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Mesnex

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Mesnex

Indications
Dosage
How Supplied

INDICATIONS

MESNEX is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis.

Limitation of Use

MESNEX is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia.

DOSAGE AND ADMINISTRATION

Intravenous Dosing

MESNEX may be given on a fractionated dosing schedule of three bolus intravenous injections as outlined below.

MESNEX 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 MESNEX is 60% of the ifosfamide dose. The recommended dosing schedule is outlined below in Table 1.

Table 1: Recommended Intravenous Dosing Schedule

  0 Hours 4 Hours 8 Hours
Ifosfamide 1.2 g/m² - -
MESNEX Injection1 240 mg/m² 240 mg/m² 240 mg/m²
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 MESNEX to ifosfamide should be maintained.

Intravenous And Oral Dosing

MESNEX may be given on a fractionated dosing schedule of a single bolus injection followed by two oral administrations of MESNEX tablets as outlined below.

MESNEX 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. MESNEX 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 MESNEX is 100% of the ifosfamide dose. The recommended dosing schedule is outlined in Table 2.

Table 2: Recommended Intravenous and Oral Dosing Schedule

  0 Hours 2 Hours 6 Hours
Ifosfamide 1.2 g/m² - -
MESNEX injection1 240 mg/m² - -
MESNEX tablets - 480 mg/m² 480 mg/m²
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 MESNEX to ifosfamide should be maintained.

The efficacy and safety of this ratio of intravenous and oral MESNEX has not been established as being effective for daily doses of ifosfamide higher than 2 g/m².

Patients who vomit within two hours of taking oral MESNEX should repeat the dose or receive intravenous MESNEX.

Monitoring For Hematuria

Maintain adequate hydration and sufficient urinary output, as required for ifosfamide treatment, and monitor urine for the presence of hematuria. If severe hematuria develops when MESNEX is given according to the recommended dosage schedule, dosage reductions or discontinuation of ifosfamide therapy may be required.

Preparation For Intravenous Administration And Stability

Preparation

Determine the volume of MESNEX injection for the intended dose.

Dilute the volume of MESNEX injection for the dose in any of the following fluids to obtain a final concentration of 20 mg/mL:

  • 5% Dextrose Injection, USP
  • 5% Dextrose and 0.2% Sodium Chloride Injection, USP
  • 5% Dextrose and 0.33% Sodium Chloride Injection, USP
  • 5% Dextrose and 0.45% Sodium Chloride Injection, USP
  • 0.9% Sodium Chloride Injection, USP
  • Lactated Ringer's Injection, USP
Stability

The MESNEX injection multidose vials may be stored and used for up to 8 days after initial puncture.

Store diluted solutions at 25°C (77°F). Use diluted solutions within 24 hours.

Do not mix MESNEX injection with epirubicin, cyclophosphamide, cisplatin, carboplatin, and nitrogen mustard.

The benzyl alcohol contained in MESNEX injection vials can reduce the stability of ifosfamide. Ifosfamide and MESNEX may be mixed in the same bag provided the final concentration of ifosfamide does not exceed 50 mg/mL. Higher concentrations of ifosfamide may not be compatible with MESNEX and may reduce the stability of ifosfamide.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Any solutions which are discolored, hazy, or contain visible particulate matter should not be used.

HOW SUPPLIED

Storage And Handling

Dosage Forms And Strengths

  • MESNEX injection: 1 g Multidose Vial, 100 mg/mL
  • MESNEX tablets: 400 mg film-coated tablets with functional score
MESNEX (mesna) injection 100 mg/mL

NDC 0338-1305-01

1 g Multidose Vial, Box of 1 vial of 10 mL

NDC 0338-1305-03

1 g Multidose Vial, Box of 10 vials of 10 mL

Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

MESNEX (mesna) tablets

NDC 67108-3565-9

400 mg scored tablets packaged in box of 10 tablets

Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Revised: Mar 2014

Last reviewed on RxList: 4/1/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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