Mitomycin should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available.
Bone marrow suppression, notably thrombocytopenia and leukopenia, which may contribute to overwhelming infections in an already compromised patient, is the most common and severe of the toxic effects of mitomycin (see WARNINGS and ADVERSE REACTIONS Sections).
Hemolytic Uremic Syndrome (HUS) a serious complication of chemotherapy, consisting primarily of microangiopathic hemolytic anemia, thrombocytopenia, and irreversible renal failure, has been reported in patients receiving systemic mitomycin. The syndrome may occur at any time during systemic therapy with mitomycin as a single agent or in combination with other cytotoxic drugs; however, most cases occur at doses ≥ 60 mg of mitomycin. Blood product transfusion may exacerbate the symptoms associated with this syndrome.
The incidence of the syndrome has not been defined.
Mitomycin (also known as mitomycin-C) is an antibiotic isolated from the broth of Streptomyces caespitosus which has been shown to have antitumor activity. The compound is heat stable, has a high melting point, and is freely soluble in organic solvents. Mitomycin for Injection is a sterile dry mixture of mitomycin and mannitol, which, when reconstituted with Sterile Water for Injection, provides a solution for intravenous administration. Each vial contains either mitomycin 5 mg and mannitol 10 mg, or mitomycin 20 mg and mannitol 40 mg, or mitomycin 40 mg and mannitol 80 mg.
Mitomycin (MITOMYCIN) is indicated for the following:
Mitomycin for Injection is not recommended as single-agent, primary therapy. It has been shown to be useful in the therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed. Mitomycin is not recommended to replace appropriate surgery and/or radiotherapy.
Published Studies Related to Mitomycin
Effects of mitomycin-C on tear film, corneal biomechanics, and surface
irregularity in mild to moderate myopic surface ablation: preliminary results. 
DESIGN: Double-masked randomized clinical trial... CONCLUSION: Use of MMC in PRK did not appear to contribute significantly to
Inhibition of epidural fibrosis after microendoscopic discectomy with topical
application of mitomycin C: a randomized, controlled, double-blind trial. 
discectomy (MED)... CONCLUSIONS: Although no benefit was observed clinically, the authors observed a
Postoperative treatment with topical diclofenac versus topical dexamethasone
after combined phacotrabeculectomy with mitomycin C. 
(Voltaren Ophthalmic) after combined phacotrabeculectomy with mitomycin C... CONCLUSIONS: In this preliminary study, diclofenac sodium is at least as good as
Electromotive instillation of mitomycin immediately before transurethral resection for patients with primary urothelial non-muscle invasive bladder cancer: a randomised controlled trial. [2011.09]
BACKGROUND: The clinical effect of intravesical instillation of chemotherapy immediately after transurethral resection of bladder tumours (TURBT) has recently been questioned, despite its recommendation in guidelines. Our aim was to compare TURBT alone with immediate post-TURBT intravesical passive diffusion (PD) of mitomycin and immediate pre-TURBT intravesical electromotive drug administration (EMDA) of mitomycin in non-muscle invasive bladder cancer... INTERPRETATION: Intravesical EMDA mitomycin before TURBT is feasible and safe; moreover, it reduces recurrence rates and enhances the disease-free interval compared with intravesical PD mitomycin after TURBT and TURBT alone. FUNDING: None. Copyright (c) 2011 Elsevier Ltd. All rights reserved.
Preoperative radiotherapy with capecitabine and mitomycin C in locally advanced rectal carcinoma. [2011.09]
PURPOSE: To evaluate the efficacy and safety of preoperative radiotherapy with capecitabine and mitomycin C in patients with locally advanced rectal cancer... CONCLUSION: Preoperative chemoradiation with capecitabine and mitomycin C appeared to be effective with low toxicity in patients with locally advanced rectal cancer.
Clinical Trials Related to Mitomycin
Study of Mitomycin C and Nasal Splint to Treat Nasal Synechiae [Recruiting]
This study evaluates whether Mitomycin C is an effective alternative to septal splints in
the treatment of nasal synechiae.
