Mitomycin parenteral and intravesical
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Parenteral and intravesical formulations of mitomycin.
Carcinoma - cervix
Carcinoma - prostate
Carcinoma of pancreas
Locally advanced/metastatic Non-Small Cell Lung Cancer (NSCLC)
Metastatic breast cancer
Skin cancer: treatment
Squamous cell carcinoma of head and neck
Superficial bladder carcinoma
Treatment of colorectal carcinoma
Treatment of gastric carcinoma
Advanced squamous cell carcinoma of the uterine cervix
Head and neck cancer
Lung cancer (particularly non-small cell)
Metastatic breast cancer
Metastatic gastric carcinoma
Oesophageal squamous cell carcinoma
Other non-solid tumours
Superficial bladder cancer, and relapse prevention after transurethral resection
Due to the complexity and specialist nature of dosage regimens for the treatment of malignant disease, specific dosage information on this agent is not included.
The method of administration for mitomycin is dependant on the indication being treated.
Possible methods of administration include intravenous, intra-arterial and intravesical routes. Not all routes are licensed for all indications.
Obstructive pulmonary disease
Precautions and Warnings
Children under 18 years
Leucocyte count below 3 x 10 to the power of 9 / L
Platelet count below 90 x 10 to the power of 9 / L
Cystitis - if for intravesical use
Live virus vaccine should not be given for 3 months after treatment
Advise ability to drive/operate machinery may be affected by side effects
Give pre-treatment counselling and consideration of sperm cryopreservation
Not all available brands are licensed for all age groups
Not all available brands are licensed for all indications
Not all available brands are licensed for all routes of administration
Not all routes are licensed for all indications
Treatment to be initiated and supervised by a specialist
Avoid contact with skin and mucous membranes
Consult local policy on the safe use of anti-cancer drugs
If extravasation occurs follow local policy & seek expert help immediately
Staff: Not to be handled by pregnant staff
Blood counts should be performed before and periodically during treatment
Monitor renal function before treatment and regularly during treatment
Perform liver function tests before commencing therapy
Bone marrow suppression is cumulative
Risk of myelodysplastic syndrome and secondary malignancies
Suspend treatment and investigate signs of pulmonary toxicity
Consider treatment interruption & dose reduction in haematological toxicity
Discontinue if anaphylactoid reaction occurs
Discontinue therapy if nephrotoxicity occurs
Male: May cause infertility
Male & female: Contraception required during & for 6 months after treatment
Mitomycin therapy should be discontinued if disease progression continues after 2 courses of treatment.
Pregnancy and Lactation
Mitomycin is contraindicated during pregnancy.
The manufacturers state that mitomycin should not be used during pregnancy.
Mitomycin has been shown to be teratogenic, mutagenic and carcinogenic in animal studies.
Mitomycin is contraindicated during breastfeeding.
The manufacturers state that women must first discontinue breastfeeding prior to initiating treatment with mitomycin.
It is suggested that mitomycin is excreted in human breast milk. Based on its molecular weight and high lipid solubility, presence in human breast milk is possible. Due to the potential for serious adverse reactions in nursing infants, breastfeeding should be discontinued prior to and during treatment with mitomycin.
The effect of concurrent therapies must also be considered.
Allergic skin reactions
Bladder capacity reduced
Bladder outflow obstruction
Bladder wall calcification
Bone marrow depression
Elevation of liver enzymes
Haemolytic uraemic syndrome
Hepatic veno-occlusive disease
Hypersensitivity reactions including anaphylaxis
Impaired renal function
Increased bleeding tendency
Increased urinary frequency
Injection site reactions
Interstitial lung disease
Liver function disturbances
Microangiopathic haemolytic anaemia syndrome
Pulmonary veno-occlusive disease (PVOD)
Serum creatinine increased
Thrombotic thrombocytopenic purpura
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: June 2019
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 16 January 2018
Summary of Product Characteristics: Mitocin 20mg powder for solution for infusion. Vygoris Ltd. Revised August 2018.
Summary of Product Characteristics: Mitomycin 2mg, 10mg, 20mg powder for solution for infusion. Accord Healthcare Ltd. Revised February 2017.
Summary of Product Characteristics: Mitomycin C Kyowa 2mg, 10mg, 20mg powder for solution for infusion. Kyowa Kirin Ltd. Revised July 2018.
Summary of Product Characteristics: Mitomycin C Kyowa 40mg powder for intravesical solution. Kyowa Kirin Ltd. Revised May 2019.
Summary of Product Characteristics: Mitomycin 20mg and 40mg powder and solvent intravesical solution. medac GmbH. Revised April 2016.
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