Mitomycin

Pronunciation: my-toe-MY-sin.

Generic name
mitomycin (mitomycin-C)
Drug class
Antitumour antibiotic / alkylating chemotherapy agent
Form
Powder for injection, 2 mg/5 mg/10 mg/20 mg/40 mg per vial (systemic); pyelocalyceal gel kit (Jelmyto); 0.2 mg lyophilized vial for topical ophthalmic solution (Mitosol)
Route
Intravenous injection/infusion; intravesical (bladder) instillation; pyelocalyceal (kidney/ureter) instillation (Jelmyto); topical ophthalmic (Mitosol)
Legal status
Prescription-only; hospital or specialist procedural administration only in all formulations reviewed

Supply Rules Vary

Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand

Australia: MITOCIN (6), MITOMYCIN ACCORD (6), MITOMYCIN OMEGAPHARM (6) · Full directory

What mitomycin (mitomycin-C) is and how it works

Mitomycin is a prescription chemotherapy antibiotic given only in a hospital or specialist setting. As a systemic injection, it treats certain advanced cancers (in combination with other chemotherapy) and is also instilled directly into the bladder for superficial bladder cancer. Two other real, distinctly-approved mitomycin products exist: Jelmyto, a gel instilled into the kidney/ureter for a specific type of upper urinary tract cancer, and Mitosol, a much lower-concentration topical solution applied during eye surgery for glaucoma. These three products are never interchangeable. (1) (2)

Systemic mitomycin carries the FDA's strongest safety warning (a boxed warning) covering serious bone marrow suppression and hemolytic uremic syndrome (HUS), a rare but serious kidney complication. Because of these risks, mitomycin is given only by a cancer specialist with close blood test monitoring, in a facility equipped to manage complications. Mitosol, used during eye surgery, is a completely different, much more dilute product with a different, much less severe risk profile focused on the eye (it carries no boxed warning). Your care team will explain which mitomycin product applies to your situation and why.

Mechanism of action: how mitomycin (mitomycin-C) works

Mitomycin is an antibiotic isolated from Streptomyces (verticillus/caespitosus strains depending on source) that is activated in tissues to an alkylating agent, forming cross-links with DNA and inhibiting DNA synthesis; cellular RNA and protein synthesis may also be suppressed at higher concentrations. The degree of mitomycin-induced cross-linking correlates with the guanine and cytosine content of DNA. (2) (5)

What mitomycin (mitomycin-C) is used for

Disseminated adenocarcinoma of the stomach, pancreas, or colon (systemic injection)

Palliative treatment, in combination with other chemotherapy agents, for disseminated adenocarcinoma of the stomach or pancreas (US) or as an adjunct to surgery, radiation, or chemotherapy for adenocarcinoma of the stomach and colon (Canada), when other treatment modalities have failed. Not recommended as a single-agent, primary therapy. (1) (5)

Advanced/metastatic breast cancer, non-small cell bronchial carcinoma, pancreatic carcinoma (systemic injection -- UK/New Zealand)

Used intravenously as monotherapy or combined cytostatic chemotherapy for advanced metastatic gastric carcinoma and advanced/metastatic breast cancer, and in combined chemotherapy for non-small cell bronchial carcinoma and advanced pancreatic carcinoma. This broader combination-therapy indication list is confirmed in the UK and New Zealand sources reviewed. (4) (7)

Superficial bladder cancer (intravesical instillation)

As a single agent, topical (intravesical) therapy for superficial (no invasion beyond the lamina propria) transitional cell carcinoma of the urinary bladder, and to prevent relapse after transurethral resection -- effective both in patients with no prior intravesical chemotherapy and those who have failed prior therapy. (1) (5) (4)

Low-grade upper tract urothelial cancer -- Jelmyto (United States, distinct product)

Jelmyto (mitomycin) for pyelocalyceal solution is a separate, FDA-approved gel formulation indicated for adult patients with low-grade upper tract urothelial cancer (LG-UTUC). It is instilled as a chilled liquid directly into the renal pelvis/ureter, where it forms a gel at body temperature and remains for 4-6 hours. It is for pyelocalyceal use only -- never intravenous, topical, or oral use. (3)

