IMMUCYST 81 MG POWDER FOR INTRAVESICAL SUSPENSION

Active substance: BACILLUS CALMETTE-GUERIN CONNAUGHT STRAIN

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ImmuCyst®
BCG Immunotherapy
81 mg (no diluent)
United Kingdom

PATIENT INFORMATION LEAFLET

®

81 mg
Powder for intravesical suspension
BCG Immunotherapy
Read all of this leaflet carefully before you start receiving this
medicine, because it contains important information for you.
Keep this leaflet.You may need to read it again.
If you have any further questions, ask your doctor or nurse.
If any of the side effects gets serious tell your doctor or nurse.This
includes any possible side effects not listed in this leaflet.
What is in this leaflet
1. What ImmuCyst 81 mg is and what it is used for
2. What you need to know before you are given ImmuCyst 81 mg
3. How ImmuCyst 81 mg is given
4. Possible side effects
5. How to store ImmuCyst 81 mg
6. Contents of the pack and other information
1 WHAT ImmuCyst 81 mg IS AND WHAT IT IS USED FOR

ImmuCyst 81 mg is a specially prepared form of the bacterium that is
used in the BCG (Bacillus Calmette-Guérin) injection that is given to
people to protect them against tuberculosis (TB). However, the use of
ImmuCyst 81 mg has nothing to do with the prevention of TB.
ImmuCyst 81 mg is a medication used for the treatment of certain
cancers that are found on the surface of the urinary bladder wall.
ImmuCyst 81 mg is also used in the prevention of recurrence of some
of these cancers.
When ImmuCyst 81 mg is injected into the bladder it sets off a reaction
in which cells of the immune (defensive) system in the bladder wall
start to destroy surrounding cells including cancerous cells.
2 WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN
ImmuCyst 81 mg

Perforation
Line

You should not be given ImmuCyst 81 mg if:
• you are allergic to BCG or any of the ingredients of this medicine
(listed in section 6);
• you have had bladder surgery or a catheter (tube) inserted in your
bladder which caused bleeding within the past 14 days;
• you have a weakened immune system, from treatment (chemotherapy,
radiation therapy or other), or from disease, including HIV infection;
• you have active TB infection;
• you have any symptom or a history of BCG reaction affecting the
whole body (see Warnings and Precautions);
• you have a high temperature of unknown cause, a urinary tract
infection, or bloody urine. Treatment with ImmuCyst 81 mg will be
delayed until these conditions resolve.
If you know any of the above apply to you, tell your doctor.
Warnings and precautions
Systemic BCG reaction
Talk to your doctor immediately if you experience the
symptoms of a systemic BCG reaction.
A systemic BCG reaction is a serious illness which may rarely occur in
persons who have received BCG. It can cause death.
Based on past clinical experience with BCG given in the bladder, a
systemic BCG reaction can be defined as the presence of any of the
following signs, if no other causes can be found for these signs:
• Fever of at least 39.5˚C for at least 12 hours,
• Fever of at least 38.5˚C for at least 48 hours,
• Pneumonitis (inflammation of the lungs),
• Hepatitis (severe liver illness),
• Bacterial infection in the blood stream,
• Inflammation of other organs (shown by a biopsy),
• Blood clotting problems,
• Difficulty breathing.
If you develop the symptoms of a BCG systemic reaction, your doctor
will refer you to a specialist of infectious diseases.
Other warnings
The stopper of the vial of ImmuCyst 81 mg contains latex, which may
cause allergic reactions.
Some male genital or urinary BCG infections have required surgical
removal of the testes.
Talk to your doctor or nurse before being given any dose of
ImmuCyst 81 mg if:
• you have any artificial joints (e.g. hip replacement)
• you have any surgical implants (e.g. pacemaker fitted or replacement
heart valve)
The following information is intended for healthcare professionals only:

