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MITOMYCIN 20 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION OR INTRAVESICAL USE

Active substance(s): MITOMYCIN

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Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Mitomycin

Market

UK

Language

English

Size

170 x 550 mm (PIL)

Min. Font Size

9

Version No.

3 (Page 1 of 2) (IA01)

Date

13.02.16 (Mitomycin (ACC-UK) IA01-PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

PACKAGE LEAFLET: INFORMATION FOR THE
USER

Mitomycin 2 mg powder
for solution for
injection/infusion or
intravesical use
Mitomycin 10 mg powder
for solution for
injection/infusion or
intravesical use
Mitomycin 20 mg 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 or nurse.
• This medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
• If you get any of the side effects, talk to your
doctor or pharmacist or nurse. 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 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)
Intravesical application
Application in the urinary bladder (intravesical
application) for the prevention of a relapse in the
case of superficial urinary bladder cancer after
the ablation of tissue through the urethra
(transurethral resection).

2. What you need to know before
you use Mitomycin

Approved By
Quality Assurance

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 division).
- if you have inflammation of the urinary bladder
(in case of intravesical administration).
- 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 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
future.
- if you have bleeding tendency and occurrence
of infectious disease.
- if you are immunized with live virus vaccine as
this increase risk of infection.
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 if you are taking or have recently
taken any other medicines or might take 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 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
doctor.
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 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.

Do not use Mitomycin if you:
• are allergic (hypersensitive) to mitomycin or any
of the other ingredients of Mitomycin
• during breastfeeding
• 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
(leucopenia) or blood platelets
(thrombocytopenia), a tendency to bleeding
(haemorrhagic diathesis) or acute infections
(disease caused by pathogens).
• in the case of intravesical administration
(application in the urinary bladder) if you have
perforation of the bladder wall

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 following information is intended for
healthcare professionals only

administration is 10-20 mg/m2 of body surface
every 6 – 8 week, 8-12 mg/m2 of body surface
every 3-4 weeks or 5-10 mg/m2 of body surface
every 1-6 weeks. A dose greater than 20 mg/m2
gives more toxic manifestations without
therapeutic benefits. The maximum cumulative
dose of mitomycin is 60 mg/m2.
The recommended dose by intravesical
administration is 20-40 mg of mitomycin instilled
weekly into bladder for 8 to 12 weeks. Alternative
dose recommendation in the prevention of
recurrent superficial bladder tumours is 4-10 mg
(0.06-0.15 mg/kg of body weight) instilled into the
bladder though a urethral catheter 1 or 3 times
per week. The solution should be retained in the
bladder for 1-2 hours.

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
infusion.
• 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.
Contact with the skin and mucous membranes is
to be avoided.
Posology and Method of administration
The recommended dose by intravenous

Note: PIL is required centrally folded in bible paper

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.

Mitomycin is intended for intravenous injection or
infusion or for intravesical instillation after being
dissolved.
Intravenous use:
Mitomycin 2, 10, 20 mg, powder for solution for
injection/infusion or intravesical use may not be
reconstituted in water.
The contents of the vial should be reconstituted
with saline or 20% glucose solution in a ration of :
2 ml for the 2 mg of mitomycin.
10 ml for the 10 mg of mitomycin.
20 ml for the 20 mg of mitomycin.

Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Mitomycin

Market

UK

Language

English

Size

170 x 550 mm (PIL)

Min. Font Size

9

Version No.

3 (Page 2 of 2) (IA01)

Date

13.02.16 (Mitomycin (ACC-UK) IA01-PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

Approved By
Quality Assurance

If you are given 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.

• Bladder inflammation (cystitis) - which may be
accompanied with blood in the bladder/urine
• Painful urination, excessive frequent urination
sometimes over the night (dysuria, pollakisuria,
nocturia)
• Blood in urine (hematuria)
• Local irritation of the bladder wall

If you have any further questions on the use of
this medicine, please ask your doctor or
pharmacist.

