Mitomycin 2 mg powder for solution for injection/infusion or intravesical use – patient leaflet, side effects, dosage

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 in adults:

• 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) in adults.

2. What you need to know before you use Mitomycin

Do not use Mitomycin if you:

• are allergic to mitomycin or any of the other ingredients of this medicine (listed in section 6).
• during breastfeeding: you must not breast-feed during treatment with mitomycin.
• in the case of intravenous administration (injection or infusion into a blood vessel) 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 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 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 immunised with a live virus vaccine as this increases the risk of infection.

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

Intravesical administration

If you experience abdominal pain or pain in the pelvic region that occurs straight after or weeks or months after the application of Mitomycin in the bladder, inform your doctor immediately. It can be necessary that your doctor performs an ultrasound of the abdominal to clarify the cause of your pain.

Avoid contact with the skin and mucous membranes.

Please read the general hygiene instructions after an intravesical instillation into the bladder:

It is recommended to sit down for urinating to avoid spillage of the urine and to wash hands and genital area after urinating. This applies especially to the first urination following mitomycin administration.

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

No interactions with other medicines are known if mitomycin is given in the bladder (intravesical administration)

Possible interaction during injection or infusion in a blood vessel (intravenous administration)

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.

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

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

There are reports from animal experiments that the effect of mitomycin gets lost, if administered together with Vitamin B_6.

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.

Please note that the above also applies to medications used in the recent past.

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.

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. 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.

Fertility/Contraception in males and females

If you are of child-bearing age as mitomycin may affect your ability to have children in the future. 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.

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.

Breast-feeding

Mitomycin probably passes into breast milk. 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.

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.

Intravesical administration

Mitomycin is introduced into the bladder at low pressure by means of a catheter. You must empty your bladder before the treatment. The medicine should remain in the bladder for a period of 1 - 2 hours. To allow this, you should not drink too much liquid before, during and after the treatment. While the solution remains in your bladder, it should have sufficient contact with the entire mucosal surface, moving around supports the treatment. After 2 hours you should empty your bladder in a sitting position to avoid spillage.

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.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following information is intended for 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 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 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.

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 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.

Intravesical use:

The contents of the vial should be reconstituted with saline or phosphate buffer 7.4 or Water for Injection 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.

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.

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 where you pass little or no urine) may occur.

If you notice any of the above reactions please inform your doctor immediately because mitomycin therapy must be stopped.

Very common (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 (leucopenia) increasing the risk of infections;
• decreased number of platelets (thrombocytopenia) causing bruises and bleedings
• feeling sick (nausea) and being sick (vomiting)

Common (may affect up to 1 in 10 people)

• lung disorders presenting as shortness of breath, dry cough and inspiratory crackles (interstitial pneumonia)
• difficulties breathing (dyspnoea), cough, shortness of breath
• skin rashes (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) - 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 (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)
• bruises (purpura) and red and purple dots (petechiae) on the skin (thrombotic thrombocytopenic purpura)
• a type of haemolytic anaemia caused by factors in the small blood vessels (microangiopathic-haemolytic anaemia, MAHA syndrome),
• a particular form of kidney failure (haemolytic uraemic syndrome, HUS) characterised by destruction of red blood cells that outpaces your bone marrow’s production (haemolytic anaemia), acute kidney failure, and a low platelet count
• 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 (generalised exanthema)

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

  Not known (frequency cannot be estimated from the available data)

  • infections
  • reduced blood cell count (anaemia)

Possible side effects following installation in the bladder (intravesical use)

Please inform your doctor immediately if you notice any of the following reactions (which have been observed very rarely following instillation in the bladder), because mitomycin therapy will have to be stopped:

• severe allergic reaction, with symptoms such as faintness, skin rash or hives, itching, swelling of lips, face and airway with difficulty in breathing, loss of consciousness.
• severe lung disease presenting as shortness of breath, dry cough and crackling sounds when breathing in (interstitial pneumonia)
• severe renal dysfunction: kidney disease where you pass little or no urine.
• pelvic or abdominal pain.

Common (may affect up to 1 in 10 people)

• localised skin rashes (local exanthema)
• allergic skin rash
• skin rash caused by contact with mitomycin (contact dermatitis)
• numbness, swelling and painful redness on palms and soles (palmar-plantar erythrodysaesthesia (PPE)/hand-foot syndrome)
• 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

Rare (may affect up to 1 in 1,000 people)

• widespread skin rash (generalised exanthema)

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)
• narrowing (stenoses) of the efferent urinary tract
• reduction in bladder capacity
• calcium deposits in the of 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 (thrombocytopenia) 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

Not known (frequency cannot be estimated from the available data) If mitomycin reaches other regions than the bladder by accident:

• bladder damage
• pocket of pus in the abdomen (abscess)
• death of (fat) tissue (necrosis) of the surrounding area
• vesical fistula

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. 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.

Mitomycin does not require any special storage condition.

Use immediately after reconstitution.

Do not use Mitomycin after the expiry date which is stated on the label after “Exp”. The expiry date refers to the last day of that month.

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.

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

Accord Healthcare Polska Sp.z o.o., ul. Lutomierska 50,95-200 Pabianice, Poland

Accord Healthcare single member S.A.

64th Km National Road Athens, Lamia,

Schimatari, 32009, Greece

The leaflet was last revised in 02/2026.

The reconstituted solution is clear blue-violet colour free from visible particulate matter.

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

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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