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MITOMYCIN 40 MG POWDER AND SOLVENT FOR INTRAVESICAL SOLUTION

Active substance(s): MITOMYCIN

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Package leaflet: Information for the user

Mitomycin, 40 mg,
powder and solvent for intravesical solution
Mitomycin
Read all of this leaflet carefully before you start using
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 pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them, even
if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet
1. What Mitomycin is and what it is used for
2. What you need to know before you use Mitomycin
3. How to use Mitomycin
4. Possible side effects
5. How to store Mitomycin
6. Contents of the pack and other information
1. What Mitomycin is and what it is used for
Mitomycin is a medicine for the treatment of cancer, i.e. a
medicine which prevents or considerably delays the division
of active cells by influencing their metabolism in various
ways. The therapeutic use of cytostatics in cancer therapy is
based on the fact that one way in which cancer cells differ

from normal cells in the body is that the rate of cell division is
increased due to a lack of control of their growth.
Therapeutic indications
Application in the urinary bladder (intravesical application) for
the prevention of a relapse in the case of superficial urinary
bladder cancer after removal of tissue through the urethra
(transurethral resection).

(especially in older people and during long-term treatment
with mitomycin); infection may be aggravated due to bone
marrow depression and may lead to fatal conditions,
• if you are of child-bearing age as mitomycin may affect
your ability to have children in the future.
Mitomycin is a substance that can cause significant
hereditary changes in genetic material, and can also cause
cancer in humans.

2. What you need to know before you use Mitomycin

Avoid contact with the skin and mucous membranes.

Mitomycin may only be administered if strictly indicated,
and by doctors experienced in this type of therapy.

Children and adolescents
The use of mitomycin in children and adolescents is not
recommended.

Do not use Mitomycin
• if you are allergic to mitomycin or any of the other
ingredients of this medicine (listed in section 6),
• while breast-feeding: you must not breast-feed during
treatment with mitomycin,
• if you have a perforation of the bladder wall,
• if you suffer from an inflammation of the urinary bladder
(cystitis).
Warnings and precautions
Talk to your doctor or pharmacist before using Mitomycin.
Particular caution is required when using Mitomycin
• if you are in poor general health,
• if you are suffering from impaired lung, kidney or
liver function,
• if you are undergoing radiation therapy,
• if you are being treated with other cytostatics
(substances which inhibit cell growth/cell division),
• if you have been told that you have bone marrow
depression (your bone marrow is not able to make
the blood cells that you need) it may become worse

There are reports from animal experiments that the effect of
mitomycin gets lost, if administered together with vitamin B6.
You should not get vaccinated with live vaccines during
mitomycin treatment because this may put you at an
increased risk to get infected by the live vaccine.
The harmful effect on the heart of Adriamycin (doxorubicin,
a medicine belonging to the group of cytostatics) can be
intensified by mitomycin.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.

Mitomycin can cause inherited genetic damage. As a man
treated with mitomycin you are therefore advised not to
father a child during treatment and for 6 months afterwards
and to seek advice on sperm conservation before starting
treatment due to the possibility of irreversible infertility
caused by mitomycin therapy.

4. Possible side effects

Driving and using machines
Even when used in accordance with instructions this
medicine may cause nausea and vomiting and thereby
reduce your reaction times to such an extent that the ability
to drive a motor vehicle or operate machinery is impaired.
This applies in particular in conjunction with alcohol.

Common side effects (may affect up to 1 in 10 people):
• bladder inflammation (cystitis) which may be
accompanied by blood in the bladder/urine
• painful urination (dysuria)
• frequent urination at night (nocturia)
• excessive frequent urination (pollakiuria)
• blood in the urine (haematuria)
• local irritation of the bladder wall
• localised skin rash (local exanthema)
• allergic skin rash
• skin rash caused by contact with mitomycin
(contact dermatitis)
• numbness, swelling and painful redness of palms
and soles (palmar-plantar erythema)

3. How to use Mitomycin
Other medicines and Mitomycin
There are no known interactions of intravesically given
mitomycin with other medicines.

If other forms of treatment (in particular other anti-cancer
medicines, radiation) which also have a harmful effect on the
bone marrow are used at the same time, it is possible that
the harmful effect of mitomycin on the bone marrow will be
intensified.

Pregnancy
Mitomycin can cause inherited genetic damage and can
adversely affect the development of an embryo.
You must not become pregnant during treatment with
mitomycin: If you become pregnant, genetic counselling
must be provided.
You should not use mitomycin during pregnancy. If you are
pregnant your doctor will decide whether there is a vital
indication for treating you with mitomycin and will advise you
of the risk of harmful effects on your unborn child associated
with the treatment.

Combination with vinca alkaloids or bleomycin (medicines
belonging to the group of cytostatics) can intensify the
harmful effect on the lungs.

Breast-feeding
Mitomycin passes into breast milk. Breast-feeding must be
discontinued during treatment.

