Mesna

MESNA — mesna injection, solution
Fresenius Kabi USA, LLC

1 INDICATIONS AND USAGE

Mesna Injection is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis.
Limitation of Use:Mesna Injection is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia.

2 DOSAGE AND ADMINISTRATION

2.1 Intravenous Dosing

Mesna Injection 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 Injection 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
Mesna injection1 240 mg/m2 240 mg/m2 240 mg/m2

1 The 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 Injection to ifosfamide should be maintained.

2.2 Intravenous and Oral Dosing


Mesna Injection 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

0 Hours 2 Hours 6 Hours
Ifosfamide 1.2 g/m2
Mesna injection1 240 mg/m2
Mesna tablets 480 mg/m2 480 mg/m2

1 The 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.
The efficacy and safety of this ratio of intravenous and oral mesna 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 mesna should repeat the dose or receive intravenous Mesna Injection.

2.3 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 Mesna Injection is given according to the recommended dosage schedule, dosage reductions or discontinuation of ifosfamide therapy may be required.

2.4 Preparation for Intravenous Administration and Stability

Preparation
Determine the volume of Mesna Injection for the intended dose.
Dilute the volume of Mesna 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 Mesna Injection multiple dose 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 Mesna Injection with epirubicin, cyclophosphamide, cisplatin, carboplatin, and nitrogen mustard.
The benzyl alcohol contained in Mesna Injection vials can reduce the stability of ifosfamide. Ifosfamide and Mesna Injection 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 Mesna Injection 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.

3 DOSAGE FORMS AND STRENGTHS

  • Mesna Injection: 1 gram per 10 mL (100 mg per mL) Multiple Dose Vial

4 CONTRAINDICATIONS

Mesna Injection is contraindicated in patients known to be hypersensitive to mesna or to any of the excipients [see Warnings and Precautions (5.1)].

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

Mesna may cause systemic hypersensitivity reactions, including anaphylaxis. These reactions may include fever, cardiovascular symptoms (hypotension, tachycardia), acute renal impairment, hypoxia, respiratory distress, urticaria, angioedema, laboratory signs of disseminated intravascular coagulation, hematological abnormalities, increased liver enzymes, nausea, vomiting, arthralgia, and myalgia. These reactions may occur with the first exposure or after several months of exposure. Monitor for signs or symptoms. Discontinue mesna and provide supportive care.

5.2 Dermatologic Toxicity

Drug rash with eosinophilia and systemic symptoms and bullous and ulcerative skin and mucosal reactions, consistent with Stevens-Johnson syndrome or toxic epidermal necrolysis have occurred. Mesna may cause skin and mucosal reactions characterized by urticaria, rash, erythema, pruritus, burning sensation, angioedema, periorbital edema, flushing and stomatitis. These reactions may occur with the first exposure or after several months of exposure. Discontinue mesna and provide supportive care.

5.3 Benzyl Alcohol Toxicity

Serious adverse reactions including fatal reactions and the “gasping syndrome” occurred in premature neonates and low-birth weight infants who received benzyl alcohol dosages of 99 to 234 mg/kg/day (blood levels of benzyl alcohol were 0.61 to 1.378 mmol/L). Symptoms associated with “gasping syndrome” and other potential adverse reactions include gradual neurological deterioration, seizures, intracranial hemorrhage, hematological abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Premature neonates and low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. The minimum amount of benzyl alcohol at which toxicity may occur is not known. Mesna injection contains 10.4 mg/mL of the preservative benzyl alcohol. Avoid use of Mesna Injection in premature neonates and low-birth weight infants. [see Use in Specific Populations (8.4)].

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