Bone Marrow Suppression; Hemolytic Uremic Syndrome
Experienced Physician/Equipped Facility
- Mitomycin for injection 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
- 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 MUTAMYCIN (see Warnings and Adverse Reactions).
Hemolytic Uremic Syndrome
- 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.
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- Hemolytic uremic syndrome consists of microangiopathic hemolytic anemia, thrombocytopenia, and irreversible renal failure.
- Perform platelet count, WBC, differential and hemoglobin during and for at least eight weeks after therapy.
- Interrupt therapy if platelet count < 100>
Patient Counseling Information