An increased risk of a particular form of kidney disease
(haemolytic-uraemic syndrome) has been reported in patients
receiving a concomitant administration of mitomycin and
5-fluorouracil or tamoxifen.

Fertility / Contraception in males and females
As a sexually mature patient you must take contraceptive
measures or practise sexual abstinence during
chemotherapy and for 6 months afterwards.

Possible interaction under systemic therapy

Mitomycin should only be administered by healthcare
professionals experienced in this kind of therapy.
Mitomycin is intended to be used for introduction into the
urinary bladder (intravesical instillation) after being dissolved.
Your doctor will prescribe a dose that is right for you.

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Possible side effects following instillation in the bladder

Rare (may affect up to 1 in 1,000 people):
• rash over the whole body (generalised exanthema)

If you use more Mitomycin than you should
If you have been accidentally given a higher dose you may
experience symptoms such as fever, nausea, vomiting
and blood disorders. Your doctor may give you supportive
treatment for any symptoms that may occur.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

Very rare (may affect up to 1 in 10,000 people):
• bladder inflammation with damage of the bladder tissue
(necrotising cystitis)
• allergic (eosinophilic) bladder inflammation (cystitis)
• narrowing (stenoses) of the urinary tract
• reduced bladder capacity
• calcium deposits in the bladder wall (bladder wall
calcification)
• partial conversion of bladder wall tissue into connective
tissue (bladder wall fibrosis)
• decreased number of white blood cells (leukopenia)
increasing the risk of infections

• decreased number of platelets (thrombopenia) causing
bruises and bleeding
• systemic allergic reactions
• lung disorder presenting as shortness of breath, dry
cough and crackling sounds when breathing in (interstitial
lung disease)
• increased levels of liver enzymes (transaminases
increased)
• hair loss (alopecia)
• feeling sick (nausea) and being sick (vomiting)
• diarrhoea
• kidney disease (renal dysfunction) where you pass little or
no urine
• fever
Possible side effects following administration into a vein
Severe allergic reaction (symptoms may include faintness,
skin rash or hives, itching, swelling of lips, face and airway
with difficulty in breathing, loss of consciousness (may affect
up to 1 in 10,000 people) may occur.
Severe lung disease presenting as shortness of breath, dry
cough and crackling sounds when breathing in (interstitial
pneumonia) as well as severe renal dysfunction, kidney
disease where you pass little or no urine, etc. may occur.
If you notice any of the above reactions please inform your
doctor immediately because mitomycin therapy must be
stopped.
Very common side effects
(may affect more than 1 in 10 people):
• inhibition of blood cell production in the bone marrow
(bone marrow suppression)
• decreased number of white blood cells (leukopenia)
increasing the risk of infections

• decreased number of platelets (thrombopenia) causing
bruises and bleeding
• feeling sick (nausea) and being sick (vomiting)
Common side effects (may affect up to 1 in 10 people):
• lung disorder presenting as shortness of breath, dry
cough and crackling sounds when breathing in (interstitial
pneumonia)
• difficulties breathing (dyspnoea), cough,
shortness of breath
• skin rash (exanthema)
• allergic skin rash
• skin rash caused by contact with mitomycin
(contact dermatitis)
• numbness, swelling and painful redness of palms
and soles (palmar-plantar erythema)
• kidney disorders (renal dysfunction, nephrotoxicity,
glomerulopathy, increased levels of creatinine in the
blood) where you pass little or no urine
In the event of injection or leakage of mitomycin into the
surrounding tissue (extravasation)
• inflammation of connective tissue (cellulitis)
• death of tissue (tissue necrosis)
Uncommon side effects
(may affect up to 1 in 100 people):
• inflammation of the mucous membranes (mucositis)
• inflammation of the mucous membranes in the mouth
(stomatitis)
• diarrhoea
• hair loss (alopecia)
• fever
• loss of appetite (anorexia)

Rare (may affect up to 1 in 1,000 people):
• life-threatening infection
• blood poisoning (sepsis)
• decrease in number of red blood cells due to an abnormal
breakdown of these cells (haemolytic anaemia)
• heart failure (cardiac insufficiency) after previous therapy
with anti-cancer medicines (anthracycline)
• raised blood pressure in the lungs, e.g. leading to shortness
of breath, dizziness and fainting (pulmonary hypertension)
• disease involving obstruction of the veins in the lungs
(pulmonary veno-occlusive disease, PVOD)
• liver disease (liver dysfunction)
• increased levels of liver enzymes (transaminases)
• yellowing of the skin and whites of the eyes (icterus)
• disease involving obstruction of the veins in the liver
(veno-occlusive liver disease, VOD)
• rash over the whole body (generalised exanthema)
• a particular form of kidney failure (haemolytic uraemic
syndrome, HUS) characterised by haemolytic anaemia,
acute kidney failure, and a low platelet count
• a type of haemolytic anaemia caused by factors in
the small blood vessels (microangiopathic haemolytic
anaemia, MAHA)
Very rare (may affect up to 1 in 10,000 people):
• severe allergic reaction (symptoms may include faintness,
skin rash or hives, itching, swelling of lips, face and airway
with difficulty in breathing, loss of consciousness)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme 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 Mitomycin
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated
on the label and carton after “EXP”. The expiry date refers to
the last day of that month.