Adjunct to glaucoma filtration surgery -- Mitosol (United States, distinct product)

Mitosol is a separate, FDA-approved, much more dilute (0.2 mg/mL) topical ophthalmic formulation used as an adjunct to ab externo glaucoma filtration surgery (trabeculectomy), applied via saturated sponges to the surgical site for a defined 2-minute exposure. It is not intended for intraocular administration. (2)

Before taking mitomycin (mitomycin-C)

Do not take / not appropriate for

  • Do not receive mitomycin (any formulation) if you have had an allergic (hypersensitivity) reaction to it. (all confirmed markets) (1) (4)
  • Systemic mitomycin is contraindicated if you have thrombocytopenia, leukopenia, a coagulation disorder, or an increased bleeding tendency from another cause. (all confirmed markets) (1) (5)
  • Intravesical (bladder) mitomycin is contraindicated if the bladder wall is perforated. (United Kingdom, New Zealand) (4) (7)
  • Mitosol is contraindicated in women who are or may become pregnant during therapy (Pregnancy Category X). (United States) (2)
  • Mitomycin (all systemic formulations) is contraindicated during breastfeeding. (United Kingdom, New Zealand) (4) (7)

Tell your clinician about

  • Any personal history of low platelet count, low white blood cell count, or a bleeding/clotting disorder.
  • Any history of kidney disease -- systemic mitomycin should not be given if your serum creatinine is above a certain threshold.
  • Any history of lung disease, or if you are having surgery under high oxygen concentrations.
  • If you are pregnant, trying to become pregnant, or breastfeeding -- mitomycin (in every formulation reviewed) carries real teratogenic/mutagenic risk.
  • If you are male and being treated with systemic mitomycin -- fertility preservation (sperm banking) may be worth discussing given a real risk of irreversible infertility.
  • All other medicines you take, especially other chemotherapy agents, vinca alkaloids, bleomycin, fluorouracil, or tamoxifen.
  • Any recent or planned vaccinations, especially live vaccines.
(1) (4) (7)

How to take mitomycin (mitomycin-C)

  • Mitomycin, in every formulation, is given only by trained healthcare professionals in a hospital or specialist procedural setting -- it is never a medicine you take or apply yourself at home.
  • Systemic mitomycin is given as an intravenous injection or infusion through a properly functioning IV line; extravasation (leakage into surrounding tissue) causes severe tissue damage and must be prevented and managed immediately by the treatment team.
  • Intravesical mitomycin is instilled into the bladder through a catheter and retained for a set time before being drained.
  • Jelmyto is instilled as a chilled liquid directly into the kidney/ureter by a urologist, where it gels and remains in place for a defined period.
  • Mitosol is applied to the surgical site during eye surgery by the operating ophthalmic surgeon for a strictly defined, brief exposure time.
(1) (4) (2)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6) (7) (8)

Missed dose

Mitomycin treatment is scheduled and administered by your care team as part of a defined chemotherapy or procedural protocol -- there is no self-directed missed-dose rule. Contact your treatment team if a scheduled appointment needs to be rescheduled.

Overdose

Because mitomycin is administered only by healthcare professionals under close monitoring, overdose is managed by the treatment team, typically with intensive supportive care and blood count/renal/pulmonary monitoring. Contact your regional poison control centre or emergency services for any suspected overdose. (5)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Nausea and vomiting -- very common with systemic mitomycin.

What to notice: Nausea and vomiting -- very common with systemic mitomycin.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (7)

Bone marrow suppression (low blood counts) -- occurs in up to 65% of patients receiving systemic mitomycin.

What to notice: Bone marrow suppression (low blood counts) -- occurs in up to 65% of patients receiving systemic mitomycin.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (4) (7)

Mucositis, stomatitis, diarrhea, anorexia -- reported with systemic mitomycin.