Take special care when using ImmuCyst 81 mg
Precautions
• ImmuCyst 81 mg contains living, attenuated mycobacteria.
• ImmuCyst 81 mg must never be prepared or used in the same room as
medicines for systemic use or by the same persons who apply those.
• Patients receiving ImmuCyst 81 mg treatment must not be treated in
the vicinity of patients with known immunodeficiency.
• Persons with a known immunodeficient condition must not be in
contact with ImmuCyst 81 mg.
• The rubber stopper must not be removed from the vial. If leakage or
oozing occurs, the area contaminated with the vial’s content must be
washed with a 5% hypochlorite solution and then with water.
• All instruments and materials which have been in contact with
ImmuCyst 81 mg should be handled as infectious waste.
• Materials in contact with ImmuCyst 81 mg must be sterilised appropriately
or they have to be eliminated according to the rules for handling
infectious waste.
• Contact of contaminated instruments to urinary tract or the inadvertent
injury of the mucous membrane of the urinary bladder or the urethra must
be avoided during the intravesical administration of ImmuCyst 81 mg.
• The intravesical administration of ImmuCyst 81 mg must not be started
earlier than after 2 to 3 weeks following the performance of TUR.

• you know you have an aneurysm which is a swelling of the wall of an artery
• you have any illness that may require treatment with drugs that weaken your
immune system in the future (such as if you are awaiting an organ transplant)
• you know you have a small bladder as there is a risk of bladder contracture
(narrowing of the outlet of the bladder causing difficulty passing urine) after
treatment with ImmuCyst 81 mg
• you have a urinary tract infection (UTI) which causes the need to urinate
more often than normal and pain whilst urinating, as treatment must stop
until it is treated
• you are to have a diagnostic test for TB (tuberculin skin test) as treatment with
ImmuCyst 81 mg will alter the result. Your doctor may recommend that you
take a tuberculin skin test before starting treatment with ImmuCyst 81 mg
• you get flu-like symptoms (fever, cough, headache, aching muscles and
tiredness) or you get an increase in urinary symptoms (e.g. burning or pain
on urination) lasting more than 48 hours or increase in severity
• you get urinary symptoms (such as urgency, frequency of urination or blood
in urine), joint pain, eye complaints (such as pain, irritation or redness),
cough, skin rash, jaundice (yellow skin and eyes), nausea (feeling sick) or
vomiting (being sick).
Because ImmuCyst 81 mg contains live mycobacteria, excreted urine may
also contain live bacteria. You should take appropriate action to protect
family and close contacts from infection (see “After the administration” in
section 3. HOW ImmuCyst 81 mg IS GIVEN). These measures are especially
important if you are living with, or in close contact to, someone who is
immunocompromised (on chemotherapy for example) as they could get a
BCG infection from you (see above Warnings and Precautions for the
symptoms of this serious condition).
If you have any question relating to the above information, please ask your
doctor or nurse.
Children and adolescents
ImmuCyst 81 mg is not to be given to children.
Other medicines and ImmuCyst 81 mg
Tell your doctor if you are taking, or have recently taken, any other medicines.
This includes medicines obtained without a prescription.
In particular, tell your doctor if you are having any treatments that affect your
immune system. These include:
• Anti-cancer medicines, e.g., methotrexate, ciclophosphamide, doxorubicin.
• Medicines used to suppress rejection of transplants, e.g., ciclosporin.
• Radiation treatment.
Also tell your doctor if you have been or are currently taking antibiotics (including
anti-tuberculosis drugs) as they may affect how ImmuCyst 81 mg works.
Pregnancy and breast feeding
If you are pregnant or breast feeding, think you may be pregnant or are planning
to have a baby, ask your doctor for advice before receiving this medicine.
You should not be given ImmuCyst 81 mg if you are pregnant (or think
you may be), or breast feeding unless your doctor has decided that it is in
your best interests. Your doctor will advise you to take precautions to avoid
becoming pregnant whilst being treated with ImmuCyst 81 mg. If you are
breast feeding, you will be recommended to stop whilst being treated with
ImmuCyst 81 mg.
Driving and using machines
No studies on the effects on the ability to drive or use machines have been
performed.
3 HOW ImmuCyst 81 mg IS GIVEN

