erized by urticaria, rash, erythema, pruritus, burning sensation, angioedema, periorbital edema, flushing and stomatitis. These reactions may occur with the first exposure or after several months of exposure. Discontinue mesna and provide supportive care.
5.3 Benzyl Alcohol ToxicityBenzyl alcohol, a preservative in mesna injection, has been associated with serious adverse reactions and death (including gasping syndrome) in neonates and premature infants. The minimum amount of benzyl alcohol at which toxicity may occur is not known. Consider the combined daily metabolic load of benzyl alcohol from all sources when prescribing mesna (10.4 mg benzyl alcohol per mL). Preterm and low-birth weight infants, as well as patients receiving high dosages, may be more likely to develop toxicity. Monitor patients for signs or symptoms of toxicity. Avoid use in neonates and premature infants. The safety and effectiveness of mesna have not been established in pediatric patients [See Use in Specific Populations (8.4)].
5.4 Laboratory Test InterferencesFalse-Positive Urine Tests for Ketone Bodies
A false positive test for urinary ketones may arise in patients treated with mesna when using nitroprusside sodium-based urine tests (including dipstick tests). The addition of glacial acetic acid can be used to differentiate between a false positive result (cherry-red color that fades) and a true positive result (red-violet color that intensifies).
False-Negative Tests for Enzymatic CPK Activity
Mesna may interfere with enzymatic creatinine phosphokinase (CPK) activity tests that use a thiol compound (e.g., N-acetylcysteine) for CPK reactiviation. This may result in a falsely low CPK level.
False-Positive Tests for Ascorbic Acid
Mesna may cause false-positive reactions in Tillman's reagent-based urine screening tests for ascorbic acid.
5.5 Use in Patients with a History of Adverse Reactions to Thiol CompoundsMesna is a thiol compound, i.e., a sulfhydryl (SH) group-containing organic compound. Hypersensitivity reactions to mesna and to amifostine, another thiol compound, have been reported. It is not clear whether patients who experienced an adverse reaction to a thiol compound are at increased risk for a hypersensitivity reaction to mesna.
6. ADVERSE REACTIONS
The following are discussed in more detail in other sections of the labeling.
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 a History of Adverse Reactions to Thiol Compounds [See Warnings and Precautions (5.5)]
6.1 Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Mesna adverse reaction data are available from four Phase 1 studies in which single intravenous doses of 600 to1200 mg mesna injection without concurrent chemotherapy were administered to a total of 53 healthy volunteers. The most frequently reported side effects (observed in two or more healthy volunteers) for healthy volunteers receiving single doses of mesna injection alone were headache, injection s |
