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IMMUCYST 81 MG POWDER FOR INTRAVESICAL SUSPENSION

Active substance(s): BACILLUS CALMETTE-GUERIN CONNAUGHT STRAIN / BACILLUS CALMETTE-GUERIN CONNAUGHT STRAIN / BACILLUS CALMETTE-GUERIN CONNAUGHT STRAIN

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ImmuCyst®
BCG Immunotherapy
Dieline D54-190CF-P
Document #:
Insert Dimensions:
Final Fold Dimensions:
Packaging Line:
Vendor Drawing Date:
AP Pharma Code: 159

Package Insert - 81 mg Vial
United Kingdom
Product # 2001151
Package Insert to scale.
Q_0550665
190 mm x 340 mm
95 mm x 20 mm = +/– 2 mm
Cam
August 7, 2015
2D Material Code: 2039159

Part Number: 2039159
File Name: 177 PI 2039159 V3 UK 1x1 26Oct16
Date: 26 Oct 2016
Initials: MB
Fonts:

Product ID: 177
Version: 3

Gills Sans MT Pro

Colour: Black

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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
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.
BCG may persist in the urinary tract for several months after treatment with
ImmuCyst 81 mg. Disseminated BCG infection may develop months or years
after BCG therapy is given. Patients who receive medications which suppress
the immune system after BCG therapy may be at higher risk of BCG infection.
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
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PATIENT INFORMATION LEAFLET
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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.

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.

340mm

ImmuCyst®
BCG Immunotherapy
Dieline D54-190CF-P
Document #:
Insert Dimensions:
Final Fold Dimensions:
Packaging Line:
Vendor Drawing Date:
AP Pharma Code: 159

Package Insert - 81 mg Vial
United Kingdom
Product # 2001151
Package Insert to scale.
Q_0550665
190 mm x 340 mm
95 mm x 20 mm = +/– 2 mm
Cam
August 7, 2015
2D Material Code: 2039159

Part Number: 2039159
File Name: 177 PI 2039159 V3 UK 1x1 26Oct16
Date: 26 Oct 2016
Initials: MB
Fonts:

Product ID: 177
Version: 3

Gills Sans MT Pro

Colour: Black

190mm

20mm

95mm

20mm

FOLD

20mm

FOLD

20mm

FOLD

20mm

FOLD

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.
• 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

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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)
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.
• 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.

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• 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
Reporting of side effects
If you get any side effects, talk to your doctor, nurse or pharmacist. This
includes any possible side effects not listed in this leaflet. You can also report
side effects directly via the internet at www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more information on the safety
of this medicine.
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
2° and 8°C. 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 approximately 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 Limited
Avonbridge House
Bath Road
Chippenham
Wiltshire SN15 2BB
Manufacturer
Sanofi Pasteur Limited, Toronto, Ontario, Canada
This leaflet was last revised in: October 2016

R4-1016 UK
D54-190CF-P
2039159-177

ImmuCyst® is a registered trademark of Sanofi Pasteur Limited.
Alliance, Alliance Pharmaceuticals and associated devices are registered
trademarks of Alliance Pharmaceuticals Limited.
© Alliance Pharmaceuticals Limited 2016

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.
R4-1016 UK
D54-190CF-P
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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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