What to notice: Mucositis, stomatitis, diarrhea, anorexia -- reported with systemic mitomycin.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (7)

Bladder irritation (dysuria, cystitis, hematuria, urinary frequency) -- common with intravesical instillation.

What to notice: Bladder irritation (dysuria, cystitis, hematuria, urinary frequency) -- common with intravesical instillation.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (5)

Local eye reactions (hypotony, corneal reactions, blebitis) -- the most frequent adverse reactions to Mitosol, occurring locally at the surgical site.

What to notice: Local eye reactions (hypotony, corneal reactions, blebitis) -- the most frequent adverse reactions to Mitosol, occurring locally at the surgical site.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Ureteric obstruction, flank pain, urinary tract infection, hematuria -- most common adverse reactions with Jelmyto (ureteric obstruction in 58% of patients).

What to notice: Ureteric obstruction, flank pain, urinary tract infection, hematuria -- most common adverse reactions with Jelmyto (ureteric obstruction in 58% of patients).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (3)

Serious warnings

Bone marrow suppression (thrombocytopenia, leukopenia) — boxed_warning

Symptoms: Unusual bleeding or bruising, fever, sore throat, or signs of infection, which can occur anytime within 8 weeks of starting systemic mitomycin (average onset around 4 weeks).

Action: This is the most common and severe toxicity of systemic mitomycin and is closely monitored by your care team with weekly blood counts. Your treatment team will pause or adjust therapy based on these results -- contact your care team immediately if you notice unusual bleeding, bruising, or signs of infection between visits. (1) (5) (4)

Hemolytic uremic syndrome (HUS) — boxed_warning

Symptoms: Fatigue, pale skin, easy bruising, reduced urination, swelling, or confusion -- signs of the underlying red blood cell breakdown and kidney failure that characterise this syndrome.

Action: This is a serious, often fatal complication of systemic mitomycin (approximately 52% mortality in reported cases), more common at higher cumulative doses. Your care team monitors kidney function and blood counts specifically to catch this early. Seek immediate medical attention for any of these symptoms. (1) (5) (4)

Pulmonary toxicity — high caution

Symptoms: Shortness of breath and a dry, nonproductive cough.

Action: Tell your care team immediately if these occur -- mitomycin-related lung toxicity can often be reversed if caught early and treatment is stopped, sometimes with steroid treatment to help symptoms resolve. (5) (4) (7)

Extravasation and tissue necrosis at the injection site — high caution

Symptoms: Pain, redness, swelling, or a burning sensation at or near the IV site, sometimes appearing weeks after the injection.

Action: This is a real, serious risk of IV administration even without an obvious problem noticed at the time. Your treatment team will monitor the injection site and treat extravasation promptly (e.g. with sodium bicarbonate and dexamethasone) if it occurs; severe cases have required skin grafting. (4) (7) (1)

Ureteric obstruction (Jelmyto only) — high caution

Symptoms: Flank pain, reduced urine output, or signs of a urinary tract infection.

Action: This occurred in 58% of patients receiving Jelmyto in clinical trials and required a ureteral stent or alternative procedure in most of those cases. Your urologist monitors closely for this and will manage it promptly if it occurs. (3)

Corneal or scleral damage and vision changes (Mitosol only) — high caution

Symptoms: Eye pain, vision changes, or unusual redness after glaucoma surgery.

Action: Mitosol is cytotoxic and, if used at higher than approved concentration or for longer than the approved exposure time, can cause corneal or scleral thinning or perforation. Your ophthalmic surgeon controls concentration and exposure time precisely to minimise this risk; report any new eye symptoms after surgery promptly. (2)