• The other ingredients are:
Powder for solution for intravesical use:
Urea
Solvent for intravesical solution:
Sodium chloride and water for injections

Germany:
mito-extra

What Mitomycin looks like and contents of the pack

Romania:
Mitomicină medac

Do not store above 25 °C.
Keep the vial in the outer carton in order to protect from light.

Mitomycin is a grey to grey-blue powder.
The solvent is a clear and colourless solution.

From a chemical and physical point of view the reconstituted
product should be used within 24 hours.

Mitomycin powder and solvent for intravesical solution
(instillation set) is available in packs with 1, 4 or 5 clear glass
vials (50 ml) with a coated rubber stopper and aluminium
seal. Instillation sets for intravesical instillation also include
1, 4 or 5 PVC bags with a volume of 40 ml containing
0.9 % sodium chloride solution and catheters.

From a microbiological point of view, unless the method of
opening/reconstitution/dilution precludes the risk of microbial
contamination, the product should be used immediately.
If not used immediately, in-use storage times and conditions
are the responsibility of the user.
Protect the reconstituted solution from light.
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.

Marketing Authorisation Holder and Manufacturer
medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany
Tel.: +49 4103 8006-0
Fax: +49 4103 8006-100
This medicinal product is authorised in the Member
States of the EEA under the following names:

• The active substance is mitomycin.
1 vial powder for solution for intravesical use contains
40 mg mitomycin. After reconstitution with 40 ml solvent
1 ml solution for intravesical use contains 1 mg mitomycin.

Austria, Belgium, Czech Republic, Denmark, Estonia,
Finland, Hungary, Iceland, Ireland, Latvia, Lithuania,
Netherlands, Norway, Poland, Slovak Republic, Sweden:
Mitomycin

Reconstitution of the solution for intravesical use ready
for use
Dissolve the content of one vial of Mitomycin (equivalent
to 40 mg mitomycin) in 40 ml sterile 0.9 % sodium chloride
solution. The contents of the vial must dissolve to form a
blue-purple clear solution within 2 minutes.

Slovenia
Mitomicin medac

Only clear solutions may be used.

United Kingdom
Mitomycin

The content of the vials is intended for single use/single entry
only. Unused solution must be discarded.

Instructions for use for the solvent for intravesical solution
(instillation set)

(6)

(3)

Invert the entire system. Hold the vial
up and pump in air. Draw the dissolved
mitomycin into the instillation system.
Do not remove the vial.

Holding the vial vertically, push it firmly
onto the adapter of the instillation
system and turn once or twice.

Fig. 1 – 7:
(1)
Tear open the protective cover, but
do not remove completely! This will
keep the tip of the instillation system
protected from contamination until the
last minute.

(7)
(4)

This leaflet was last revised in 10/2015.

Not all pack sizes may be marketed.

6. Contents of the pack and other information
What Mitomycin contains

Italy, Portugal:
Mitomicina medac

The urine pH should be higher than pH 6.

The following information is intended for healthcare
professionals only:

From a chemical and physical point of view the reconstituted
product should be used within 24 hours.
From a microbiological point of view, unless the method of
opening/reconstitution/dilution precludes the risk of microbial
contamination, the product should be used immediately.

Posology

If not used immediately, in-use storage times and conditions
are the responsibility of the user.

There are many intravesical mitomycin regimens, varying in
dose of mitomycin used, the frequency of instillation and the
duration of therapy.

Mitomycin must not be used in mixed injections. Other
solutions for injection or infusion must be administered
separately.

Unless otherwise specified, the dosage of mitomycin is
40 mg mitomycin instilled into the bladder once weekly.
Regimens with instillations every 2 weeks, every month or
3 monthly can also be used.

Any unused medicinal product or waste material should be
disposed of in accordance with local requirements.

The specialist should decide on the optimum regime,
frequency and duration of therapy on an individual patient
basis.

Holding the tube (not the vial) firmly in
the vertical position, break the upper
valve by bending it backwards and
forwards.

(2)
Remove the caps from the vial and the
instillation system. Place the disposal
bag ready to hand.
(5)

Hold the instillation system vertically.
Now remove the protective cover
completely. Connect the catheter to
the system. Now break the sealing
mechanism in the tube section by
bending backwards and forwards and
instil the solution. After completing
the instillation, release the catheter by
squeezing air through. Keep the solvent
bag squeezed together and transfer
with the catheter to the disposal bag.

Pump the liquid into the vial, but do not
fill the vial completely.

70233-VBGB
AA

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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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