Patient Medication Information: uses, side effects, how to take - Immucyst
ABOUT THIS MEDICATION
What the medication is used for:
ImmuCyst® is used to treat cancerous growths (tumours) on the surface of the bladder. ImmuCyst® also prevents the growth of new tumours.
What it does:
ImmuCyst® works by stimulating your body’s immune system to fight against bladder tumours. This form of treatment is called immunotherapy. Research has shown that immunotherapy is a more effective treatment than chemotherapy in fighting the growth of bladder tumours.
When it should not be used:
- If you get a bacterial urinary tract infection (UTI) while you are taking ImmuCyst® or if you have large amounts of blood in your urine, your doctor may stop the treatment.
The effects of ImmuCyst® on pregnancy are not known. Female patients should use birth control while on ImmuCyst®. Tell your doctor immediately if you think you may be pregnant.
- Women should not breastfeed while on ImmuCyst®.
- Do not use ImmuCyst® if you are allergic to any ingredient in the product.
- People who have active tuberculosis (TB) should not have this treatment.
- People who have any form of immune deficiency should not have this treatment. Immune deficiency may result from diseases (such as AIDS, leukemia and lymphoma) or from treatments that suppress the immune system (such as corticosteroid or cancer therapy that includes cytotoxic drugs or radiation).
- If you have a bladder operation, you should wait a minimum of 14 days before starting to take ImmuCyst®.
What the medicinal ingredient is:
ImmuCyst® is a freeze-dried preparation made from weakened bacteria called Mycobacterium bovis. The BCG organisms are alive but weakened.
What the important non-medicinal ingredients are:
Monosodium glutamate: 150 mg
For a full listing of non-medicinal ingredients see Part 1 of the Product Monograph.
What dosage forms it comes in:
Each vial contains 81 mg (dry weight) of BCG powder. The powder must be mixed with saline. A health-care provider will give you the medication through a catheter (a tube) inserted into your bladder.
Serious Warnings and Precautions
Systemic BCG Reactions A systemic BCG reaction is a general body illness caused by spread of BCG beyond the bladder or an unusual reaction of your body to BCG within your bladder. This reaction is rare but may occur after ImmuCyst® treatment. Contact your doctor if you have any of the following symptoms, after having an ImmuCyst® treatment:
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WARNINGS AND PRECAUTIONS
Before you use ImmuCyst® talk to your doctor or pharmacist if you:
- have blood in your urine or a urinary tract infection,
- have had a treatment or a disease (such as AIDS) that weakens your immune system,
- have had radiation therapy for cancer,
- are pregnant, breast feeding or intending to become pregnant during therapy,
- have a major medical or surgical procedure scheduled during or shortly after ImmuCyst® treatment,
- have any allergies to the ingredients in ImmuCyst®.
INTERACTIONS WITH THIS MEDICATION
Treatment using immunosuppressants and/or radiation interfere with the body’s response to ImmuCyst®. They also increase the risk of side effects from the medication.
Antibiotic therapy used for other infections may interfere with the effectiveness of ImmuCyst®.
Treatment with ImmuCyst® may cause a positive tuberculosis skin test. The results of a skin test for tuberculosis any time after treatment with ImmuCyst® may show that you have tuberculosis even if you don’t. If you need a TB skin test, it should be done before you start treatment with ImmuCyst®.
PROPER USE OF THIS MEDICATION
Before Your Treatment
- Tell your doctor about any medications you take regularly. Certain drugs affect how ImmuCyst® works (e.g., some antibiotics, medications that may suppress your bone marrow or immune system and/or radiation).
- Do not drink fluids for at least 2 hours before your treatment so that your bladder will be empty.
- You will have to go to your doctor’s office or the hospital for treatment with ImmuCyst®. The treatment does not take a long time, but you should take the day off because of the things you need to do after your treatment.
Things to Know About Your Treatment
When will you have it?
IMPORTANT: PLEASE READ BEFORE TAKING THIS MEDICATION
- Your treatment should begin about 2 weeks after biopsy or transurethral resection.