Interactions

  • Other bone-marrow-toxic (myelotoxic) chemotherapy agents and radiation therapy: additive bone marrow suppression risk. (4) (7)
  • Vinca alkaloids: acute shortness of breath and severe bronchospasm reported when given to patients who previously or simultaneously received mitomycin. (5) (4)
  • Bleomycin: may reinforce pulmonary toxicity in combination with mitomycin. (4)
  • Fluorouracil or tamoxifen: increased risk of hemolytic uremic syndrome when combined with mitomycin. (4) (7)
  • Doxorubicin (Adriamycin): cardiotoxicity of doxorubicin may be reinforced by mitomycin. (7)
  • Live vaccines: should be avoided during mitomycin treatment due to increased infection risk in an immunocompromised patient; wait at least 3 months after the last chemotherapy dose before live-virus vaccination. (4) (7)
  • Pyridoxine (vitamin B6): animal experiments showed loss of mitomycin's effect with concomitant high-dose pyridoxine. (7)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Systemic mitomycin should not be used during pregnancy; it has mutagenic, teratogenic, and carcinogenic effects confirmed in animal studies, and safe use in pregnant women has not been established. Mitosol is specifically contraindicated in women who are or may become pregnant during therapy (US Pregnancy Category X). (1) (2) (3) (4) (5) (6) (7) (8)

Breastfeeding

Breastfeeding should be discontinued before starting mitomycin therapy (systemic formulation); it is a contraindication in the UK and New Zealand labels reviewed. Mitosol is also not recommended during breastfeeding given the potential for serious adverse reactions in nursing infants. (1) (2) (3) (4) (5) (6) (7) (8)

Fertility

Female patients of reproductive age should use contraception during treatment and for 6 months afterward. Male patients are advised not to father a child during treatment and for 6 months afterward, and to consider sperm preservation before starting therapy given a real risk of irreversible infertility. (1) (2) (3) (4) (5) (6) (7) (8)

Children

Safety and efficacy of systemic mitomycin in children aged 0-17 years have not been established. Pediatric safety and effectiveness of Mitosol have also not been established. (1) (2) (3) (4) (5) (6) (7) (8)

Elderly

Elderly patients may have reduced physiological function and more protracted bone marrow suppression; mitomycin should be administered with special caution and close monitoring in this population. No overall differences in Mitosol's safety/effectiveness were observed between elderly and younger patients. (1) (2) (3) (4) (5) (6) (7) (8)

Renal_impairment

Systemic mitomycin should not be given to patients with a serum creatinine greater than 1.7 mg% (US), and is not recommended in patients with renal impairment more broadly (New Zealand). (1) (2) (3) (4) (5) (6) (7) (8)

Hepatic_impairment

Not recommended in patients with hepatic impairment due to a lack of efficacy and safety data in this group (New Zealand). (1) (2) (3) (4) (5) (6) (7) (8)

Source_ids

US-DAILYMED-MITOMYCIN-INJECTION-2026,US-FDA-MITOSOL-LABEL-2012,UK-EMC-MITOCIN-SMPC-2026,NZ-MEDSAFE-MITOMYCIN-DS-2026 (1) (2) (3) (4) (5) (6) (7) (8)

Monitoring

Before starting

  • Complete blood count
  • Renal function test
  • Pulmonary function test if pre-existing lung disease is suspected
  • Liver function test
  • Assessment of pregnancy status and fertility-preservation options

During treatment

  • Weekly blood counts (platelets, white blood cells, differential, hemoglobin) during systemic therapy and for at least 7-8 weeks after.
  • Close monitoring of renal function, especially at higher cumulative doses, to catch early signs of hemolytic uremic syndrome.
  • Monitoring for signs of pulmonary toxicity (shortness of breath, dry cough).
  • Monitoring the IV injection site for signs of extravasation.
  • For Jelmyto: monitoring for ureteric obstruction and renal function.
  • For Mitosol: post-operative monitoring of intraocular pressure, corneal/scleral integrity, and lens changes.
(5) (7)

Storage

Mitomycin (all formulations) is stored and handled exclusively by hospital pharmacy and clinical staff according to the specific product's storage requirements; it is never stored or handled by patients at home.

Professional information

Clinician-facing context only, sourced from the current US, UK, Canadian, Australian, and New Zealand sources reviewed; verify against the current full label before prescribing or administering, and note the real distinctions between the three mitomycin products described above.

