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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 MESNEX 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 MESNEX 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 MESNEX 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 MESNEX 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. MESNEX 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 MESNEX 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 wit...
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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 MESNEX 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 Baxter Healthcare at 1-866-888-2472, 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. MESNEX adverse reaction data are available from four Phase 1 studies in which single intravenous doses of 600-1200 mg MESNEX injection without concurrent chemotherapy were administered to a total of 53 healthy volunteers and single oral doses of 600-2400 mg of MESNEX 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 MESNEX 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 MESNEX tablets alone or intravenous MESNEX followed by repeated doses of MESNEX tablets, flatulence and rhinitis were reported. In addition, constipation was reported by healthy volunteers who had received repeated doses of intravenous MESNEX. Additional adverse reactions in healthy volunteers receiving MESNEX alone included injection site reactions, abdominal pain/colic, epigastric pain/burning, mucosal irritation, lightheadedness, back pain, arthralgia, myalgia, ...
adverse reactions table
Table 3: Adverse Reactions in ≥5% of Patients Receiving MESNEX in combination with Ifosfamide-containing Regimens MESNEX RegimenIntravenous-Intravenous-IntravenousIntravenous dosing of ifosfamide and MESNEX followed by either intravenous or oral doses of MESNEX according to the applicable dosage schedule [see Dosage and Administration (2)].Intravenous-Oral-OralN exposed119 (100.0%)119 (100%)Incidence of AEs101 (84.9%)106 (89.1%)Nausea65 (54.6)64 (53.8)Vomiting35 (29.4)45 (37.8)Constipation28 (23.5)21 (17.6)Leukopenia25 (21.0)21 (17.6)Fatigue24 (20.2)24 (20.2)Fever24 (20.2)18 (15.1)Anorexia21 (17.6)19 (16.0)Thrombocytopenia21 (17.6)16 (13.4)Anemia20 (16.8)21 (17.6)Granulocytopenia16 (13.4)15 (12.6)Asthenia15 (12.6)21 (17.6)Abdominal Pain14 (11.8)18 (15.1)Alopecia 12 (10.1)13 (10.9)Dyspnea11 (9.2)11 (9.2)Chest Pain10 (8.4)11 (9.2)Hypokalemia10 (8.4)11 (9.2)Diarrhea9 (7.6)17 (14.3)Dizziness9 (7.6)5 (4.2)Headache9 (7.6)13 (10.9)Pain9 (7.6)10 (8.4)Sweating Increased9 (7.6)2 (1.7)Back Pain8 (6.7)6 (5.0)Hematuria8 (6.7)7 (5.9)Injection Site Reaction8 (6.7)10 (8.4)Edema8 (6.7)9 (7.6)Edema Peripheral8 (6.7)8 (6.7)Somnolence8 (6.7)12 (10.1)Anxiety7 (5.9)4 (3.4)Confusion7 (5.9)6 (5.0)Face Edema6 (5.0)5 (4.2)Insomnia6 (5.0)11 (9.2)Coughing5 (4.2)10 (8.4)Dyspepsia4 (3.4)6 (5.0)Hypotension4 (3.4)6 (5.0)Pallor4 (3.4)6 (5.0)Dehydration3 (2.5)7 (5.9)