MESNEX mesna 100 mg/mL Injection, Solution
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Mucolytics class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Mesna is used to reduce the risk of hemorrhagic cystitis (a condition that causes inflammation of the bladder and can result in serious bleeding) in people who receive ifosfamide (a medication used for the treatment of cancer). Mesna is in a class of medications called cytoprotectants. It works by protecting against some of the harmful effects of certain chemotherapy medications.
Read the full MedlinePlus article ↗- Great question — mesna isn't your cancer treatment. It's a protective medication given alongside your chemotherapy drug ifosfamide. Ifosfamide breaks down in your body into toxic b...
- Why am I being given mesna? I thought I was here for chemotherapy.
- It depends on your treatment schedule — your doctor may use one of two approaches. Some patients receive all doses through an IV line. Others start with an IV dose and then take or...
- Do I take mesna as a pill or does it go through an IV?
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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1.04 mg / 1 mL
UNII LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
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0.25 mg / 1 mL
UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
3 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $1.10 | $10.95 / 10 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J9209 | $1.305 / J9209 unit | — |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| mesna 100 mg/mL 00143-9260-01 | Hikma | 1 vial | — | AP | FDA listed | — |
| Mesnex 100 mg/mLthis 00338-1305-01 | Baxter | 1 vial | — | AP | FDA listed | — |
| Mesnex 100 mg/mL 00338-1307-05 | Baxter | 1 vial | — | AP | FDA listed | — |
| Mesna 100 mg/mL 10019-0951-05 | Baxter | 1 vial | — | AP | FDA listed | — |
| Mesna 100 mg/mL 10019-0953-01 | Baxter | 1 vial | — | AP | FDA listed | — |
| Mesna 100 mg/mL 25021-0201-10 | Sagent | 1 vial | — | AP | FDA listed | — |
| Mesna 100 mg/mL 55150-0520-01 | Eugia | 1 vial | — | AP | FDA listed | — |
| Mesna 100 mg/mL 63323-0733-10 | Fresenius | 10 vials | — | AP | FDA listed | — |
| Mesna 100 mg/mL 68083-0161-01 | Gland | 1 vial | — | AP | FDA listed | — |
| Mesnex 100 mg/mL 83703-0559-01 | Bamboo | 1 vial | — | AP | FDA listed | — |
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⏳ Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
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🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)
🔬 Reported adverse events (FAERS)
Top reported reactions
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00338-1305-01 You're viewing this | 1 VIAL, MULTI-DOSE in 1 BOX (0338-1305-01) / 10 mL in 1 VIAL, MULTI-DOSE | 1988-12-30 | Active |
| 00338-1305-03 | 10 VIAL, MULTI-DOSE in 1 BOX (0338-1305-03) / 10 mL in 1 VIAL, MULTI-DOSE | 1988-12-30 | Active |
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🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE 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. MESNEX is a cytoprotective agent indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis.
( 1 ) Limitation of Use: MESNEX is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION MESNEX may be given on a fractionated dosing schedule of three bolus intravenous injections or a single bolus injection followed by two oral administrations of MESNEX tablets as outlined below. The dosing schedule should be repeated on each day that ifosfamide is administered. When the dosage of ifosfamide is adjusted, the ratio of MESNEX to ifosfamide should be maintained.
( 2 ) Intravenous Dosing Schedule: 0 Hours 4 Hours 8 Hours Ifosfamide 1.2 g/m 2 -- -- MESNEX injection 240 mg/m 2 240 mg/m 2 240 mg/m 2 Intravenous and Oral Dosing Schedule: 0 Hours 2 Hours 6 Hours Ifosfamide 1.2 g/m 2 -- -- MESNEX injection 240 mg/m 2 -- -- MESNEX tablets -- 480 mg/m 2 480 mg/m 2 Maintain sufficient urinary output, as required for ifosfamide treatment, and monitor urine for the presence of hematuria. ( 2.3 )
2.1Intravenous 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/m 2 – – MESNEX injection 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 MESNEX to ifosfamide should be maintained. 240 mg/m 2 240 mg/m 2 240 mg/m 2
2.2Intravenous 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/m 2 – – MESNEX injection 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 MESNEX to ifosfamide should be maintained. 240 mg/m 2 – – MESNEX tablets – 480 mg/m 2 480 mg/m 2 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/m 2 .
Patients who vomit within two hours of taking oral MESNEX should repeat the dose or receive intravenous MESNEX.
2.3Monitoring 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.