United States

Indication: Systemic: disseminated gastric/pancreatic adenocarcinoma (combination, palliative); intravesical bladder carcinoma. Jelmyto: LG-UTUC. Mitosol: glaucoma filtration surgery adjunct.

Dose summary: Systemic: 20 mg/m2 IV single dose every 6-8 weeks. Jelmyto: per urologist-directed pyelocalyceal protocol. Mitosol: 0.2 mg/mL, single 2-minute topical application.

Renal context: Systemic mitomycin should not be given if serum creatinine >1.7 mg%. (1) (3) (2)

United Kingdom / New Zealand

Indication: Systemic: advanced gastric/breast cancer, non-small cell bronchial carcinoma, pancreatic carcinoma (combination); intravesical bladder carcinoma relapse prevention.

Dose summary: IV 10-20 mg/m2 every 6-8 weeks (or alternative protocols per indication); maximum cumulative dose 60 mg/m2. Intravesical 20-40 mg weekly for 8-12 weeks, or 4-10 mg 1-3 times weekly.

Renal context: Not recommended in patients with renal impairment (New Zealand); close renal monitoring required given HUS risk above 30 mg/m2. (4) (7)

Canada, Australia

Indication: Canada: palliative adjunct for adenocarcinoma of the stomach and colon; intravesical superficial bladder carcinoma. Australia: multiple registered generic/branded injectable products for standard oncology indications.

Dose summary: Dosing follows the same core principle as other markets: IV bolus at protocol-specified intervals, or intravesical instillation for bladder cancer, with dose held/reduced for bone marrow, renal, or pulmonary toxicity.

Renal context: Used with extreme caution in patients with significant renal impairment (Canada). (5) (6)

Mechanism of action

Overdose note

No specific antidote; management is supportive, with intensive monitoring of blood counts, renal function, and pulmonary status. Contact a regional poison control centre for guidance on any suspected overdose. (2) (5)

Frequently asked questions

Does mitomycin carry a boxed warning?

Yes -- the systemic injectable formulation of mitomycin carries a real FDA boxed warning covering bone marrow suppression (the most common and severe toxicity) and hemolytic uremic syndrome (HUS), a serious, often fatal kidney complication most common at higher cumulative doses. The boxed warning also requires that mitomycin be given only under the supervision of a physician experienced in cancer chemotherapy. Health Canada's monograph contains an equivalent CAUTION statement that also names pulmonary toxicity as a reason to stop or reduce treatment. Mitosol, the topical eye-surgery formulation, does NOT carry a boxed warning and has a much more limited, localised risk profile. (1) (5) (2)

Are Jelmyto, Mitosol, and regular mitomycin injection the same medicine?

They all contain the active ingredient mitomycin, but they are three distinct, non-interchangeable, separately FDA-approved products. Systemic mitomycin injection treats certain cancers via IV or bladder instillation and carries the boxed warning described above. Jelmyto is a specific gel formulation instilled into the kidney/ureter for a particular type of urinary tract cancer (low-grade upper tract urothelial cancer), with its own prominent risk of ureteric obstruction. Mitosol is a much more dilute topical solution used briefly during eye surgery for glaucoma, with a completely different, eye-specific risk profile and no boxed warning. (1) (3) (2)

What is hemolytic uremic syndrome (HUS) and how serious is it?

HUS is a serious complication of mitomycin chemotherapy involving the breakdown of red blood cells (microangiopathic hemolytic anemia), low platelet counts, and kidney failure that can become irreversible. It has been associated with a high mortality rate (approximately 52% in reported cases) and occurs mostly at higher cumulative mitomycin doses (60 mg or more in the US label; above 30 mg/m2 in the UK/New Zealand labels). This is why your care team closely monitors kidney function and blood counts throughout systemic mitomycin treatment. (1) (5) (4)

Is mitomycin authorised the same way across the European Union?

For its standard cancer indications, mitomycin is authorised nationally by individual EU member states' own medicines regulators rather than through one single EMA centralised marketing authorisation -- similar to many older, genericised chemotherapy agents. Separately, mitomycin holds a real EMA orphan drug designation specifically for anal cancer, which is a distinct regulatory fact and not the same as a full EU-wide marketing authorisation for that use. (8)

What is the mechanism of action of mitomycin (mitomycin-C)?

