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Intravesical Chemotherapy Pregnancy: There are no data from the use of mitomycin in pregnant women. Studies in animals have shown reproductive toxicity. 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. Breastfeeding is contraindicated and must be discontinued during treatment. Women of childbearing potential have to use effective contraception or practise sexual abstinence during chemotherapy and for 6 months afterwards.

Mitomycin C

Brand names: Mitomycin-C Kyowa

Mitomycin C is a cytotoxic antibiotic given as intravesical instillation to reduce recurrence of non-muscle-invasive bladder cancer.

Adult dose

Dose: 40 mg instilled into the bladder per instillation (the content of one 40 mg vial) for relapse prevention in superficial urinary bladder carcinoma after transurethral resection
Route: Intravesical instillation (after reconstitution, by catheter at low pressure)
Frequency: Once weekly unless otherwise specified; instillations every 2 weeks, every month or 3 monthly can also be used - the specialist decides the regimen, frequency and duration
VERBATIM UK SPC §4.2 (Mitomycin medac 40 mg powder and solvent for intravesical solution): '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.' §4.1: 'indicated as intravesical administration for relapse prevention in adults with superficial urinary bladder carcinoma after transurethral resection.' METHOD, VERBATIM: '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.' 'After 2 hours the patient should void the instilled solution, preferably in a sitting position.' '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.' 'Mitomycin medac must be administered by physicians experienced in this therapy, only if strictly indicated.' No maximum dose is printed, so none is given. Elderly: 'Insufficient data from clinical studies are available concerning the use of mitomycin in patients ≥ 65 years of age.' Paediatric: 'The safety and efficacy of Mitomycin medac in children have not been established. No data are available.'

Dose adjustments

Renal

UK SPC §4.2: 'The medicinal product should be used with caution in patients with renal or hepatic impairment.' No dose figure is given. §4.4: close monitoring of renal function is recommended; stop therapy if there are indications of renal dysfunction (nephrotoxicity).

Hepatic

UK SPC §4.2: 'The medicinal product should be used with caution in patients with renal or hepatic impairment.' No dose figure is given.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via MHRA Products — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients
  • Breastfeeding
  • Bladder wall perforation
  • Cystitis

Side effects

  • Common (intravesical): allergic skin rash, contact dermatitis, palmar-plantar erythema, pruritus
  • Common (intravesical): cystitis (possibly haemorrhagic), dysuria, nocturia, pollakiuria, haematuria, local irritation of the bladder wall
  • Very rare or not known: necrotising cystitis, allergic (eosinophilic) cystitis, stenosis of the efferent urinary tract, reduced bladder capacity, bladder wall calcification, bladder wall fibrosis, bladder perforation
  • Extravasation: bladder perforation, (fat) tissue necrosis of the surrounding area, vesical fistula, abscesses
  • Very rare systemic effects after intravesical use: leukocytopenia, thrombocytopenia, interstitial lung disease, nausea, vomiting, diarrhoea, increased transaminases, alopecia, renal dysfunction, fever

Interactions

  • Possible interactions under systemic therapy: myelotoxic interactions with other bone marrow-toxic treatment (other cytotoxic medicinal products, radiation)
  • Vinca alkaloids or bleomycin may reinforce pulmonary toxicity
  • Increased risk of haemolytic-uraemic syndrome with intravenous mitomycin plus 5-fluorouracil or tamoxifen
  • Pyridoxine hydrochloride (vitamin B6) resulted in loss of mitomycin effect in animal experiments
  • No live vaccines in connection with mitomycin treatment (increased risk of infection by the live vaccine)
  • The cardiotoxicity of doxorubicin may be reinforced by mitomycin

Monitoring

  • Symptoms of cystitis: treat symptomatically with local anti-inflammatories and analgesics; therapy can usually be continued, if necessary at a reduced dose
  • Possible extravasation: pelvic or abdominal pain refractory to simple analgesia, which can appear straight after instillation or weeks to months later
  • Bone marrow toxicity: suppression may manifest after a delay, most strongly after 4-6 weeks, and can accumulate with prolonged use
  • Pulmonary symptoms not attributable to the underlying disease: stop therapy immediately
  • Stop therapy immediately if symptoms of haemolysis or indications of renal dysfunction (nephrotoxicity) occur; close monitoring of renal function is recommended
  • Patients should wash hands and genital area after micturition, especially after the first micturitions following administration

Clinical monograph

How it works

It acts as a DNA alkylating and cross-linking agent, inhibiting DNA synthesis and proliferation of malignant urothelial cells.

Prescribing in practice

  • It is a vesicant and tissue irritant; extravasation or instillation in the presence of bladder perforation can cause serious local injury, so avoid use where perforation is suspected.
  • Local effects such as chemical cystitis and, with skin contact, dermatitis are common and require careful handling and patient hygiene advice.
  • It must be prepared and administered by appropriately trained staff using cytotoxic precautions in line with the SPC.

Monitoring

Monitor for chemical cystitis and local toxicity after instillation, with cystoscopic surveillance to assess tumour recurrence over time.

Counselling the patient

  • Empty your bladder after the instillation dwell time and wash the genital skin to limit irritation.
  • Mild burning or frequency when passing urine is common for a short period; report severe or persistent symptoms.
  • Follow the advice given about fluid intake and handling of urine after treatment.

Evidence & guidelines

Intravesical chemotherapy with mitomycin C is an established adjunct for non-muscle-invasive bladder cancer, supported by NICE guidance.

Reference: NICE NG2 (Bladder Cancer); EAU Bladder Cancer Guidelines 2024; Sylvester et al. meta-analysis (2004); Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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