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Active substance(s): MITOMYCIN

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Package leaflet: Information for the user
Mitomycin 40mg powder for solution for injection/infusion
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.
What is in this leaflet:1.

What Mitomycin is and what it is used for
What you need to know before you use Mitomycin
How to use Mitomycin
Possible side effects
How to store Mitomycin
Contents of the pack and other information.


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 application of medicinal products for the treatment of cancer 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 it 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 metastatic stomach cancer (stomach carcinoma)
 advanced and/or metastatic breast cancer (breast carcinoma)
 cancer of the respiratory tract (non-small cell bronchial carcinoma)
 advanced cancer of the pancreas (pancreatic carcinoma)
2. What you need to know before you use Mitomycin
Mitomycin must not be administered:


if you are hypersensitive (allergic) to mitomycin or any of the other constituents of
Mitomycin .
- during breastfeeding
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 (leucopenia) or blood platelets (thrombocytopenia), a tendency to bleeding (haemorrhagic
diathesis) or acute infections (disease caused by pathogens).
Warnings and precautions
Talk to your doctor or pharmacist before using Mitomycin
- if you are suffering from impaired lung, kidney or liver function.
- if your general state of health is not good
- if you are undergoing radiation therapy
- if you are being treated with other cytostatics (substances which inhibit cell growth/cell
- 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 be worse (especially in the elderly 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 capable to have a baby as mitomycin may affect your ability to have children in the
You will be given the treatment under the supervision of a healthcare professional who is
experienced in this particular branch of medicine to minimise any unwanted side effects in the
injection site.
Children and adolescents
The use of mitomycin in children and adolescents is not recommended.
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.
Through the additional use of other types of therapy (in particular other anti-cancer medicines,
radiation) which also have harmful effects on you, it is possible that the adverse effects of
mitomycin will be reinforced.
There are reports from animal experiments that the effect of mitomycin is lost, if administered
together with Vitamin B6.
You should not get vaccinated, especially with live vaccines during mitomycin treatment.
Please note that the above also applies to medications used in the recent past.
Pregnancy, breast-feeding and fertility

Mitomycin should not be used during pregnancy. Your doctor has to evaluate the benefit against
the risk of harmful effects on your child, if mitomycin treatment during pregnancy is necessary.
Women of child-bearing age should avoid becoming pregnant. Contraceptive measures must be
taken by both male and female patients during and for at least six months after cessation of
therapy. Still, if you become pregnant during this period you must immediately inform your
Breast-feeding must be discontinued before you start to use mitomycin.
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.

3. How to use Mitomycin
Mitomycin should only be administered by healthcare professionals experienced in this kind of
Mitomycin is intended to be used for injection or infusion into a blood vessel (intravenous use)
after being dissolved.
Your doctor will prescribe a dose and treatment regimen that is right for you.
Before you receive mitomycin as injection or infusion into a vein a blood test, check of lung,
kidney and liver function is recommended to exclude any diseases, which could worsen during
mitomycin therapy.
The needle must remain in the vein while mitomycin is being given. If the needle comes out or
becomes loose, or the medicinal product is going 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 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, please ask your doctor or

Possible side effects

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 during breath-in
(interstitial pneumonia) as well as severe renal dysfunction (nephrotoxicity) 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)

Blood disorders: Inhibition of blood cell production in the bone marrow; decreased
number of white blood cells (leucopenia) increasing the risk of infections; decreased
number of platelets (thrombocytopenia) causing bruises and bleedings

Nausea, vomiting
Common side effects (may affect up to 1 in 10 people)

Lung disorders presenting as shortness of breath, dry cough and inspiratory crackles
(interstitial pneumonia)

Dyspnoea, cough, shortness of breath

Skin rashes and irritation of the skin

Numbness, swelling and painful redness on palms and soles (palmar-plantar erythema)

Kidney disorders (renal dysfunction, nephrotoxicity, glomerulopathy, increased levels of
creatinine in the blood) - the kidneys may not be able to work

Inflammation of connective tissue (cellulitis) and death of tissue (tissue necrosis)
following accidental injection into the surrounding tissue (extravasation)
Uncommon side effects (may affect up to 1 in 100 people)

Inflammation of a mucous membrane (mucositis)

