ATIENT COUNSELING INFORMATION.
Revised: 7/2014
FULL PRESCRIBING INFORMATION: CONTENTS*
1. INDICATIONS AND USAGE
2. DOSAGE AND ADMINISTRATION
2.1 Intravenous Dosing 2.2 Intravenous and Oral Dosing 2.3 Monitoring for Hematuria 2.4 Preparation for Intravenous Administration and Stability 3. DOSAGE FORMS AND STRENGTHS
4. CONTRAINDICATIONS
5. WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions 5.2 Dermatologic Toxicity 5.3 Benzyl Alcohol Toxicity 5.4 Laboratory Test Interferences 5.5 Use in Patients with a History of Adverse Reactions to Thiol Compounds 6. ADVERSE REACTIONS
6.1 Clinical Trials Experience 6.2 Postmarketing Experience 7. DRUG INTERACTIONS
8. USE IN SPECIFIC POPULATIONS
8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Use in Patients with Renal Impairment 8.7 Use in Patients with Hepatic Impairment 10. OVERDOSAGE
11. DESCRIPTION
12. CLINICAL PHARMACOLOGY
12.1 Mechanism of Action 12.3 Pharmacokinetics 13. NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14. CLINICAL STUDIES
14.1 Intravenous Mesna 16. HOW SUPPLIED/STORAGE AND HANDLING
17. PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed. Close
1. INDICATIONS AND USAGE
Mesna is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis.
Limitation of Use:
Mesna is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia.
2. DOSAGE AND ADMINISTRATION
2.1 Intravenous DosingMesna may be given on a fractionated dosing schedule of three bolus intravenous injections as outlined below.
Mesna injection is given as intravenous bolus injections in a dosage equal to 20% of the ifosfamide dosage weight by weight (w/w) at the time of ifosfamide administration and 4 and 8 hours after each dose of ifosfamide. The total daily dose of mesna is 60% of the ifosfamide dose. The recommended dosing schedule is outlined below in Table 1.
Table1. Recommended Intravenous Dosing Schedule 1The dosing schedule should be repeated on each day that ifosfamide is administered. When the dosage of ifosfamide is increased or decreased, the ratio of mesna to ifosfamide should be maintained.
0 Hours
4 Hours
8 Hours
Ifosfamide
1.2 g/m2
–
–
Mesna injection1
240 mg/m2
240 mg/m2
240 mg/m2
2.2 Intravenous and Oral DosingMesna may be given on a fractionated dosing schedule of a single bolus injection followed by two oral administrations of mesna tablets as outlined below.
Mesna injection is given as intravenous bolus injections in a dosage equal to 20% of the ifosfamide dosage (w/w) at the time of ifosfamide administration. Mesna tablets are given orally in a dosage equal to 40% of the ifosfamide dose 2 and 6 hours after each dose of ifosfamide. The total daily dose of mesna is 100% of the ifosfamide dose. The recommended dosing schedule is outlined in Table 2.
Table 2. Recommended Intravenous and Oral Dosing Schedule 1The dosing schedule should be repeated on each day that ifosfamide is administered. When the dosage of ifosfamide is increased or decreased, the ratio of mesna to ifosfamide should be maintained.
0 Hours
2 Hours
6 Hours
Ifosfamide
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