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Presentation

Parenteral and intravesical formulations of mitomycin.

Drugs List

  • MITOCIN 20mg powder for solution for injection vial
  • mitomycin 20mg powder and solvent for intravesical solution
  • mitomycin 20mg powder for solution for injection vial
  • mitomycin 40mg powder and solvent for intravesical solution
  • Therapeutic Indications

    Uses

    Carcinoma - cervix
    Carcinoma - prostate
    Carcinoma of pancreas
    Hepatocellular carcinoma
    Leukaemia
    Locally advanced/metastatic Non-Small Cell Lung Cancer (NSCLC)
    Malignant neoplasms
    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
    Colo-rectal cancer
    Head and neck cancer
    Hepatic cancer
    Leukaemias
    Lung cancer (particularly non-small cell)
    Metastatic breast cancer
    Metastatic gastric carcinoma
    Oesophageal squamous cell carcinoma
    Other non-solid tumours
    Pancreatic cancer
    Prostate cancer
    Sarcomas
    Skin cancers
    Superficial bladder cancer, and relapse prevention after transurethral resection

    Dosage

    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.

    Administration

    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.

    Contraindications

    Acute infection
    Haemorrhagic diathesis
    Bladder perforation
    Breastfeeding
    Coagulopathy
    Leucopenia
    Obstructive pulmonary disease
    Pancytopenia
    Pregnancy
    Thrombocytopenia

    Precautions and Warnings

    Children under 18 years
    Elderly
    Infection
    Leucocyte count below 3 x 10 to the power of 9 / L
    Platelet count below 90 x 10 to the power of 9 / L
    Varicella
    Cystitis - if for intravesical use
    Hepatic impairment
    Myelosuppression
    Renal impairment

    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

    Pregnancy

    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.

    Lactation

    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.

    Side Effects

    Acute leukaemia
    Albuminuria
    Allergic skin reactions
    Alopecia
    Anaemia
    Anaphylactoid reaction
    Anorexia
    Bladder atrophy
    Bladder capacity reduced
    Bladder fibrosis
    Bladder irritation
    Bladder outflow obstruction
    Bladder perforation
    Bladder wall calcification
    Bone marrow depression
    Bronchospasm
    Cardiac failure
    Cellulitis
    Chills
    Cholangitis
    Cholecystitis
    Cough
    Cystitis
    Dermatitis
    Diarrhoea
    Dyspnoea
    Dysuria
    Elevation of liver enzymes
    Eosinophilia
    Erythrocytopenia
    Exanthema
    Extravasation necrosis
    Febrile neutropenia
    Flushing
    Gastro-intestinal symptoms
    Glomerulopathy
    Granulocytopenia
    Haematuria
    Haemolytic anaemia
    Haemolytic uraemic syndrome
    Haemorrhagic cystitis
    Hepatic disorders
    Hepatic veno-occlusive disease
    Hypersensitivity reactions including anaphylaxis
    Hypertension
    Hypotension
    Impaired renal function
    Increased bleeding tendency
    Increased urinary frequency
    Infections
    Injection site reactions
    Interstitial lung disease
    Interstitial pneumonia
    Jaundice
    Lethargy
    Leucopenia
    Liver function disturbances
    Malaise
    Microangiopathic haemolytic anaemia syndrome
    Mucositis
    Muscle necrosis
    Myelodysplastic syndrome
    Nausea
    Nephropathy
    Nephrotoxicity
    Neutropenia
    Nocturia
    Oedema
    Palmar-plantar erythrodysaesthesia
    Pancytopenia
    Phlebitis
    Pneumonitis
    Pollakiuria
    Proteinuria
    Pruritus
    Pulmonary fibrosis
    Pulmonary hypertension
    Pulmonary oedema
    Pulmonary toxicity
    Pulmonary veno-occlusive disease (PVOD)
    Pyrexia
    Renal failure
    Sepsis
    Serum creatinine increased
    Shock
    Skin reactions
    Stomatitis
    Thrombocytopenia
    Thrombosis
    Thrombotic thrombocytopenic purpura
    Urethral stenosis
    Vomiting
    Weakness

    Overdosage

    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 ).

    Further Information

    Last Full Review Date: June 2019

    Reference Sources

    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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