Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Mitomycin medac 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 (cytostatic). 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 medac is introduced into the urinary bladder (intravesical application) to prevent recurrence of superficial urinary bladder cancer after the tissue affected by the cancer has been removed through the urethra (transurethral resection).
Mitomycin may only be administered if strictly indicated, and by doctors experienced in this type of therapy.
Do not use Mitomycin medac • 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 medac.
Particular caution is required when using Mitomycin medac
• 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 the elderly and during long-term treatment with mitomycin); infection may get worse due to low blood count 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.
If you experience abdominal pain or pain in the pelvic region that occurs straight after or weeks or months after the application of Mitomycin medac in the bladder inform your doctor immediately. It can be necessary that your doctor performs an abdominal sonography to clarify the cause of your pain.
Mitomycin is a substance that can cause significant hereditary changes in genetic material, and can potentially cause cancer in humans.
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.
Children and adolescents The use of Mitomycin medac in children and adolescents is not recommended.
Other medicines and Mitomycin medac 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)
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.
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.
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.
You should not use mitomycin 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.
Breast-feeding
Mitomycin probably passes into breast milk. Breast-feeding must be discontinued during treatment with Mitomycin medac.
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 use machines is impaired. This applies in particular if you consume alcohol at the same time.
Mitomycin medac is administered by trained healthcare personnel only.
This medicine 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.
Mitomycin medac is introduced into an empty bladder at low pressure by means of a catheter. Your healthcare professional will empty your bladder before the treatment with a catheter. Do not go to the toilet directly prior to your healthcare professional visit. 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 use more Mitomycin medac 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects following instillation 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.
Common: 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
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 (necrocis) of the surrounding area
• vesical fistula
Possible side effects following injection or infusion into a blood vessel (intravenous administration) 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 (leukopenia) increasing the risk of infections
• decreased number of platelets (thrombopenia) causing bruises and bleeding
• feeling sick (nausea) and being sick (vomiting)
Common: 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: 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
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)
• bruises (purpura) and red and purple dots (petechiae) on the skin (thrombotic thrombocytopenic purpura)
• heart failure (cardiac insufficiency) after previous therapy with anti-cancer medicines (anthracyclines)
• 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 destruction of red blood cells that outpaces your bone marrow’s production (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)
Not known: frequency cannot be estimated from the available data
• infection
• reduced blood cell count (anaemia)
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: 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.
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.
This medicine does not require any special temperature storage conditions.
Keep the vial in the outer carton in order to protect from light.
The physical and chemical in-use stability has been demonstrated for 48 hours when stored protected from light at room temperature (15 °C – 25 °C) and for 72 hours when stored protected from light at 2 °C – 8 °C in a refrigerator.
From a microbiological point of view, the medicinal product should be used immediately.
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 °C to 8 °C, protected from light, unless reconstitution has taken place in controlled and validated aseptic conditions. 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.
What Mitomycin medac contains • 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.
• The other ingredients are:
Powder for solution for intravesical use: Urea
Solvent for intravesical solution: Sodium chloride, water for injections, pH adjusting agents (1 M sodium hydroxide, 1 M hydrochloric acid).
What Mitomycin medac looks like and contents of the pack Mitomycin medac is a grey to grey-blue powder.
The solvent is a clear and colourless solution.
Mitomycin medac 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 APP* bags with a volume of 40 mL containing sodium chloride 9 mg/mL (0.9 %) solution for injection. The sets are available with or without catheters and/or connectors (Luer-Lock to conical).
* APP = Advanced Polypropylene (polyolefin/polypropylene/styrene-block copolymer)
Not all pack sizes may be marketed.
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, Denmark, Estonia, Finland, Iceland, Ireland, Latvia, Lithuania, Netherlands, Norway, Poland, Slovak Republic, Sweden:
Mitomycin medac
Germany:
mito-extra
Italy:
Miturox
Portugal:
Mitomicina medac
Slovenia
Mitomicin medac
United Kingdom
Mitomycin medac
This leaflet was last revised in 01/2025.
medac Pharma LLP
Address
Scion House, Stirling University Innovation Park, Stirling, FK9 4NF, UK
Telephone
+44 (0)1786 458 086
Medical Information e-mail
[email protected]
WWW
www.medacpharma.co.uk
• Contact us
• Links
• Accessibility
• Legal and privacy notice
• Cookie notice
• Cookie Settings
• Glossary
• Site Maps
Delivered to you by
Mitomycin medac, 40 mg, Powder and solvent for intravesical solution comes as powder containing 40 mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Mitomycin medac, 40 mg, Powder and solvent for intravesical solution is mitomycin.
