HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Mesna Injection safely and effectively. See full prescribing information for Mesna Injection.
Mesna Injection for Intravenous Use
Initial U.S. Approval: 1988
INDICATIONS AND USAGE
Mesna is a cytoprotective agent indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. (1)
Limitation of Use: Mesna is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia. (1)
DOSAGE AND ADMINISTRATION
Mesna may be given on a fractionated dosing schedule of three bolus intravenous injections or a single bolus injection followed by two oral administrations of mesna Tablets as outlined below. The dosing schedule should be repeated on each day that ifosfamide is administered. When the dosage of ifosfamide is adjusted, the ratio of mesna to ifosfamide should be maintained. (2)
Intravenous Dosing Schedule 
 0 Hours
 4 Hours
 8 Hours
Ifosfamide
 1.2 g/m2
Mesna Injection
 240 mg/m2
 240 mg/m2
 240 mg/m2
Intravenous and Oral Dosing Schedule 
 0 Hours
 4 Hours
 6 Hours
Ifosfamide
 1.2 g/m2
 -
 -
Mesna Injection
 240 mg/m2
 -
 -
Mesna Tablets
 480 mg/m2
 480 mg/m2
Maintain sufficient urinary output, as required for ifosfamide treatment, and monitor urine for the presence of hematuria. (2.3)
DOSAGE FORMS AND STRENGTHS
  Injection: 1g (100 mg/mL) Multidose vials (3)
CONTRAINDICATIONS
Known hypersensitivity to mesna or to any of the excipients, including benzyl alcohol. (4)
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: The preservative benzyl alcohol has been associated with serious adverse reactions and death in neonates and premature infants. Avoid use in neonates, premature, 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)
ADVERSE REACTIONS
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 Mylan Pharmaceuticals Inc. at 1 877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
USE IN SPECIFIC POPULATIONS
  Pregnancy: Use only if clearly needed. (8.1)
  Nursing mothers: Women should not breastfeed during therapy. (8.3)
  Geriatric use: Dose selection should be cautious. (8.5)
See 17 for P