ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. The following are discussed in more detail in other sections of the labeling.o Hypersensitivity Reactions [see Warnings and Precautions (5.1)] Dermatological Toxicity [see Warnings and Precautions (5.2)] Benzyl Alcohol Toxicity[see Warnings and Precautions (5.3)] Laboratory Test Interferences [see Warnings and Precautions (5.4)] Use in Patients with History of Adverse Reactions to Thiol Compounds [see Warnings and Precautions (5.5)] The most common adverse reactions (> 10%) when mesna is given with ifosfamide are nausea, vomiting, constipation, leukopenia, fatigue, fever, anorexia, thrombocytopenia, anemia, granulocytopenia, diarrhea, asthenia, abdominal pain, headache, alopecia, and somnolence. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-332-1088 or www.fda.gov/medwatch.1-800-FDA-1088.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL. NDC 0143-9260-01Rx onlyMesna Injection1 g/10 mL(100 mg/mL)FOR INTRAVENOUS USE10 mL Mutliple-Dose VialNDC 0143-9260-01Rx onlyMesna Injection1 g/10 mL(100 mg/mL)FOR INTRAVENOUS USE10 mL Mutliple-Dose Vial carton. unit label. carton.