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

NDC 0143-9260-01

Rx only

Mesna Injection

1 g/10 mL

(100 mg/mL)

FOR INTRAVENOUS USE

10 mL Mutliple-Dose Vial carton

MESNA
mesna injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:62778-304
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MESNA (UNII: NR7O1405Q9) (2-MERCAPTOETHANESULFONIC ACID - UNII:VHD28S0H7F)	MESNA	100 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62778-304-01	1 in 1 CARTON	02/23/2004	02/23/2004
1		10 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA075739	02/23/2004	02/23/2004

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

Hikma Farmaceutica