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warnings and cautions
5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions: Anaphylactic reactions have been reported. Less severe hypersensitivity reactions may also occur. Monitor patients. If a reaction occurs, discontinue mesna and provide supportive care. ( 5.1 ) Dermatologic toxicity: Skin rash with eosinophilia and systemic symptoms, Stevens-Johnson syndrome, and toxic epidermal necrolysis have occurred. Skin rash, urticaria, and angioedema have also been seen. Monitor patients. If a reaction occurs, discontinue mesna and provide supportive care. ( 5.2 ) Benzyl alcohol toxicity: Serious and fatal adverse reactions can occur in premature neonates and low-birth weight infants treated with benzyl alcohol-preserved drugs, including MESNEX injection. Avoid use in premature neonates and low-birth weight infants. ( 5.3 ) Laboratory test alterations: False positive tests for urinary ketones and interference with enzymatic CPK activity tests have been seen. ( 5.4 ) 5.1 Hypersensitivity Reactions Mesna may cause systemic hypersensitivity reactions, including anaphylaxis. These reactions may include fever, cardiovascular symptoms (hypotension, tachycardia), acute renal impairment, hypoxia, respiratory distress, urticaria, angioedema, laboratory signs of disseminated intravascular coagulation, hematological abnormalities, increased liver enzymes, nausea, vomiting, arthralgia, and myalgia. These reactions may occur with the first exposure or after several months of exposure. Monitor for signs or symptoms. Discontinue mesna and provide supportive care. 5.2 Dermatologic Toxicity Drug rash with eosinophilia and systemic symptoms and bullous and ulcerative skin and mucosal reactions, consistent with Stevens-Johnson syndrome or toxic epidermal necrolysis have occurred. Mesna may cause skin and mucosal reactions characterized 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 Toxicity Serious adverse reactions including fatal reactions and the “gasping syndrome” occurred in premature neonates and low-birth weight infants who received benzyl alcohol dosages of 99 to 234 mg/kg/day (blood levels of benzyl alcohol were 0.61 to 1.378 mmol/L). Symptoms associated with “gasping syn...
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adverse reactions
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) ] 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 Ingenus Pharmaceuticals, LLC at 1-877-748-1970 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 oral doses of 600-2400 mg of mesna tablets were administered to a total of 82 healthy volunteers. In two Phase 1 multiple-dose studies where healthy volunteers received mesna tablets alone or intravenous MESNEX followed by repeated doses of mesna tablets, flatulence and rhinitis were reported. Additional adverse reactions in healthy volunteers receiving mesna alone included 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. Advers...
adverse reactions table
Table 3: Adverse Reactions in ≥5% of Patients Receiving Mesna in combination with Ifosfamide-containing Regimens Mesna RegimenIntravenous-Oral-OralIntravenous dosing of ifosfamide and MESNEX followed by oral doses of mesna according to the applicable dosage schedule [see Dosage and Administration (2)].N exposed119 (100%)Incidence of AEs106 (89.1%)Nausea64 (53.8)Vomiting45 (37.8)Constipation21 (17.6)Leukopenia21 (17.6)Fatigue24 (20.2)Fever18 (15.1)Anorexia19 (16.0)Thrombocytopenia16 (13.4)Anemia21 (17.6)Granulocytopenia15 (12.6)Asthenia21 (17.6)Abdominal Pain18 (15.1)Alopecia13 (10.9)Dyspnea11 (9.2)Chest Pain11 (9.2)Hypokalemia11 (9.2)Diarrhea17 (14.3)Dizziness5 (4.2)Headache13 (10.9)Pain10 (8.4)Sweating Increased2 (1.7)Back Pain6 (5.0)Hematuria7 (5.9)Injection Site Reaction10 (8.4)Edema9 (7.6)Edema Peripheral8 (6.7)Somnolence12 (10.1)Anxiety4 (3.4)Confusion6 (5.0)Face Edema5 (4.2)Insomnia11 (9.2)Coughing10 (8.4)Dyspepsia6 (5.0)Hypotension6 (5.0)Pallor6 (5.0)Dehydration7 (5.9)Pneumonia8 (6.7)Tachycardia7 (5.9)Flushing6 (5.0)