Skip to Content

MITOMYCIN 1 MG/ML POWDER FOR SOLUTION FOR INJECTION/INFUSION OR INTRAVESICAL USE

Active substance(s): MITOMYCIN

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user

Mitomycin 1 mg/ml,
powder for solution for injection/infusion
or intravesical use
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
Mitomycin is used in cancer therapy for the relief of
symptoms (palliative cancer therapy).
Intravenous application
When administered intravenously the medicine is used in
monochemotherapy (i.e. treatment with only one active
substance) or in combined cytostatic chemotherapy (i.e.
treatment with several active substances). Mitomycin is
effective in the case of the following tumours:
• advanced bowel cancer (colorectal carcinoma)
• advanced stomach cancer (gastric carcinoma)
• advanced and/or metastatic breast cancer
(breast carcinoma)
• advanced cancer of the oesophagus
(oesophageal carcinoma)
• advanced cancer of the cervix (cervical carcinoma)
• non-small-cell lung cancer (bronchial carcinoma)
• advanced cancer of the pancreas (pancreatic carcinoma)
• advanced tumours of the head and neck.

Intravesical application
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).
2. What you need to know before you use Mitomycin
Mitomycin may only be administered if strictly indicated,
with continuous monitoring of the blood count, and by
doctors experienced in this type of therapy.
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.
• in the case of systemic administration:
• if you suffer from a major reduction in the number of
all types of blood cells (including red and white blood
cells as well as platelets [pancytopenia]), or an isolated
reduction of white blood cells (leukopenia) or blood
platelets (thrombocytopenia),
• if you suffer from a tendency to bleed (haemorrhagic
diathesis),
• in acute infections (disease caused by pathogens).
• in the case of intravesical administration (application in
the urinary bladder):
• 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
(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.

Other medicines and Mitomycin
Tell your doctor or pharmacist if you are taking/using, have
recently taken/used or might take/use any 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.
Combination with vinca alkaloids or bleomycin (medicines
belonging to the group of cytostatics) can intensify the
harmful effect on the lungs.
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.

Mitomycin is a substance that can cause significant
hereditary changes in genetic material, and can also cause
cancer in humans.

The harmful effect on the heart of Adriamycin (doxorubicin,
a medicine belonging to the group of cytostatics) can be
intensified by mitomycin.

Avoid contact with the skin and mucous membranes.

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.

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

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

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.

• 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)

3. How to use Mitomycin
Mitomycin should only be administered by healthcare
professionals experienced in this kind of therapy.
Mitomycin is intended to be used for injection or infusion
into a blood vessel (intravenous use) or for introduction
into the urinary bladder (intravesical instillation) after being
dissolved.

4. Possible side effects

Your doctor will prescribe a dose and treatment
regimen that is right for you.

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.

Before you receive mitomycin as injection or infusion a
blood test, check of lung, kidney and liver function is
recommended to exclude any diseases that could worsen
during mitomycin therapy.
The needle must remain in the blood vessel while
mitomycin is being given. If the needle comes out or
becomes loose, or the medicine is leaking into the tissue
outside the vein (you may feel discomfort or pain) tell the
doctor or nurse immediately.
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

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Possible side effects following administration into a vein

Severe lung disease presenting as shortness of breath,
dry cough and crackles 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)

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)
Possible side effects following instillation in the bladder
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)
Rare (may affect up to 1 in 1,000 people):
• rash over the whole body (generalised exanthema)
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

Store the vial in the outer carton in order to protect the
contents from light.

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.

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.

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.
From a chemical and physical point of view the
reconstituted product should be used within 24 hours.
From a microbiological point of view, this product
should be used immmediately. If not used immediately,
in-use storage times and conditions prior to use are the
responsibility of the user and would normally not be
longer than 24 hours at 2 to 8 °C, unless reconstitution /
dilution has taken place in controlled and validated aseptic
conditions.
Protect the reconstituted solution from light.