Mitomycin is an antibiotic isolated from Streptomyces (verticillus/caespitosus strains depending on source) that is activated in tissues to an alkylating agent, forming cross-links with DNA and inhibiting DNA synthesis; cellular RNA and protein synthesis may also be suppressed at higher concentrations. The degree of mitomycin-induced cross-linking correlates with the guanine and cytosine content of DNA. (2) (5)

What is the generic name of Mitomycin?

The generic name is mitomycin (mitomycin-C). (1) (4)

What class of drug is mitomycin (mitomycin-C)?

Mitomycin is classed as: Antitumour antibiotic / alkylating chemotherapy agent. (1) (4)

References

  1. Mitomycin for Injection, USP -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information · United States · accessed 2026-07-31 · source 1
  2. Mitosol (mitomycin for solution) -- full prescribing information, NDA 022572, revised 01/2012U.S. Food and Drug Administration, full prescribing information (Mobius Therapeutics LLC) · United States · accessed 2026-07-31 · source 2
  3. JELMYTO (mitomycin) for pyelocalyceal solution -- full prescribing information, approved 2020-04-15U.S. Food and Drug Administration / DailyMed (NIH), full prescribing information (UroGen Pharma) · United States · accessed 2026-07-31 · source 3
  4. Mitocin 20 mg, powder for solution for injection/infusion or intravesical use -- Summary of Product Characteristics (SmPC)electronic medicines compendium (emc), United Kingdom · United Kingdom · accessed 2026-07-31 · source 4
  5. MITOMYCIN FOR INJECTION, USP 20 mg -- Product Monograph, prepared 2022-10-12Health Canada / Hikma Canada Limited, Product Monograph · Canada · accessed 2026-07-31 · source 5
  6. Mitomycin products -- ARTG entries (MITOCIN 20mg, ARTG 370360; MITOMYCIN ACCORD 2mg/10mg/20mg, ARTG 243572/243592; MITOMYCIN OMEGAPHARM 20mg, ARTG 243554)Therapeutic Goods Administration (TGA), Australia · Australia · accessed 2026-07-31 · source 6
  7. Mitomycin, Powder for Injection, 2 mg/10 mg/20 mg per vial -- New Zealand Data Sheet, Version 2.0Medsafe (New Zealand regulator) -- official New Zealand Data Sheet · New Zealand · accessed 2026-07-31 · source 7
  8. EU national medicines registers (mitomycin nationally authorised); EU/3/20/2343 orphan designation for anal cancerEuropean Medicines Agency (EMA) · European Union · accessed 2026-07-31 · source 8

Brand names by country

Single-ingredient mitomycin (mitomycin-C) names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • MUTAMYCIN5 mg0mL, 40 mg/80mL · accord biopharma inc.

United Kingdom

  • Mitocin (4)current licensed product · 20 mg powder for solution for injection/infusion or intravesical use · See current emc SmPC

Canada

  • Mitomycin for Injection, USP (5)current product monograph · 20 mg/vial · Hikma Canada Limited

Australia

  • MITOCIN (6)current register product · 20 mg vial · See current ARTG entry 370360
  • MITOMYCIN ACCORD (6)current register product · 2 mg, 10 mg, 20 mg vial · Accord Healthcare
  • MITOMYCIN OMEGAPHARM (6)current register product · 20 mg vial · Omegapharm

New Zealand

  • Mitomycin (Teva) (7)current registered product · 2 mg, 10 mg, 20 mg vial · See current Medsafe data sheet
View brands in additional countries.

European Union

Mitomycin (nationally authorised injectable products, brand varies by member state) (8)

This page provides general reference information about mitomycin and is not a substitute for advice from the oncology, urology, or ophthalmic surgical team managing your treatment. Mitomycin has genuinely different approved products and risk profiles depending on the formulation; all dosing, administration, and treatment decisions must be made with your treating specialist team.

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