Mitomycin Injection USP 2 & 10 mg

Mitomycin is contraindicated for intravesical administration in patients who have demonstrated a hypersensitive or idiosyncratic reaction to it in the past.

Acute Side Effects: Fever, hemolytic anemia, anorexia, stomatitis, hypoglycemia, mucositis and diarrhea have occurred.

Other Undesirable Side Effects: headache, blurring of vision, confusion, drowsiness, syncope, fatigue, weakness, edema, thrombophlebitis, hematemesis, nausea, vomiting, weight loss, ataxia and pain. It is difficult to determine whether these side effects are dose-related or due to the primary or metastatic disease process.

Genitourinary Irritation: Genitourinary irritation following intravesical administration indicated dysuria, cystitis, nocturia and increased frequency of micturition, hematuria, and other symptoms of local irritation. Approximately 25% of the patients treated experienced irritative symptoms, but not all were unequivocally drug-related and may have been symptoms of the disease.

Dermatitis: Dermatitis occurred in approximately 10% of the patients treated. It was commonly manifested as palmar rash with desquamation, generally appearing on the extremities and less often on the trunk, and also as genital rash. Topical steroids have been employed but their therapeutic value has not been determined.