6. Contents of the pack and other information

5. How to store Mitomycin

What Mitomycin contains
• The active substance is mitomycin.
• The other ingredient is urea.

Keep this medicine out of the sight and reach of children.

One vial contains 2 mg, 10 mg, 20 mg or 40 mg mitomycin.

What Mitomycin looks like and contents of the pack
Mitomycin is a grey to grey-blue powder, for solution for
injection or infusion or solution for intravesical use in a vial
with a coated rubber stopper and aluminium seal.
Each vial contains 2, 10, 20 or 40 mg of mitomycin.
Each pack of Mitomycin contains 1, 5 or 10 vials.

Romania:
Mitomicină medac
Slovenia
Mitomicin medac
United Kingdom:
Mitomycin

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

If the powder does not dissolve immediately, leave to stand
at room temperature until fully dissolved. The contents of
the vial must dissolve to form a blue-purple clear solution
within 2 minutes.

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.

Reconstitution of the solution for intravesical use ready
for use
Mitomycin 2 mg:
Dissolve the contents of 10 - 20 vials of Mitomycin 2 mg
(equivalent to 20 - 40 mg mitomycin) in 20 - 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.

Not all pack sizes may be marketed.
This leaflet was last revised in 11/2015.

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

The following information is intended for healthcare
professionals only:

The urine pH should be higher than pH 6.

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:
Austria, Belgium, Czech Republic, Denmark, Estonia,
Finland, Germany, Hungary, Iceland, Latvia, Lithuania,
Norway, Poland, Slovak Republic, Spain:
Mitomycin
Italy, Portugal:
Mitomicina medac

Posology
Intravenous administration
In cytostatic monochemotherapy, mitomycin is usually
administered intravenously as a bolus injection.
The recommended dosages are 10 - 20 mg/m2 body
surface area every 6 - 8 weeks, 8 - 12 mg/m2 body surface
area every 3 - 4, weeks or 5 - 10 mg/m2 of body surface
every 3 - 6 weeks, depending on the therapeutic scheme
used.
In combination therapy, the dosage is considerably lower.
Because of the risk of additive myelotoxicity, proven
treatment protocols may not be deviated from without
a specific reason.

Reconstitution of the solution for injection or infusion ready
for use
Mitomycin 2 mg:
Dissolve the contents of one 2 mg vial of Mitomycin
in 2 ml water for injections by inverting the vial.
Mitomycin 10 mg:
Dissolve the contents of one 10 mg vial of Mitomycin in
10 ml water for injections by inverting the vial.
Mitomycin 20 mg:
Dissolve the contents of one 20 mg vial of Mitomycin in
20 ml water for injections by inverting the vial.

Mitomycin 10 mg:
Dissolve the contents of 2 - 4 vials of Mitomycin 10 mg
(equivalent to 20 - 40 mg mitomycin) in 20 - 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.
Mitomycin 20 mg:
Dissolve the contents of 1 - 2 vials of Mitomycin 20 mg
(equivalent to 20 - 40 mg mitomycin) in 20 - 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.
Mitomycin 40 mg:
Dissolve the contents of one vial of Mitomycin 40 mg
(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.
Notes
From a chemical and physical point of view the
reconstituted product should be used within 24 hours.
From a microbiological point of view, this product
should be unsed immmediately. If not used immediately,
in-use storage times and conditions prior to use are the
responsibility of the user and would normally not be
longer than 24 hours at 2 to 8 °C, unless reconstitution /
dilution has taken place in controlled and validated aseptic
conditions.
Only clear solutions must be used. The content of the
vials is for single use/single entry only. Unused solution
must be discarded. Mitomycin must not be used in mixed
injections. Other solutions for injection or infusion must be
administered separately.
Intravascular injection, avoiding extravasation, is essential.

70200-VBGB
AA

Expand view ⇕

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.

Hide