Label: MESNA injection, solution
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- NDC Code(s): 62778-304-01
- Packager: Hikma Farmaceutica
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 19, 2023
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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.
Initial U.S. Approval:1988
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 Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-332-1088 or www.fda.gov/medwatch.
"1-800-FDA-1088"
Revised: 5/2023
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Table of Contents
FULL PRESCRIBING INFORMATION: CONTENTS*
ADVERSE REACTIONS
- *
- Sections or subsections omitted from the full prescribing information are not listed.
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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)]
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MESNA
mesna injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62778-304 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MESNA (UNII: NR7O1405Q9) (2-MERCAPTOETHANESULFONIC ACID - UNII:VHD28S0H7F) MESNA 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) 0.25 mg in 1 mL BENZYL ALCOHOL (UNII: LKG8494WBH) 10.4 mg in 1 mL SODIUM HYDROXIDE (UNII: 55X04QC32I) HYDROCHLORIC ACID (UNII: QTT17582CB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62778-304-01 1 in 1 CARTON 02/23/2004 1 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075739 02/23/2004 Labeler - Hikma Farmaceutica (452742943) Registrant - Hikma Pharmaceuticals USA Inc. (001230762)