2.4Preparation 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 e…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS • MESNEX (mesna) injection: 1 g Multidose Vial, 100 mg/mL • MESNEX (mesna) tablets: 400 mg film-coated tablets with functional score • Injection: 1g (100 mg/mL) Multidose vials ( 3 ) • Tablets: 400 mg with functional score ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS MESNEX is contraindicated in patients known to be hypersensitive to mesna or to any of the excipients [see Warnings and Precautions (5.1) ]. • Known hypersensitivity to mesna or to any of the excipients, including benzyl alcohol. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Hypersensitivity reactions: Anaphylactic reactions have been reported. Less severe hypersensitivity reactions may also occur. Monitor patients.
If a reaction occurs, discontinue MESNEX and provide supportive care. ( 5.1 ) • Dermatologic toxicity: Skin rash with eosinophilia and systemic symptoms, Stevens-Johnson syndrome, and toxic epidermal necrolysis have occurred. Skin rash, urticaria, and angioedema have also been seen.
Monitor patients. If a reaction occurs, discontinue MESNEX and provide supportive care. ( 5.2 ) • Benzyl alcohol toxicity: Serious and fatal adverse reactions can occur in premature neonates and low-birth weight infants treated with benzyl alcohol-preserved drugs, including MESNEX injection.
Avoid use in premature neonates and low-birth weight infants. ( 5.3 ) • Laboratory test alterations: False positive tests for urinary ketones and interference with enzymatic CPK activity tests have been seen. ( 5.4 )
5.1Hypersensitivity Reactions MESNEX 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 MESNEX and provide supportive care.
5.2Dermatologic 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. MESNEX 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 MESNEX and provide supportive care.
5.3Benzyl 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. MESNEX injection contains 10.4 mg/mL of the preservative benzyl alcohol.
Avoid use of MESNEX injection in premature neonates and low-birth weight infants. MESNEX tablets do not contain benzyl alcohol [see Use in Specific Populations (8.4) ].
5.4Laboratory Test Interferences False-Positive Urine Tests for Ketone Bodies A false positive test for urinary ketones may arise in patients treated with MESNEX when using nitroprusside sodium-based urine tests (including dipstick tests). The addition of glacial acetic acid can be used to differentiate between a false positive result (cherry-red color that fades) and a true positive result (red-violet color that intensifies). False-Negative Tests for Enzymatic CPK Activity MESNEX may interfere with enzymatic creatinine phosphokinase (CPK) activity tests that use a thiol compound (e.g., N-acetylcysteine) for CPK reactiviation.
This may result in a falsely low CPK level. False-Positive Tests for Ascorbic Acid MESNEX may cause false-positive reactions in Tillman’s reagent-based urine screening tests for ascorbic acid.
5.5 Use in Patients with a History…
🤒 Adverse Reactions ▾
6 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) ] The most common adverse reactions (> 10%) when MESNEX 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 Baxter Healthcare at 1-866-888-2472, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. MESNEX adverse reaction data are available from four Phase 1 studies in which single intravenous doses of 600-1200 mg MESNEX injection without concurrent chemotherapy were administered to a total of 53 healthy volunteers and single oral doses of 600-2400 mg of MESNEX tablets were administered to a total of 82 healthy volunteers.
The most frequently reported side effects (observed in two or more healthy volunteers) for healthy volunteers receiving single doses of MESNEX injection alone were headache, injection site reactions, flushing, dizziness, nausea, vomiting, somnolence, diarrhea, anorexia, fever, pharyngitis, hyperesthesia, influenza-like symptoms, and coughing. In two Phase 1 multiple-dose studies where healthy volunteers received MESNEX tablets alone or intravenous MESNEX followed by repeated doses of MESNEX tablets, flatulence and rhinitis were reported.
In addition, constipation was reported by healthy volunteers who had received repeated doses of intravenous MESNEX. Additional adverse reactions in healthy volunteers receiving MESNEX alone included injection site reactions, abdominal pain/colic, epigastric pain/burning, mucosal irritation, lightheadedness, back pain, arthralgia, myalgia, conjunctivitis, nasal congestion, rigors, paresthesia, photophobia, fatigue, lymphadenopathy, extremity pain, malaise, chest pain, dysuria, pleuritic pain, dry mouth, dyspnea, and hyperhidrosis.
In healthy volunteers, MESNEX was commonly associated with a rapid (within 24 hours) decrease in lymphocyte count, which was generally reversible within one week of administration. Because MESNEX is used in combination with ifosfamide or ifosfamide-containing chemotherapy regimens, it is difficult to distinguish the adverse reactions which may be due to MESNEX from those caused by the concomitantly administered cytotoxic agents. Adverse reactions reasonably associated with MESNEX administered intravenously and orally in four controlled studies in which patients received ifosfamide or ifosfamide-containing regimens are presented in Table 3.
