Mesna (Page 2 of 4)

5.4 Laboratory Test Interferences


False-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 reactivation. 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 Compounds

Mesna 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 Injection.

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 Experience

Because 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 to 1,200 mg mesna injection without concurrent chemotherapy were administered to a total of 53 healthy volunteers and single oral doses of 600 to 2,400 mg of mesna tablets were administered to a total of 82 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 site reactions, flushing, dizziness, nausea, vomiting, somnolence, diarrhea, anorexia, fever, pharyngitis, hyperesthesia, influenza-like symptoms, and coughing. In two Phase 1 multiple-dose studies where healthy volunteers received mesna tablets alone or intravenous mesna injection followed by repeated doses of mesna tablets, flatulence and rhinitis were reported. In addition, constipation was reported by healthy volunteers who had received repeated doses of intravenous mesna injection.
Additional adverse reactions in healthy volunteers receiving mesna alone included injection site reactions, abdominal pain/colic, epigastric pain/burning, mucosal irritation, lightheadedness, back pain, arthralgia, myalgia, conjunctivitis, nasal congestion, rigors, paresthesia, photophobia, fatigue, lymphadenopathy, extremity pain, malaise, chest pain, dysuria, pleuritic pain, dry mouth, dyspnea, and hyperhidrosis. In healthy volunteers, mesna was commonly associated with a rapid (within 24 hours) decrease in lymphocyte count, which was generally reversible within one week of administration.
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 intravenously and orally in four controlled studies in which patients received ifosfamide or ifosfamide-containing regimens are presented in Table 3.Table 3. Adverse Reactions in ≥5% of Patients Receiving Mesna in combination with Ifosfamide-containing Regimens

Mesna Regimen Intravenous-Intravenous-Intravenous1 Intravenous-Oral-Oral1
N exposed 119 (100%) 119 (100%)
Incidence of AEs 101 (84.9%) 106 (89.1%)
Nausea 65 (54.6) 64 (53.8)
Vomiting 35 (29.4) 45 (37.8)
Constipation 28 (23.5) 21 (17.6)
Leukopenia 25 (21.0) 21 (17.6)
Fatigue 24 (20.2) 24 (20.2)
Fever 24 (20.2) 18 (15.1)
Anorexia 21 (17.6) 19 (16.0)
Thrombocytopenia 21 (17.6) 16 (13.4)
Anemia 20 (16.8) 21 (17.6)
Granulocytopenia 16 (13.4) 15 (12.6)
Asthenia 15 (12.6) 21 (17.6)
Abdominal Pain 14 (11.8) 18 (15.1)
Alopecia 12 (10.1) 13 (10.9)
Dyspnea 11 (9.2) 11 (9.2)
Chest Pain 10 (8.4) 11 (9.2)
Hypokalemia 10 (8.4) 11 (9.2)
Diarrhea 9 (7.6) 17 (14.3)
Dizziness 9 (7.6) 5 (4.2)
Headache 9 (7.6) 13 (10.9)
Pain 9 (7.6) 10 (8.4)
Sweating Increased 9 (7.6) 2 (1.7)
Back Pain 8 (6.7) 6 (5.0)
Hematuria 8 (6.7) 7 (5.9)
Injection Site Reaction 8 (6.7) 10 (8.4)
Edema 8 (6.7) 9 (7.6)
Edema Peripheral 8 (6.7) 8 (6.7)
Somnolence 8 (6.7) 12 (10.1)
Anxiety 7 (5.9) 4 (3.4)
Confusion 7 (5.9) 6 (5.0)
Face Edema 6 (5.0) 5 (4.2)
Insomnia 6 (5.0) 11 (9.2)
Coughing 5 (4.2) 10 (8.4)
Dyspepsia 4 (3.4) 6 (5.0)
Hypotension 4 (3.4) 6 (5.0)
Pallor 4 (3.4) 6 (5.0)
Dehydration 3 (2.5) 7 (5.9)
Pneumonia 2 (1.7) 8 (6.7)
Tachycardia 1 (0.8) 7 (5.9)
Flushing 1 (0.8) 6 (5.0)

1 Intravenous dosing of ifosfamide and mesna injection followed by either intravenous or oral doses of mesna according to the applicable dosage schedule [see Dosage and Administration (2)].

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