick (nausea)
  • Bloated stomach
  • Vomiting
  • Respiratory tract infection (any infection of the sinuses, throat, airways or lungs)
  • Swelling of hands and/or feet
  • Reddening, pain or swelling at the site of the injection
  • Swelling of stoma (an artificial opening for waste removal)

Common (may affect up to 1 in 10 people):

  • Flatulence
  • Decreased appetite
  • Problems sleeping
  • Rash (hypersensitivity)
  • Bleeding of the skin
  • Cough

Serious Side Effects and What to Do About Them

Symptom / effectTalk to your healthcare professional in all casesStop taking drug and
get immediate medical
help
Only if severeIn all cases
COMMON
Reduced flow of bile from the gallbladder and/or inflammation of the gallbladder:
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
Congestive heart failure:
Tiredness, shortness of breath or swelling of ankles or legs, sudden weight gain
Intestinal obstruction (blockage of the bowel):
Stomach ache, vomiting
and constipation
Inflammation of the pancreas (pancreatitis):
Stomach ache and fever
UNCOMMON
Fainting:
If heart rate and breathing are not normal and you don`t awaken fast, seek help as soon as possible

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

  • Online at MedEffect;
  • By calling 1-866-234-2345 (toll-free);
  • By completing a Consumer Side Effect Reporting Form and sending it by:
    • Fax to 1-866-678-6789 (toll-free), or
    • Mail to: Canada Vigilance Program
           Health Canada
           Postal Locator 0701E
           Ottawa, ON
           K1A 0K9

    Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

The unopened vials may be stored below 25oC for up to 90 days after dispensing.

Do not freeze.

The product should be used within 3 hours after reconstitution.

Do not use this medicine if you notice that the solution is cloudy or contains particulate matter.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Dispose of all needles and syringes in a sharps disposal container.

Keep out of reach and sight of children.

If you Want More Information About Revestive

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website or by calling 1-844-633-6713.