Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS Bone Marrow Toxicity This was the most common and most serious toxicity, occurring in 605 of 937 patients (64.4%).
Thrombocytopenia and/or leukopenia may occur anytime within 8 weeks after onset of therapy with an average time of 4 weeks.
Recovery after cessation of therapy was within 10 weeks.
About 25% of the leukopenic or thrombocytopenic episodes did not recover.
Mitomycin produces cumulative myelosuppression.
Integument and Mucous Membrane Toxicity This has occurred in approximately 4% of patients treated with mitomycin.
Cellulitis at the injection site has been reported and is occasionally severe.
Stomatitis and alopecia also occur frequently.
Rashes are rarely reported.
The most important dermatological problem with this drug, however, is the necrosis and consequent sloughing of tissue which results if the drug is extravasated during injection.
WARNINGS Patients being treated with mitomycin must be observed carefully and frequently during and after therapy.
The use of mitomycin results in a high incidence of bone marrow suppression, particularly thrombocytopenia and leukopenia.
Therefore, the following studies should be obtained repeatedly during therapy and for at least eight weeks following therapy: platelet count, white blood cell count, differential, and hemoglobin.
The occurrence of a platelet count below 100,000/mm 3 or a WBC below 4,000/mm 3 or a progressive decline in either is an indication to withhold further therapy until blood counts have recovered above these levels.
Patients should be advised of the potential toxicity of this drug, particularly bone marrow suppression.
Like all medications, Mitomycin can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: