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 and/or 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. Each mL of reconstituted solution will contain 0.5 mg mitomycin and have a pH between 6.0 and 8.0.
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
Topical Interferon Alfa 2b and Mitomycin C in Conjunctival-Corneal Intraepithelial Neoplasia [Active, not recruiting]
The purpose of this study is to evaluate the therapeutic efficacy of interferon alfa 2b and
topical mitomycin C in patients with diagnosis of conjunctival-corneal intraepithelial
Intravesical Adjuvant Electromotive Mitomycin-C [Completed]
In laboratory and clinical studies, intravesical electromotive drug administration increased
mitomycin bladder uptake, improving clinical efficacy in high-risk non-muscle invasive
urothelial bladder cancer. The investigators' aim was to compare transurethral resection of
bladder tumor and adjuvant intravesical electromotive mitomycin with transurethral resection
and adjuvant intravesical passive diffusion mitomycin and transurethral resection alone in
patients with primary stage pTa-pT1 and grade G1-G2 urothelial bladder cancer Patients will
be randomly assigned to: transurethral resection alone, transurethral resection and
adjuvant intravesical 40 mg passive diffusion mitomycin dissolved in 50 ml sterile water
infused over 60 minutes once a week for 6 weeks, or transurethral resection and adjuvant
intravesical 40 mg electromotive mitomycin dissolved in 100 ml sterile water with 23 mA
pulsed electric current for 30 minutes once a week for 6 weeks. Patients in the intravesical
adjuvant electromotive and passive diffusion mitomycin groups who are disease-free 3 months
after induction treatment, will be scheduled to receive monthly intravesical instillation
for 10 months, with the same dose and methods of infusion as initial assigned treatment. All
patients will be assessed for safety. The investigators' primary endpoints are recurrence
rate and disease-free interval. Analyses will be done by intention to treat.
Study of Mitomycin C and Nasal Splint to Treat Nasal Synechiae [Completed]
This study evaluates whether Mitomycin C is an effective alternative to septal splints in
the treatment of nasal synechiae.
Veliparib With or Without Mitomycin C in Treating Patients With Metastatic, Unresectable, or Recurrent Solid Tumors [Active, not recruiting]
This phase I trial studies the side effects and best dose of veliparib when given with or
without mitomycin C in treating patients with solid tumors that have spread to other places
in the body, cannot be removed by surgery or have come back. Veliparib may stop the growth
of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in
chemotherapy, such as mitomycin C, work in different ways to stop the growth of tumor cells,
either by killing the cells, by stopping them from dividing, or by stopping them from
spreading. Giving veliparib together with mitomycin C may kill more tumor cells.
Ologen Collagen Matrix Safety and Effective Comparison With Mitomycin-C(MMC) in Glaucoma Surgery [Completed]
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