Recurrent Pterygium Surgery With Mitomycin C Application Using Limbal Conjunctival Versus Amniotic Membrane [Recruiting]
The purpose of this trial is to compare two techniques for the treatment of recurrent
pterygium: intraoperative mitomycin C plus limbal conjunctival autograft transplantation
versus intraoperative mitomycin C plus amniotic membrane graft transplantation.
Surgery and Oxaliplatin or Mitomycin C in Treating Patients With Primary Colorectal Tumors or Tumors of the Appendix [Recruiting]
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and mytomycin C, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. Heating a chemotherapy solution and infusing it directly into the
abdomen may kill more tumor cells. Giving these treatments after surgery may kill any tumor
cells that remain after surgery.
PURPOSE: This randomized phase II trial is studying the side effects and how well giving
oxaliplatin or mitomycin C directly into the abdomen after surgery works in treating
patients with primary colorectal tumors or tumors of the appendix.
A Phase II Study of Intra-arterial Chemotherapy With Cisplatin and Mitomycin-C in Patients With Hepatocellular Carcinoma [Recruiting]
This study is for people with cancer of the liver that cannot be completely removed by
surgery. This study involves giving the drugs mitomycin-C and cisplatin, into an artery in
the liver. Mitomycin-C is a drug that has been approved by the FDA to treat cancer of the
stomach and pancreas. Mitomycin-C is a drug that causes cancer cells to die and prevents
them from reproducing. Cisplatin is also a drug that has been approved by the FDA.
Cisplatin is approved to treat cancer of the testes, ovaries, lung, esophagus, bladder, head
and neck. Cisplatin is a drug that prevents cancer cells from reproducing. The purpose
of this study is to see how long it takes subjects' tumor(s) to grow after receiving the
study drugs. Another purpose of this study is to look at the side effects of this study
therapy and how long subjects survive after receiving it.
An additional purpose of this study is to see how well we can predict subjects' response to
the study therapy, based on blood and tumor tissue tests. These tests will measure the
levels of genes (the cell's blueprint) in subjects' tumors and blood. These genes affect
how people's bodies react to the cancer drugs.
Mitomycin C Versus Bacillus Calmette-Guerin in the Intravesical Treatment of Non-Muscle-Invasive Bladder Cancer Patients [Recruiting]
The purpose of this study is to compare the bladder cancer treatments, Mitomycin C (MMC) and
Bacillus Calmette Guerin (BCG), to find out which is better. In this study, the patient will
get either the Mitomycin C (MMC) or the Bacillus Calmette Guerin (BCG). They will not get
The patient had a Transurethral Resection (TUR) or an in office cystoscopy to make the
diagnosis of bladder cancer. A biopsy was done and removed any tumors the doctor saw. Even
after the doctor removes the tumors, the cancer can return. In this case, the doctor will
put medicine into the bladder to destroy cancer cell. This is called intravesical therapy.
The two most commonly used drugs for this purpose are MMC and BCG.
Both drugs have been studied for many years. They both show good results when compared to
other treatments. They have not been studied using the schedule that will be used in the
study. The doctor does not know if these two drugs are equally effective in treating the
cancer and preventing recurrence.
BCG has been studied more often than MMC. The studies have shown that a long schedule of BCG
is better than a short schedule of MMC. They have also shown that the side effects of BCG
are more intense than with MMC. A recent study showed that a new dose of MMC is better than
the old standard dose. Since the side effects of MMC occur less often, it is important to
learn whether the two drugs are equally effective. That could help us decide between the
treatments. In this study, the doctor will compare MMC and BCG when given for the same
amount of time. The doctor hopes the study will tell us which drug is more effective in
preventing the return of the cancer.
Reports of Suspected Mitomycin Side Effects
OFF Label USE (40),
Incorrect Route of Drug Administration (24),
Hepatic Failure (20),
Hepatic Cirrhosis (10),
Interstitial Lung Disease (5),
Nausea (5), more >>
Page last updated: 2014-11-30