Rare (may affect up to 1 in 1,000 people)
• Widespread skin rash

4. 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 allergic reaction (symptoms may include
faintness, skin rash or hives, itching, swelling of
lips, face and airway with difficulty in breathing,
loss of consciousness – very rare (may affect up
to 1 in 10,000 people).
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 rare (may affect up to 1 in 10,000 people)
• Severe inflammation of the bladder where
portions of the bladder wall may undergo tissue
death (allergic cystitis, necrotizing cystitis)
• Stenosis of the efferent urinary tract
• Reduction in bladder capacity
• Hardening of bladder wall (bladder wall
calcification, bladder wall fibrosis)
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
Website: 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

Very common (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

Keep out of the sight and reach of children.

Common (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)

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 to protect the environment.

Uncommon (may affect up to 1 in 100 people)
• Inflammation of a mucous membrane (mucositis)
• Inflammation of the mucosa of 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
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

Mitomycin does not require any special storage
condition.
Do not use Mitomycin after the expiry date which
is stated on the label after “Exp Date”. The expiry
date refers to the last day of that month.

6. Contents of the pack and
other information
What Mitomycin contains
- The active substance is mitomycin
- The other ingredient is mannitol
The 10 and 20 mg vials are packaged into
cartons containing 1 or 5 vials. The 2 mg vials
are packaged into cartons containing 1, 5 or 10
vials.
What Mitomycin looks like and contents of
the pack
Mitomycin Powder for Solution for Injection is a
powder which is mixed before injection. It is
packaged in glass vials with a rubber stopper and
aluminium seal.
Marketing Authorisation Holder and
manufacturer:
Marketing Authorisation Holder
Accord Healthcare Limited
Sage House, 319 Pinner Road,North Harrow,
Middlesex, HA1 4HF, United Kingdom
Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow,
Middlesex, HA1 4HF, United Kingdom
The leaflet was last revised in 02/2016.

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 installation in
the bladder
Common (may affect up to 1 in 10 people)
• Skin rashes (exanthema, allergic skin rash,
contact dermatitis)
• Numbness, swelling and painful redness on
palms and soles (palmar-plantar erythema)

Reconstitution/ Concentration pH range Osmolality
Dilution Fluid
Saline
1.0 mg/mL,
4.5 – 7.5 Approx.
(Reconstitution)
290
0.1 mg/mL
mOsm/Kg
(Dilution)
20% glucose
1.0mg/mL,
3.5 – 7.0 Approx.
solution
(Reconstitution)
1100
0.1 mg/mL
mOsm/Kg
(Dilution)

Intravesical use:
Mitomycin 2, 10, 20 mg, powder for solution for
injection/infusion or intravesical use may not be
reconstituted in water.
The contents of the vial should be reconstituted
with saline or phosphate buffer 7.4 in a ration of :
2 ml for the 2 mg of mitomycin.
10 ml for the 10 mg of mitomycin.
20 ml for the 20 mg of mitomycin.
Reconstitution Concentration pH range Osmolality
Fluid
Saline
1.0mg/mL
4.5 – 7.5 Approx. 290
mOsm/Kg
Phosphate
1.0mg/mL
6.0 – 8.5 Approx. 185
Buffer pH 7.4
mOsm/Kg

Note: PIL is required centrally folded in bible paper

Pregnant healthcare personnel should not handle
and/or administer drug product. Mitomycin should
not be allowed to come into contact with the skin.
If it does, it should be washed several times with
8.4% sodium bicarbonate solution, followed by
soap and water. Hand creams and emollients
should not be used as they may assist the
penetration of the drug into the epidermal tissue.
In the event of contact with the eye, it should be
rinsed several times with saline solution. It should
then be observed for several days for evidence of
corneal damage. If necessary, appropriate
treatment should be instituted.
The reconstituted product should be used
immediately.
Note:
- Mitomycin 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.

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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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