TM Owner Accord Healthcare
Mitomycin Intravesical 40mg Vial
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Indications & Clinical Uses
- Mitomycin Intravesical 40 mg contains mitomycin, the same cytotoxic antibiotic used intravenously in cancer chemotherapy, but this presentation is prepared and licensed specifically for intravesical use - instillation directly into the bladder - and is used only for relapse prevention in adults with superficial (non-muscle-invasive) urinary bladder carcinoma after the tumour has been removed by transurethral resection (TURBT).
- This is a urology procedure, not systemic chemotherapy: mitomycin solution is passed into the empty bladder through a catheter and left in place for one to two hours before being drained.
- It must never be given intravenously, and intravenous mitomycin products must never be substituted for this intravesical presentation or vice versa - the two forms and routes are separate, non-interchangeable uses of the same molecule.
- Mitomycin Intravesical is administered only by a physician or specialist nurse experienced in the procedure, typically in a urology outpatient clinic; patients never instill it themselves.
Side Effects
- The most common side effects of intravesical Mitomycin are local to the bladder: cystitis (which may be blood-stained), pain or burning on passing urine, passing urine more often than usual, and needing to pass urine urgently.
- Allergic skin reactions, including contact dermatitis and redness or peeling of the palms and soles, are also common with repeated courses.
- Systemic side effects such as nausea, vomiting, diarrhoea, or low blood counts are very rare with intravesical use because absorption into the bloodstream is low, but they can occur, particularly if the drug leaks (extravasates) beyond the bladder wall - a known risk that can present straight after treatment or weeks to months later as pelvic pain, tissue damage, or a fistula.
- Very rarely, instillation can cause severe allergic (eosinophilic) cystitis, narrowing of the ureters, reduced bladder capacity, bladder wall fibrosis or calcification, or bladder perforation.
- Report blood in the urine that does not settle, severe pelvic pain, fever, or inability to pass urine to your urology team urgently.
Precautions & Warnings
- Mitomycin Intravesical must not be given if the bladder has been perforated, if active cystitis is present, or if there is hypersensitivity to mitomycin or any excipient; it is also contraindicated during breastfeeding.
- Before each instillation the bladder is drained by catheter and the solution is instilled slowly at low pressure to reduce the risk of the drug leaking beyond the bladder wall; patients are usually asked to change position during the one- to two-hour dwell time so the solution contacts the whole bladder lining, and to avoid excessive fluid intake immediately beforehand.
- Mitomycin is mutagenic and potentially carcinogenic, so any urine passed within about six hours of treatment should be handled with care and toilets flushed twice; men are usually advised to sit down to urinate for the rest of the treatment day to limit splashing.
- Repeated courses are monitored with periodic cystoscopy because of cumulative bladder effects.
- Safety in pregnancy and children has not been established, and this product must never be given intravenously.
Avoid Interactions
- Tell your urology team about all other medicines and any recent or planned vaccinations before starting Mitomycin Intravesical treatment.
- Using it together with other bone-marrow-suppressing (myelotoxic) drugs, or with radiotherapy, can add to the small systemic toxicity risk, so the urology team should know about any other cancer treatment being given.
- Vinca alkaloid chemotherapy or bleomycin given around the same time may increase the risk of lung toxicity, and prior or concurrent doxorubicin may increase the risk of heart toxicity if mitomycin is absorbed systemically, for example after extravasation.
- Live vaccines should be avoided during a course of treatment.
- Because absorption into the bloodstream is normally very low with intravesical use, most systemic drug interactions relevant to intravenous mitomycin are less of a concern here, but any new medicine, herbal product, or supplement should still be discussed with the treating team, and this solution must never be mixed with other drugs in the catheter or instillation set.
References
Frequently Asked Questions
Mitomycin Intravesical is a chemotherapy solution instilled directly into the bladder to help prevent early-stage bladder cancer from returning after a tumour has been surgically removed. It is a urology bladder treatment given by a specialist, not intravenous chemotherapy for the whole body.
A urologist or specialist nurse passes the mitomycin solution into your empty bladder through a catheter and leaves it in place for one to two hours before it is drained. It is repeated on a schedule set by your urology team, typically weekly at first.
The most common effects are bladder irritation: burning or pain when passing urine, needing to go more often, and sometimes blood-stained urine. Skin reactions on the hands and feet can occur with repeated courses; severe pelvic pain or fever should be reported at once.
Avoid drinking large amounts of fluid right before your instillation, since this dilutes the dose. For about six hours after treatment, flush the toilet twice after passing urine and avoid splashing, as the urine contains active drug that can irritate skin.
Your bladder is emptied by catheter, the mitomycin solution is instilled slowly, and you keep it in your bladder for one to two hours, changing position occasionally. Afterwards you pass the solution out, usually sitting down, and can go home the same day.
No. Mitomycin Intravesical is placed only in the bladder for bladder cancer and must never be given into a vein. Intravenous mitomycin is a separate systemic chemotherapy used for other cancers, and the two products and routes must never be swapped.
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