ImmuCyst 81 mg is always given by a doctor or nurse.
The recommended course of treatment is:
• one dose of ImmuCyst 81 mg into the bladder once a week for 6 weeks
(total of 6 doses);
• a break from treatment for 6 weeks, then one dose per week for 1 to
3 weeks (total of 1 to 3 doses);
• then, six months after the start of your first treatment course, you will
receive maintenance treatment of one dose per week for 1 to 3 weeks
every 6 months (total of 18 doses);
• up to 27 doses over a 3-year period.
Your doctor will decide how long your maintenance treatment will last.
Mode and route of administration:
This medication is administered into the bladder (intravesical route only):
• Your doctor or nurse will insert a catheter (tube) into your bladder via
the urethra (the passage through which you pass urine). If the bladder
contains urine, it will be emptied through the catheter.
• The doctor or nurse will connect to the catheter a pouch containing the
ImmuCyst 81 mg solution. The solution will flow into your bladder. This
process is called instillation.
• Once the entire solution is in your bladder, the catheter will be removed.
After the administration:
• Lie on your stomach for the first 15 minutes following the removal of
the catheter. You may then get up and move around.This will ensure that
the inside of your bladder is completely covered by ImmuCyst 81 mg.
• Keep ImmuCyst 81 mg inside your bladder for, if possible, 2 hours. You
may feel a burning sensation whilst urinating for the first time following
treatment.
If the doctor considers the catheterisation of the bladder as traumatic (e.g. a
bleeding developed), ImmuCyst 81 mg must not be administered and the treatment
should be postponed by at least 2 weeks.
The treatment should be continued at a later date as if there would not have been
any interruption of the treatment regimen.
Reconstitution of freeze-dried product
DO NOT REMOVE THE RUBBER STOPPER FROM THE VIAL. HANDLE AS
INFECTIOUS MATERIAL
The preparation of the ImmuCyst 81 mg should be done using aseptic technique.
A separate area for the preparation of the ImmuCyst 81 mg suspension is recommended
in order to avoid cross contamination (e.g. in a biocontainment cabinet). The person
responsible for mixing the agent should wear gloves, eye protection, a mask and
gown to avoid inhalation of BCG organisms and inadvertent exposure of broken
skin to BCG organisms.
When handling and reconstituting ImmuCyst 81 mg, care should be taken so as to
avoid needle stick injuries.
ImmuCyst 81 mg should not be handled by persons with an immunologic
deficiency.
ImmuCyst 81 mg is to be reconstituted only with sterile preservative-free normal
saline to ensure proper dispersion of the organisms. For the reconstitution and
further dilution of one dose of ImmuCyst 81 mg, 50 ml of sterile preservative-free
normal saline are required.
Three options for intravesicular administration are possible:
Option 1:
• Using a 5 ml sterile syringe and needle, draw up 3 ml of sterile preservative-free
saline solution.

ImmuCyst®
BCG Immunotherapy
81 mg (no diluent)
United Kingdom

• To lower the chance of contamination from the BCG in your urine you
should urinate in a seated position for six hours following treatment.
• Any urine passed during this time should be disinfected with an equal
volume of household bleach for 15 minutes before flushing or disposal.
• Unless otherwise specified by your doctor, drink plenty of fluids during
the 48 hours following treatment and urinate frequently.
Frequency and duration of treatment
Follow the instructions of your treating doctor closely.
Never interrupt the treatment.
If you have any further questions on the use of this product, ask your doctor
or nurse.
If you think you have been given more ImmuCyst 81 mg than you
should
As ImmuCyst 81 mg is administered by a health-care professional it is most
unlikely that you will be given the wrong dose. If you have any concerns about
your dose or the use of this product speak to your doctor or nurse.
4 POSSIBLE SIDE EFFECTS

