Professional Information
Mesna (Systemic)
VA CLASSIFICATION
Primary: AD900
Commonly used brand name(s): MESNEX; Uromitexan.
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).
Category:
Hemorrhagic cystitis prophylactic—
Indications
Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.
Accepted
Hemorrhagic cystitis, oxazaphosphorine-induced (prophylaxis)—Mesna is indicated to reduce the incidence of ifosfamide-induced {01} or [cyclophosphamide-induced] {03} {04} {05} hemorrhagic cystitis. Mesna is not effective in preventing hematuria due to other pathologic conditions such as thrombocytopenia {01}, and does not affect other toxicities of oxazaphosphorines {02}.
Pharmacology/Pharmacokinetics
Physicochemical characteristics:
Molecular weight—
164.18 {06} {09}
Other characteristics
Mesna injection: pH is 6.5 to 8.5 {01}.
Mechanism of action/Effect:
Mesna disulfide, which is physically inert {02}, is reduced in the kidney (in the renal tubular epithelium {02}) to mesna, which binds to and detoxifies urotoxic metabolites of oxazophosphorines (for ifosfamide, 4-hydroxyifosfamide and acrolein) {01}.
Distribution:
Apparent volume of distribution (Vol D)—0.652 liter per kg {01}.
Biotransformation:
Rapid, by oxidation to one metabolite, mesna disulfide (dimesna) {01} {02}.
Half-life:
Mesna—0.36 hour {01}.
Dimesna—1.17 hours {01}.
Elimination:
Renal, rapid {02}, by glomerular filtration {02}; 32% as mesna and 33% as dimesna {01}.
Precautions to Consider
Carcinogenicity
Studies have not been done {01}.
Mutagenicity
Mesna was not found to be mutagenic in the Ames Salmonella typhimurium test, mouse micronucleus assay, and frequency of sister chromatid exchange and chromosomal aberrations in PHA-stimulated lymphocytes in in vitro assays {01}.
Pregnancy/Reproduction
Pregnancy—
Studies in humans have not been done.
Studies in rats and rabbits at oral doses up to 1000 mg per kg of body weight (mg/kg) have not shown that mesna causes adverse effects on the fetus {01}.
FDA Pregnancy Category B.
Breast-feeding
It is not known whether mesna is distributed into breast milk {01}. However, problems in humans have not been documented.
Pediatrics
Appropriate studies on the relationship of age to the effects of mesna have not been performed in the pediatric population. However, no pediatrics-specific problems have been documented to date.
Geriatrics
No information is available on the relationship of age to the effects of mesna in geriatric patients.
Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):
With physiology/laboratory test values
Ketones, urinary (false-positive results may be produced; in this test, a red-violet color develops, which returns to violet with the addition of glacial acetic acid {01})
Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).
Risk-benefit should be considered when the following medical problems exist
» Sensitivity to mesna{01}
» Sensitivity to other thiol compounds{09}
Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):
Examination of urine for microscopic hematuria (recommended prior to administration of each dose of ifosfamide or cyclophosphamide and mesna {01})
Side/Adverse Effects
Note: Since mesna is used in combination with ifosfamide and other chemotherapeutic agents with documented toxicities, it is difficult to distinguish the adverse reactions that may be due to mesna from those caused by the concomitantly administered cytostatic agents {09}.
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:
Those indicating need for medical attention
Incidence rare
Allergic reaction{01}{03} (skin rash or itching)
Those indicating need for medical attention only if they continue or are bothersome
Incidence less frequent
Diarrhea{01}{02}
nausea or vomiting{01} {02}
unpleasant taste{01}{02}
Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Mesna (Systemic).
In providing consultation, consider emphasizing the following selected information (» = major clinical significance):
Before using this medication
» Conditions affecting use, especially:
Sensitivity to mesna or other thiol compounds
Proper use of this medication
» Proper dosing
Side/adverse effects
Signs of potential side effects, especially allergic reaction
General Dosing Information
Patients receiving mesna should be under supervision of a physician experienced in cancer chemotherapy.
Mesna injection has been developed as an agent to prevent ifosfamide-induced hemorrhagic cystitis {09}. It will not prevent or alleviate any of the other adverse reactions or toxicities associated with ifosfamide therapy {09}.
Mesna does not prevent hemorrhagic cystitis in all patients {09}. Up to 6% of patients treated with mesna have developed hematuria {09}. If hematuria develops when mesna is given with ifosfamide according to the recommended dosage schedule, depending on the severity of the hematuria, dosage reductions or discontinuation of ifosfamide therapy may be initiated {09}.
Parenteral Dosage Forms
MESNA INJECTION
Usual adult and adolescent dose
Prophylaxis of ifosfamide-induced hemorrhagic cystitis
Intravenous injection, rapid, in a dosage equal to 20% of the ifosfamide dosage (w/w) at the time of ifosfamide administration and four and eight hours after each dose of ifosfamide (i.e., the total daily dose of mesna is equal to 60% of the total daily dose of ifosfamide) each day that ifosfamide is administered {01}. For example, patients receiving a daily ifosfamide dose of 1.2 grams per square meter of body surface area should receive 240 mg of mesna per square meter of body surface area at zero, four, and eight hours after administration of each dose of ifosfamide {01}.
Note: If the dose of ifosfamide is adjusted, the dose of mesna should be adjusted accordingly {01}.
Usual pediatric dose
Dosage has not been established.
Strength(s) usually available
U.S.—
100 mg per mL (Rx) [MESNEX]
Canada—
100 mg per mL (Rx) [Uromitexan]
Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by the manufacturer.
Preparation of dosage form:
Mesna injection is prepared for intravenous administration by adding it to a sufficient quantity of 5% dextrose injection, 5% dextrose and sodium chloride injection, 0.9% sodium chloride injection, or lactated Ringer's injection to produce a solution containing 20 mg of mesna per mL {01}.
Stability:
Diluted solutions of mesna are chemically and physically stable for 24 hours at 25 °C (77 °F) {01}. However, it is recommended that diluted solutions be refrigerated and used within 6 hours {01}. Because exposure to oxygen causes mesna to be oxidized to dimesna, any unused portion of an ampul should be discarded {01}.
Incompatibilities:
Mesna injection is incompatible with cisplatin injection {01}.
Revised: 09/30/1997
References
Note: References used in the development and subsequent revisions of this monograph have not been incorporated into the database and therefore are not listed below.
- MESNEX package insert (Degussa—U.S.), 1/89.
- Zalupski M, Baker LH. Ifosfamide. J Natl Cancer Inst 1988 Jun 15; 80(8): 556-66.
- Drug Intell Clin Pharm 1988 Nov; 22: 913-4.
- Reviewers' responses to panel question #4, 1990 revision.
- Panel comment, 1990 revision.
- Uromitexan package insert (Bristol-Myers—Canada), Rev 9/88, Rec 8/97.
- Shaw IC, Graham MI. Mesna—A short review. Cancer Treat Rev 1987 Jun; 14(2): 67-86.
- Burkert H. Clinical overview of mesna. Cancer Treat Rev 1983; 10 (Suppl A): 175-81.
- MESNEX package insert (Meadjohnson—US), Rev 5/95, Rec 7/97.
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