Mitomycin Side Effects

Brand Names: Mutamycin

Please note - some side effects for Mitomycin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Mitomycin - for the Consumer

Mitomycin

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Mitomycin:

Hair loss; loss of appetite; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; decreased urination; dizziness; dry cough; fever, chills, or sore throat; pain, redness, or swelling at the injection site; shortness of breath; sores or swelling of the mouth, lips, hands, or feet; unusual bruising or bleeding; unusual tiredness or weakness.

Side Effects by Body System

Hematologic

Recovery from thrombocytopenia has generally been reported to take place within ten weeks. Approximately 25% of leukopenic or thrombocytopenic episodes have been reported to have not recovered.

Hematologic side effects including bone marrow toxicity (64.4%) have been the most common and most serious toxicity associated with the use of mitomycin. Thrombocytopenia and/or leukopenia have been reported to occur anytime within eight weeks of initiation of therapy. Mitomycin produces cumulative myelosuppression.

Other

Other side effects have included hemolytic uremic syndrome (HUS).

HUS has been reported to occur most often at doses greater than or equal to 60 mg. HUS consists primarily of microangiopathic hemolytic anemia (hematocrit less than or equal to 25%), thrombocytopenia (platelet count less than or equal to 100,000/mm3), and irreversible renal failure (serum creatinine greater than or equal to 1.6 mg/dL). A 52% mortality rate has been associated with this syndrome.

Dermatologic

Dermatologic side effects have included the necrosis and consequent sloughing of tissue which results if the drug is extravasated during injection. Alopecia has been frequently reported. Cellulitis at the injection site has been reported and is occasionally severe. Rashes have rarely been reported. Delayed erythema and/or ulceration has been reported to occur either at or distant from the injection site, weeks to months after mitomycin. Allergic contact dermatitis has also been reported.

Extravasation has been reported even without an accompanying stinging or burning sensation and even if their is adequate blood return when the injection needle is aspirated.

Respiratory

Respiratory side effects have been reported infrequently. However, they may be severe and even life threatening. Adult respiratory distress syndrome has been reported.

Dyspnea with a nonproductive cough and radiographic evidence of pulmonary infiltrates may be indicative of mitomycin-induced pulmonary toxicity.

Adult respiratory distress syndrome has been reported in a few patients receiving mitomycin in combination with other chemotherapy and maintained at fraction of inspired oxygen concentrations greater than 50% perioperatively. Because oxygen itself is toxic to the lungs, it is recommended to use only enough oxygen to provide adequate arterial saturation.

Renal

No correlation between the total dose administered or duration of therapy and the degree of renal impairment has been reported.

Renal side effects including a statistically significant rise in creatinine (2%) have been reported.

Cardiovascular

Cardiovascular side effects including congestive heart failure have rarely been reported. Edema and thrombophlebitis have also been reported.

Almost all of the patients who experience congestive heart failure had received prior doxorubicin therapy.

General

General side effects including fever, headache, confusion, drowsiness, syncope, fatigue, and pain have been reported.

Gastrointestinal

Gastrointestinal side effects including anorexia, nausea, vomiting and diarrhea have been reported.

Genitourinary

Genitourinary side effects including two cases of urethral slough and one case of necrosis of the glans penis have been reported.

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