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

mesna by

Drug Labeling and Warnings

mesna by is a Prescription medication manufactured, distributed, or labeled by Hikma Farmaceutica, Hikma Pharmaceuticals USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MESNA- mesna injection, solution 
Hikma Farmaceutica

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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: 2/2024

FULL PRESCRIBING INFORMATION: CONTENTS*

ADVERSE REACTIONS

  • * Sections or subsections omitted from the full prescribing information are not listed.
    		•

    FULL PRESCRIBING INFORMATION

    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

    NDC: 0143-9260-01

    Rx only

    Mesna Injection

    1 g/10 mL

    (100 mg/mL)

    FOR INTRAVENOUS USE

    10 mL Mutliple-Dose Vial

    unit label

    NDC: 0143-9260-01

    Rx only

    Mesna Injection

    1 g/10 mL

    (100 mg/mL)

    FOR INTRAVENOUS USE

    10 mL Mutliple-Dose Vial carton

    carton
    MESNA 
    mesna injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 62778-304
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MESNA (UNII: NR7O1405Q9) (2-MERCAPTOETHANESULFONIC ACID - UNII:VHD28S0H7F) MESNA100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 62778-304-011 in 1 CARTON02/23/200402/23/2004
    110 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07573902/23/200402/23/2004
    Labeler - Hikma Farmaceutica (452742943)
    Registrant - Hikma Pharmaceuticals USA Inc. (001230762)

    Revised: 2/2024
    Document Id: 2d60015b-0e21-471d-8a31-20704dd8ae93
    Set id: 6d5b28d0-8e5a-4c62-a3e9-03c78524e6c8
    Version: 5
    Effective Time: 20240209
     
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