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FDA Drug information

Mesna

Read time: 1 mins
Marketing start date: 23 Nov 2024
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Summary of product characteristics


Adverse Reactions

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 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"

Effective Time

20230519

Version

3

Spl Product Data Elements

mesna mesna MESNA 2-MERCAPTOETHANESULFONIC ACID EDETATE DISODIUM BENZYL ALCOHOL SODIUM HYDROXIDE HYDROCHLORIC ACID

Application Number

ANDA075739

Brand Name

Mesna

Generic Name

mesna

Product Ndc

62778-304

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAVENOUS

Package Label Principal Display Panel

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 NDC 0143-9260-01 Rx only Mesna Injection 1 g/10 mL (100 mg/mL) FOR INTRAVENOUS USE 10 mL Mutliple-Dose Vial carton unit label carton

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