Table 3: Adverse Reactions in ≥ 5% of Patients Receiving MESNEX in combination with Ifosfamide-containing Regimens MESNEX Regimen Intravenous-Intravenous-Intravenous Intravenous dosing of ifosfamide and MESNEX followed by either intravenous or oral doses of MESNEX according to the applicable dosage schedule [see Dosage and Administration (2) ]. Intravenous-Oral-Oral N exposed 119 (100.0%) 119 (100%) Incidence of AEs 101 (84.9%) 106 (89.1%) Nausea 65 (54.6) 64 (53.8) Vomiting 35 (29.4) 45 (37.8) Constipation 28 (23.5) 21 (17.6) Leukopenia 25 (21.0) 21 (17.6) Fatigue 24 (20.2) 24 (20.2) Fever 24 (20.2) 18 (15.1) Anorexia 21 (17.6) 19 (16.0) Thrombocytopenia 21 (17.6) 16 (13.4) Anemia 20 (16.8) 21 (17.6) Granulocytopenia 16 (13.4) 15 (12.6) Asthenia 15 (1…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS No clinical drug interaction studies have been conducted with MESNEX.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS • Pregnancy: MESNEX in combination with ifosfamide can cause fetal harm. Advise patients of potential risk to a fetus. (8.1) • Lactation: Do not breastfeed.
(8.2) • Females and Males of Reproductive Potential: Advise patients to use effective contraception. Verify pregnancy status prior to initiation of MESNEX in combination with ifosfamide. (8.3) • Pediatric use: In premature neonates and low-birth weight infants, avoid use of benzyl alcohol–containing solutions.
(8.4) • Geriatric use: Dose selection should be cautious. (8.5)
8.1Pregnancy Risk Summary MESNEX is used in combination with ifosfamide or other cytotoxic agents. Ifosfamide can cause fetal harm when administered to a pregnant woman. Refer to the ifosfamide prescribing information for more information on use during pregnancy.
MESNEX injection contains the preservative benzyl alcohol. Because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is unlikely [see Warnings and Precautions (5.3) and Use in Specific Populations (8.4)]. The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data MESNEX is used in combination with ifosfamide or other cytotoxic agents.
Ifosfamide can cause fetal harm including embryo-fetal lethality. Refer to the ifosfamide prescribing information for more information on use during pregnancy. In embryo-fetal development studies, oral administration of mesna to pregnant rats (500, 1000, 1500, and 2000 mg/kg) and rabbits (500 and 1000 mg/kg) during the period of organogenesis revealed no adverse developmental outcomes at doses approximately 10 times the maximum recommended total daily human equivalent dose based on body surface area.
8.2Lactation Risk Summary MESNEX is used in combination with ifosfamide or other cytotoxic agents. Ifosfamide is excreted in breast milk. Refer to the ifosfamide prescribing information for more information on use during lactation.
There are no data on the presence of mesna in human or animal milk, the effect on the breastfed child, or the effect on milk production. MESNEX injection contains the preservative benzyl alcohol. Because benzyl alcohol is rapidly metabolized by a lactating woman, benzyl alcohol exposure in the breastfed infant is unlikely.
However, adverse reactions have occurred in premature neonates and low birth weight infants who received intravenously administered benzyl alcohol-containing drugs [see Warnings and Precautions (5.3) and Use in Specific Populations (8.4)]. Because of the potential for serious adverse reactions in a breastfed child, advise lactating women not to breastfeed during treatment and for 1 week after the last dose of MESNEX or ifosfamide.
8.3Females and Males of Reproductive Potential MESNEX is used in combination with ifosfamide or other cytotoxic agents. Ifosfamide can cause fetal harm when administered to a pregnant woman. Refer to the ifosfamide prescribing information for more information on contraception and effects on fertility.
Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiation of MESNEX in combination with ifosfamide. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with MESNEX in combination with ifosfamide and for 6 months after the last dose. Males Advise males with female partners of reproductive potential to use effective contraception during treatment with MESNEX in combination with ifosfamide and for 3 months after the last dose.
8.4Pediatric Use MESNEX injection contains the preservative benzyl alcohol which has been associated with serious adverse…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary MESNEX is used in combination with ifosfamide or other cytotoxic agents. Ifosfamide can cause fetal harm when administered to a pregnant woman. Refer to the ifosfamide prescribing information for more information on use during pregnancy.