- For the first course of treatment, you will get one dose of ImmuCyst® into your bladder once-a-week for 6 weeks.
- If your doctor prescribes maintenance treatments, you will continue with one dose per week for 3 weeks after six weeks have gone by since you completed your first course of treatment. After six months have passed since you began your first course of treatment, you will have one dose per week for 1 to 3 weeks every 6 months. Your doctor will decide how long you will need maintenance treatment.
What will they do?
- Your doctor or nurse will place a catheter (tube) into your bladder. If there is any urine in your bladder it will be drained through the catheter.
- The doctor or nurse will attach a container of ImmuCyst® solution to the catheter. The solution will run into your bladder. This process is called instillation.
- When all the solution is in your bladder, the catheter will be removed.
What do you have to do?
- Be sure to lie on your stomach for the first 15 minutes after the catheter is removed. After that, you can get up and move around. This will make sure ImmuCyst® has completely covered the inside of your bladder.
- You must hold the ImmuCyst® inside your bladder for as long as possible, up to 2 hours. After 2 hours, you can empty your bladder.
After Your Treatment
- Unless your doctor tells you not to, you should drink lots of liquids for the next 24 hours. Try to drink at least twelve 250 mL (8 oz.) glasses of liquid per day. Urinate frequently.
- Because ImmuCyst® may be infectious; you should disinfect the urine in the toilet before you flush. To do this, pour one cup of pure undiluted bleach into the toilet bowl every time you urinate. Leave bleach in the toilet bowl for 15 minutes before flushing. You should do this every time you urinate for the first 6 hours after treatment.
Overdose:
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Some people have unpleasant side effects during their treatment with ImmuCyst®. However, the side effects are usually easy to manage. On your treatment days, they may be worse but they will get better in a few days. It is important for you to stay on ImmuCyst® for the whole treatment time. Completing the treatment helps to prevent the tumour from coming back.
Please talk to your doctor about any side effects that you feel may prevent you from finishing the treatment.
The most common side effects include:
- flu-like symptoms: fever, chills, headaches, and muscle aches
- frequent or painful urination
- urination at night
- traces of blood in your urine.
To help you manage these side effects, get plenty of bed rest, drink lots of liquids and take acetaminophen or ASA for any pain and fever. If you are concerned about your symptoms, contact your doctor.
This is not a complete list of side effects. Contact your doctor or pharmacist if you have any unexpected side effects while taking ImmuCyst®.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
If you experience the following symptoms, contact your doctor or get emergency help immediately:
- any sign of an ALLERGIC REACTION, which includes difficulty breathing, shortness of breath, wheezing, rash or hives and/or swelling of the face, or
- any sign of a BCG INFECTION which includes cough, high fever for more than 12 hours (greater than 39.5°C) or a fever (greater than 38.5°C) which lasts longer than two days. Please Note: BCG infection can occur months or years after treatment
If you notice the following symptoms, please see your doctor as soon as possible:
- yellow eyes or skin
- white or grey-coloured stools
- fever with chills, headache, muscle or joint pain that is not relieved by acetaminophen or ASA and lasts for more than 2 days
- severe pain or excessive urinating
- eye problems
- blood in urine
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by: toll-free telephone: 866-234-2345 toll-free fax: 866-678-6789 By email: cadrmp@hc-sd.gc.ca By regular mail: National AR Centre Marketed Health Products Safety and Effectiveness Information Division Marketed Health Products Directorate Tunney’s Pasture, AL 0701C Ottawa, ON K1A 0K9 NOTE: Before contacting Health Canada, you should contact your physician or pharmacist. |
HOW TO STORE IT
ImmuCyst® should be stored at 2º to 8ºC by your health-care provider.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals, can be found at: www.sanofipasteur.ca or by contacting the sponsor,
Sanofi Pasteur Limited
1755 Steeles Avenue West
Toronto, Ontario, M2R 3T4
Phone: 1-888-621-1146 (no charge) or 416-667-2779. Business hours: 7:30 a.m. to 7:30 p.m. Eastern Time Monday to Friday.
Last revised: June 2015
R14-0615 Canada