Like all medicines ImmuCyst 81 mg can sometimes cause side-effects, although
not everybody gets them.
Some people have unpleasant side effects during their treatment with
ImmuCyst 81 mg. 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 81 mg for the whole treatment time.
Completing the treatment helps to prevent the tumour from coming back.
Talk to your doctor or nurse about any side effects that you feel may prevent
you from finishing the treatment.
If you notice the following side effects, see your doctor immediately:
• BCG infection (see Warning and Precautions for typical symptoms of
the condition) which happens because the BCG bacteria have got into your
blood and could result in the following:
• Serious infections of the blood (septicemia with shock), occasionally fatal
• Infections of the eyes, lungs, liver (shown by an abnormal liver function
test), bones, bone marrow, kidneys, lymph nodes, peritoneum (membrane
lining the abdomen and its organs), testicles (orchitis or epididymitis) and
the prostate (granulomatous prostatitis)
• Infection of an already present aneurysm (a swelling of the wall of an
artery)
• Infection of surgical implants (e.g. replacement heart valve or pacemaker)
or artificial joints (e.g. replacement hip)
• Joint disorders (arthritis or arthralgia), eye disorders (including
conjunctivitis, uveitis, iritis, keratitis, granulomatous chorioretinitis), urinary
disorders (urethritis), skin rash. These symptoms have been reported as
isolated conditions or in combination (Reiter’s syndrome; this is more
likely to happen if you are a carrier of the HLA-B27 tissue antigen).
Side effect information from clinical trials
Very common reactions (affects more than 1 user in 10) are:
• Pain or burning during urination (dysuria), traces of blood in the urine
(haematuria), sudden and unstoppable need to urinate (urinary urgency)
and frequent urge to urinate (urinary frequency)
• Feeling generally unwell (malaise), fever, chills
Common reactions (affects 1 to 10 users in 100) are:
• Urinary tract infection (UTI), bladder inflammation (cystitis), bladder
cramps and pain, inability to hold urine (urinary incontinence) and
difficulty passing urine (bladder contracture)
• Loss of appetite (anorexia), feeling sick (nausea), being sick (vomiting),
diarrhoea
• Liver lesions (hepatic lesions),
• Heart problems (cardiac disorders)
• Skin rash
• Joint pain (arthralgia) and muscle pain (myalgia), inflammation of joints
(arthritis)
• Feeling tired (fatigue)
Uncommon (affects 1 to 10 users in 1,000) are:
• Generalised (systemic) infections, lung (pulmonary) infections, local
infections
• Reduced number of red blood cells (anaemia), insufficient number of
white blood cells in the blood (leukopenia), abnormally low number of
platelets which are the blood components involved in blood clotting
(thrombocytopenia), blood clotting and bleeding disorder (coagulopathy)
• Headaches, dizziness
• Abdominal pain, constipation
• Inflammation of mucous membranes of your mouth or intestinal tract
(mucositis, stomatitis or ulcers)
• Liver disease (granulomatous hepatitis)
• Skin abscess, hypersensitivity skin reaction (causing itchy, inflamed skin
and/or rash)
• Kidney disorders (renal toxicity)
• Urinary obstruction
• Visible skin particles in urine
• Genital pain, flank (side) pain

Other side effects that have occurred in people using
ImmuCyst 81 mg:
• Serious lung disease (pneumonia, interstitial lung disease)
• Purple-reddish lumps on the skin (erythema nodosum)
• Serious kidney disease including:
• renal abscess
• renal insufficiency
• kidney infection (pyelonephritis)
• kidney inflammation (nephritis including tubulointerstitial
nephritis, interstitial nephritis and glomerulonephritis)
• Difficulty in urinating including the presence of blood clots in the
bladder (vesical tamponade) and constant urge to urinate (feeling
of incomplete emptying of the bladder)
• Flu-like symptoms (fever, cough, headache, aching muscles and
tiredness)
• Abnormal blood tests: abnormal or increased blood creatinine or
blood urea nitrogen
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor (GP or
hospital doctor).
5 HOW TO STORE ImmuCyst 81 mg