Medicines with the same active substance include: Mitocin 20 mg, powder for solution for injection/infusion or intravesical use. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Mitomycin medac, 40 mg, Powder and solvent for intravesical solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Mitomycin medac is indicated as intravesical administration for relapse prevention in adults with superficial urinary bladder carcinoma after transurethral resection.
Mitomycin medac must be administered by physicians experienced in this therapy, only if strictly indicated.
Mitomycin medac is only intended for intravesical use following reconstitution.
Posology
The content of one vial is required for one bladder instillation.
There are many intravesical mitomycin regimens, varying in the dose of mitomycin used, the frequency of instillation and the duration of therapy.
Unless otherwise specified, the dose of mitomycin is 40 mg instilled into the bladder once weekly. Regimens with instillations every 2 weeks, every month or 3 monthly can also be used.
The specialist should decide on the optimum regimen, frequency and duration of therapy on an individual patient basis.
Special populations
Elderly
Insufficient data from clinical studies are available concerning the use of mitomycin in patients ≥ 65 years of age.
Renal or hepatic impairment
The medicinal product should be used with caution in patients with renal or hepatic impairment.
Paediatric population
The safety and efficacy of Mitomycin medac in children have not been established. No data are available.
Method of administration
Mitomycin medac is only intended for intravesical instillation after being dissolved.
It is advised to use this medicinal product at its optimal pH (urinary pH > 6) and to maintain the concentration of mitomycin by reducing fluid intake before, during and after instillation. The bladder must be emptied before instillation with a catheter. Mitomycin is introduced into the bladder by means of a catheter and at low pressure. The length of individual instillation should be 1 – 2 hours. During this period the solution should have sufficient contact with the entire mucosal surface of the bladder. Therefore, the patient should be mobilised as much as possible. After 2 hours the patient should void the instilled solution, preferably in a sitting position.
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
• Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1
• Breastfeeding
• Bladder wall perforation
• Cystitis
Possible interaction under systemic therapy
Myelotoxic interactions with other bone marrow-toxic treatment modalities (especially other cytotoxic medicinal products, radiation) are possible.
Combination with vinca alkaloids or bleomycin may reinforce pulmonary toxicity.
An increased risk of haemolytic-uraemic syndrome has been reported in patients receiving concomitant administration of intravenous mitomycin and 5-fluorouracil or tamoxifen.
In animal experiments, pyridoxine hydrochloride (vitamin B6) resulted in the loss of effect of mitomycin.
No injections with live vaccines should be carried out in connection with mitomycin treatment, as this may result in an increased risk of infection by the live vaccine.
The cardiotoxicity of doxorubicin may be reinforced by mitomycin.
Pregnancy
There are no data from the use of mitomycin in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Mitomycin has a mutagenic, teratogenic and carcinogenic effect and therefore may impair the development of an embryo.
Women must not become pregnant during treatment with mitomycin. In the event of pregnancy during treatment, genetic counselling must be provided.
Breast-feeding
It is suggested that mitomycin is excreted in human milk. Due to its proven mutagenic, teratogenic and carcinogenic effects, breastfeeding must be discontinued during treatment with Mitomycin medac (see section 4.3).
Fertility
Women of childbearing potential have to use effective contraception or practise sexual abstinence during chemotherapy and for 6 months afterwards.
Mitomycin is genotoxic. Men who are being treated with mitomycin are therefore advised not to father a child during treatment and up to 6 months thereafter and to seek advice on the preservation of sperm before the start of therapy due to the possibility of irreversible infertility caused by the therapy with mitomycin.
Even when used in accordance with instructions this medicinal product may cause nausea and vomiting and thereby reduce reaction times to such an extent that the ability to drive and use machines is impaired. This applies even more if alcohol is consumed at the same time.
In case of overdose severe myelotoxicity or even myelophthisis must be expected, with the full-blown clinical effect only appearing after approximately 2 weeks.
The period until which the number of leukocytes falls to the lowest value may be 4 weeks. Prolonged close haematological monitoring therefore also has to be carried out if an overdose is suspected.
However, up until now, no cases of overdose of intravesical administration of mitomycin have been reported.
As no effective antidote is available, the utmost caution should be exercised at each administration.
Ask anything about Mitomycin medac, 40 mg, Powder and solvent for intravesical solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
We use essential cookies to make the site work. We would also like to set optional cookies to understand how the site is used, so we can improve it. We will not set optional cookies unless you accept. See our cookie policy and privacy policy.