Inflammation of the mucosa of the mouth (stomatitis)


Hair loss (alopecia)


Loss of appetite (anorexia)
Rare side effects (may affect up to 1 in 1,000 people)

Life-threatening infection

Blood poisoning (sepsis)

Decrease in number of red blood cells sometimes together with a acute renal dysfunction
(haemolytic anaemia, microangiopathic-haemolytic anaemia (MAHA syndrome),
Haemolytic uraemic syndrome (HUS))

Loss of cardiac function (heart failure) after previous therapy with other anti-cancer
medicines (anthracyclines)

Increase in blood pressure in the vasculature of the lungs, e,g, leading to shortness of
breath, dizziness and fainting (pulmonary hypertension)

Obstructive disease of the pulmonary veins (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)

Blockage of the small veins in the liver (veno-occlusive disease [VOD] of the liver)
leading to fluid retention, increased liver size and raised levels of bilirubin in the blood

Widespread skin rash

Very rare side effects (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)
If you get any side effects talk to your doctor or pharmacist. This includes any side effects not
listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at agency’s website: By reporting side effects you can help provide more information
on the safety of this medicine.

How to store Mitomycin

Do not refrigerate or freeze.
Reconstituted solution: Chemical and physical in-use stability has been demonstrated in the
recommended diluents for 24 hours stored at 25°C and 2-8°C.
Diluted solution: After dilution, the solution should be used immediately
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 folding box after
“EXP”. The expiry date refers to the last day of that month.
Do not throw away any medicine via waste water or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help to protect the

Contents of the pack and other information

What Mitomycin contains
The active substance is mitomycin.
1 vial powder for solution for injection/infusion contains 40 mg mitomycin. After reconstitution
with 80 ml water for injections each ml solution contains 0.5 mg mitomycin.
The other ingredient is Mannitol (E421)
What Mitomycin looks like and contents of the pack

Mitomycin is a powder which is mixed before injection. It is packaged in an amber coloured
glass vials with a rubber stopper and aluminium seal.
Mitomycin is available in packs contains 1, 5 or 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Potters Bar
United Kingdom
Agila Specialties Polska Sp. z. o. o.
10, Daniszewska Str., 03-230 Warsaw
The leaflet was last revised on 10/2014
------------------------------------------------------------------------------------------------------The following information is intended for medical or healthcare professionals only:
General Information
It is essential that the injection is administered intravenous. If the medicinal product is injected
perivasally, extensive necrosis occurs in the area concerned. To avoid necrosis following
recommendations apply:
 Always inject into large veins in the arms.
 Do not directly inject intravenously, but rather into the tube of a good and securely running
 Before removing the cannula after central venous administration, flush it through for a few
minutes using the infusion in order to release any residual mitomycin.
If extravasation occurs, it is recommended that the area is immediately infiltrated with sodium
bicarbonate 8.4% solution, followed by an injection of 4 mg dexamethasone. A systemic
injection of 200 mg of Vitamin B6 may be of some value in promoting the regrowth of tissues
that have been damaged.
Contacts with the skin and mucous membranes must be avoided.
Method of administration
Mitomycin is intended for intravenous injection or infusion after being dissolved. Partial use is
Special precautions for disposal and other handling
Preparation of ready-to-use solution for injection or infusion

The contents of the vial should be reconstituted with water for injection or 0.9% sodium chloride
injection, to a concentration of 0.5mg/ml.
Preparation of Reconstituted solution
The contents of one vial of Mitomycin 40 mg are dissolved in 80 ml of water for injections or
0.9% sodium chloride solution. After reconstitution with 80 ml solvent each ml of solution
contains 0.5 mg mitomycin.
If the powder does not dissolve immediately, allow it to stand at room temperature until it has
completely dissolved. The contents of the vial must dissolve to form a clear solution within 2
For intravenous infusion the solution of Mitomycin 40 mg is further diluted with 0.9% sodium
chloride solution or Sodium Lactate Injection to a concentration of 20 or 40 micrograms of
 Mitomycin 40 mg must not be used in mixed injections.
 Other injection solutions or infusion solutions must be administered separately.
 It is essential that the injection is administered intravenous.
Any unused medicinal product or waste material should be disposed of in accordance with local
Diluted solution: After dilution, the solution should be used immediately

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