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warnings
WARNINGS Allergic reactions to mesna ranging from mild hypersensitivity to systemic anaphylactic reactions have been reported. Patients with autoimmune disorders who were treated with cyclophosphamide and mesna appeared to have a higher incidence of allergic reactions. The majority of these patients received mesna orally. Mesna has been developed as an agent to reduce the risk of ifosfamide-induced hemorrhagic cystitis. It will not prevent or alleviate any of the other adverse reactions or toxicities associated with ifosfamide therapy. Mesna does not prevent hemorrhagic cystitis in all patients. Up to 6% of patients treated with mesna have developed hematuria (>50 RBC/hpf or WHO grade 2 and above). As a result, a morning specimen of urine should be examined for the presence of hematuria (microscopic evidence of red blood cells) each day prior to ifosfamide therapy. If hematuria develops when mesna is given with ifosfamide according to the recommended dosage schedule, depending on the severity of the hematuria, dosage reductions or discontinuation of ifosfamide therapy may be initiated. In order to reduce the risk of hematuria, mesna must be administered with each dose of ifosfamide as outlined in the DOSAGE AND ADMINISTRATION section. Mesna is not effective in reducing the risk of hematuria due to other pathological conditions such as thrombocytopenia. Because of the benzyl alcohol content, the multidose vial should not be used in neonates or infants and should be used with caution in older pediatric patients.
ADVERSE REACTIONS Mesna adverse reaction data are available from four phase I studies in which single IV bolus doses of 600 to 1200 mg mesna injection without concurrent chemotherapy were administered to a total of 53 subjects. The most frequently reported side effects (observed in two or more patients) for patients receiving single doses of mesna injection were headache, injection site reactions, flushing, dizziness, nausea, vomiting, somnolence, diarrhea, anorexia, fever, pharyngitis, hyperaesthesia, influenza-like symptoms, and coughing. In addition, constipation was reported by patients who had received repeated doses of mesna injection. Because mesna is used in combination with ifosfamide or ifosfamide-containing chemotherapy regimens, it is difficult to distinguish the adverse reactions which may be due to mesna from those caused by the concomitantly administered cytotoxic agents. Adverse reactions reasonably associated with mesna administered IV in four controlled studies in which patients received ifosfamide or ifosfamide-containing regimens are presented in Table 2. Table 2 Incidence of Adverse Events and Incidence of Most Frequently Reported Adverse Events in Controlled Studies Mesna Regimen IV-IV-IV N exposed 119 (100.0%) Incidence of AEs 101 (84.9%) Most Frequently Reported Adverse Events (Preferred Terms) N (%) Nausea 65 (54.6) Vomiting 35 (29.4) Constipation 28 (23.5) Leukopenia 25 (21.0) Fatigue 24 (20.2) Fever 24 (20.2) Anorexia 21 (17.6) Thrombocytopenia 21 (17.6) Anemia 20 (16.8) Granulocytopenia 16 (13.4) Asthenia 15 (12.6) Abdominal Pain 14 (11.8) Alopecia 12 (10.1) Dyspnea 11 (9.2) Chest Pain 10 (8.4) Hypokalemia 10 (8.4) Diarrhea 9 (7.6) Dizziness 9 (7.6) Headache 9 (7.6) Pain 9 (7.6) Sweating Increased 9 (7.6) Back Pain 8 (6.7) Hematuria All grades 8 (6.7) Injection Site Reaction 8 (6.7) Edema 8 (6.7) Edema Peripheral 8 (6.7) Somnolence 8 (6.7) Anxiety 7 (5.9) Confusion 7 (5.9) Face Edema 6 (5.0) Insomnia 6 (5.0) Coughing 5 (4.2) Dyspepsia 4 (3.4) Hypotension 4 (3.4) Pallor 4 (3.4) Dehydration 3 (2.5) Pneumonia 2 (1.7) Tachycardia 1 (0.8) Flushing 1 (0.8) Postmarketing Surveillance Allergic reactions, decreased platelet counts associated with allergic reactions, hypertension, hypotension, increased heart rate, increased liver enzymes, injection site reactions (including pain and erythema), limb pain, malaise, myalgia, ST-segment elevation, tachycardia, and tachypnea have been reported as part of postmarketing surveillance.