Keep this medicine out of the sight and reach of children.
The information in section 5 and 6 is primarily for healthcare
professionals.
ImmuCyst 81 mg should be kept in a refrigerator at a temperature
between 2º and 8ºC. Do not use after the expiry date stated on the
vial. The expiry date refers to the last day of that month.
At no time should the freeze-dried or reconstituted ImmuCyst 81 mg
be exposed to sunlight, direct or indirect. Exposure to artificial light
should be kept to a minimum.
Once reconstituted, the product should be used immediately.
The reconstituted product must not be used if any cloudiness or
precipitation (lumps) can be seen in it.
If there is an unavoidable delay between reconstitution and
administration, this delay should not exceed 2 hours at a temperature
between 2° and 25°C.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6 CONTENTS OF THE PACK AND OTHER INFORMATION

What Immucyst 81 mg contains
The active substance(s) is:
Attenuated Mycobacterium bovis suspension*:
81 mg or 1.8 to 15.9 x 108 CFU** per instillation dose when resuspended
* Live Bacillus Calmette-Guérin (Connaught) strain
** Colony Forming Units

The other ingredient is monosodium glutamate. No preservative is
added.
What ImmuCyst 81 mg looks like and contents of pack
ImmuCyst 81 mg is a white powder in a 5 ml glass vial.
ImmuCyst 81 mg comes in packs of 1 vial.
Marketing Authorisation Holder
Alliance Pharmaceuticals Ltd
Avonbridge House
Bath Road
Chippenham
Wiltshire SN15 2BB
Trading as: Cambridge Laboratories, Avonbridge House, Bath Road,
Chippenham, Wiltshire, SN15 2BB, United Kingdom
Manufacturer
Sanofi Pasteur Limited, Toronto, Ontario, Canada
This leaflet was last revised in: March 2013

R3-0313 UK
D54-190CP
0000000-177

Perforation
Line

• Prepare the surface of the ImmuCyst 81 mg vial using a suitable antiseptic.
• Using the same syringe and needle, pierce the rubber stopper in the vial of
freeze-dried material with the needle.
• Holding the vial of freeze-dried material upright, pull the plunger of the syringe
back to the 5 ml marking on the barrel. This will create a mild vacuum in the vial.
• Release the plunger and allow the vacuum to pull the saline from the syringe into
the vial of freeze-dried material.
• After all the saline has passed into the freeze-dried material, remove the needle
and syringe.
• Shake the vial gently until a fine, even suspension results. Avoid foaming since this
will prevent withdrawal of the proper dose. Any reconstituted product, which
exhibits flocculation or clumping that cannot be dispersed with gentle shaking
should not be used.
• Withdraw the entire contents of the reconstituted material from the vial into
the same 5 ml syringe. Return the vial to an upright position before removing the
syringe from the vial.
• Further dilute the reconstituted material from the vial (1 dose) with sterile
preservative-free normal saline to a final volume of 50 ml for intravesical
instillation.
• The reconstituted product is then transferred to a bladder syringe.
Option 2:
Follow instructions as above except the entire contents from the reconstituted vial
is added to a saline bladder irrigation bag instead of a bladder syringe.
Option 3:
Use a 50 ml (closed system) saline bladder irrigation bag to reconstitute
ImmuCyst 81 mg and instill the solution as per the manufacturer’s instructions.

Reconstituted product
The product should be used immediately after reconstitution.
Reconstituted product should not be exposed to direct or indirect sunlight.
Exposure to artificial light should also be kept to a minimum.
If there is an unavoidable delay between reconstitution and administration, this
delay should not exceed 2 hours at a temperature between 2°C and 25°C.
Any reconstituted product that exhibits flocculation or clumping that
cannot be dispersed with gentle shaking should not be used.
Instructions for Disposal
Unused product, packaging, and all equipment and materials used for
instillation of the product (e.g. syringes, catheters) should be placed
immediately in a container for biohazardous materials and disposed of
according to local requirements applicable to biohazardous materials.
Urine voided during the 6-hour period following ImmuCyst 81 mg
instillation should be disinfected with an equal volume of 5% hypochlorite
solution (undiluted household bleach) and allowed to stand for 15 minutes
before flushing.
R3-0313 UK
D54-190CP
0000000-177

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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