Mutamycin Side Effects

Generic Name: mitomycin

Please note - some side effects for Mutamycin 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 Mutamycin - for the Consumer

Mutamycin

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 Mutamycin:

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.

Mutamycin Side Effects - for the Professional

Mutamycin

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. Mutamycin produces cumulative myelosuppression.

Integument and Mucous Membrane Toxicity

This has occurred in approximately 4% of patients treated with Mutamycin. 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. Extravasation may occur with or without an accompanying stinging or burning sensation and even if there is adequate blood return when the injection needle is aspirated. There have been reports of delayed erythema and/or ulceration occurring either at or distant from the injection site, weeks to months after Mutamycin, even when no obvious evidence of extravasation was observed during administration. Skin grafting has been required in some of the cases.

Renal Toxicity

2% of 1,281 patients demonstrated a statistically significant rise in creatinine. There appeared to be no correlation between total dose administered or duration of therapy and the degree of renal impairment.

Pulmonary Toxicity

This has occurred infrequently but can be severe and may be life threatening. Dyspnea with a nonproductive cough and radiographic evidence of pulmonary infiltrates may be indicative of Mutamycin-induced pulmonary toxicity. If other etiologies are eliminated, Mutamycin therapy should be discontinued. Steroids have been employed as treatment of this toxicity, but the therapeutic value has not been determined. A few cases of adult respiratory distress syndrome have been reported in patients receiving Mutamycin in combination with other chemotherapy and maintained at FIO2 concentrations greater than 50% perioperatively.

Hemolytic Uremic Syndrome (HUS)

This serious complication of chemotherapy, consisting primarily of microangiopathic hemolytic anemia (hematocrit ≤25%), thrombocytopenia (≤100,000/mm3), and irreversible renal failure (serum creatinine ≥1.6 mg/dL) has been reported in patients receiving systemic Mutamycin. Microangiopathic hemolysis with fragmented red blood cells on peripheral blood smears has occurred in 98% of patients with the syndrome. Other less frequent complications of the syndrome may include pulmonary edema (65%), neurologic abnormalities (16%), and hypertension. Exacerbation of the symptoms associated with HUS has been reported in some patients receiving blood product transfusions. A high mortality rate (52%) has been associated with this syndrome.

The syndrome may occur at any time during systemic therapy with Mutamycin (mitomycin for injection, USP) as a single agent or in combination with other cytotoxic drugs. Less frequently, HUS has also been reported in patients receiving combinations of cytotoxic drugs not including Mutamycin. Of 83 patients studied, 72 developed the syndrome at total doses exceeding 60 mg of Mutamycin. Consequently, patients receiving ≥60 mg of Mutamycin should be monitored closely for unexplained anemia with fragmented cells on peripheral blood smear, thrombocytopenia, and decreased renal function.

The incidence of the syndrome has not been defined.

Therapy for the syndrome is investigational.

Cardiac Toxicity

Congestive heart failure, often treated effectively with diuretics and cardiac glycosides, has rarely been reported. Almost all patients who experienced this side effect had received prior doxorubicin therapy.

Acute Side Effects Due to Mutamycin were fever, anorexia, nausea, and vomiting. They occurred in about 14% of 1,281 patients.

Other

Headache, blurring of vision, confusion, drowsiness, syncope, fatigue, edema, thrombophlebitis, hematemesis, diarrhea, and pain. These did not appear to be dose related and were not unequivocally drug related. They may have been due to the primary or metastatic disease processes. Malaise and asthenia have been reported as part of postmarketing surveillance. Bladder fibrosis/contraction has been reported with intravesical administration.

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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