MESNEX injection contains the preservative benzyl alcohol. Because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is unlikely [see Warnings and Precautions (5.3) and Use in Specific Populations (8.4)]. The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data MESNEX is used in combination with ifosfamide or other cytotoxic agents.
Ifosfamide can cause fetal harm including embryo-fetal lethality. Refer to the ifosfamide prescribing information for more information on use during pregnancy. In embryo-fetal development studies, oral administration of mesna to pregnant rats (500, 1000, 1500, and 2000 mg/kg) and rabbits (500 and 1000 mg/kg) during the period of organogenesis revealed no adverse developmental outcomes at doses approximately 10 times the maximum recommended total daily human equivalent dose based on body surface area.
🧒 Pediatric Use ▾
8.4Pediatric Use MESNEX injection contains the preservative benzyl alcohol which has been associated with serious adverse reactions and death when administered intravenously to premature neonates and low birth weight infants . Avoid use of MESNEX injection in premature neonates and low-birth weight infants [see Warnings and Precautions (5.3) ].
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of MESNEX did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. The ratio of ifosfamide to MESNEX should remain unchanged.
🆘 Overdosage ▾
10 OVERDOSAGE There is no known antidote for MESNEX. In a clinical trial, 11 patients received intravenous MESNEX 10 mg/kg to 66 mg/kg per day for 3 to 5 days. Patients also received ifosfamide or cyclophosphamide.
Adverse reactions included nausea, vomiting, diarrhea and fever. An increased rate of these adverse reactions has also been found in oxazaphosphorine-treated patients receiving ≥80 mg MESNEX per kg per day intravenously compared with patients receiving lower doses or hydration treatment only. Postmarketing, administration of 4.5 g to 6.9 g of MESNEX resulted in hypersensitivity reactions including mild hypotension, shortness of breath, asthma exacerbation, rash, and flushing.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Mesna reacts chemically with the urotoxic ifosfamide metabolites, acrolein and 4-hydroxy-ifosfamide, resulting in their detoxification. The first step in the detoxification process is the binding of mesna to 4-hydroxy-ifosfamide forming a non-urotoxic 4-sulfoethylthioifosfamide. Mesna also binds to the double bonds of acrolein and to other urotoxic metabolites and inhibits their effects on the bladder.
12.3Pharmacokinetics Absorption Following oral administration, peak plasma concentrations were reached within 1.5 to 4 hours and 3 to 7 hours for free mesna and total mesna (mesna plus dimesna and mixed disulfides), respectively. Oral bioavailability averaged 58% (range 45 to 71%) for free mesna and 89% (range 74 to 104%) for total mesna based on plasma AUC data from 8 healthy volunteers who received 1200 mg oral or intravenous doses. Food does not affect the urinary availability of orally administered MESNEX.
Distribution Mean apparent volume of distribution (V d ) for mesna is 0.652 ± 0.242 L/kg after intravenous administration which suggests distribution to total body water (plasma, extracellular fluid, and intracellular water). Metabolism Analogous to the physiological cysteine-cystine system, mesna is rapidly oxidized to its major metabolite, mesna disulfide (dimesna). Plasma concentrations of mesna exceed those of dimesna after oral or intravenous administration.
Excretion Following intravenous administration of a single 800 mg dose, approximately 32% and 33% of the administered dose was eliminated in the urine in 24 hours as mesna and dimesna, respectively. Mean plasma elimination half-lives of mesna and dimesna are 0.36 hours and 1.17 hours, respectively. Mesna has a plasma clearance of
1.23L/h/kg.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Mesna reacts chemically with the urotoxic ifosfamide metabolites, acrolein and 4-hydroxy-ifosfamide, resulting in their detoxification. The first step in the detoxification process is the binding of mesna to 4-hydroxy-ifosfamide forming a non-urotoxic 4-sulfoethylthioifosfamide. Mesna also binds to the double bonds of acrolein and to other urotoxic metabolites and inhibits their effects on the bladder.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING 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] If MESNEX is co-administered with ifosfamide, refer to the ifosfamide prescribing information for safe handling instructions. 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]
📋 Description ▾
11 DESCRIPTION MESNEX (mesna) is a detoxifying agent to inhibit the hemorrhagic cystitis induced by ifosfamide. The active ingredient, mesna, is a synthetic sulfhydryl compound designated as sodium-2-mercaptoethane sulfonate with a molecular formula of C 2 H 5 NaO 3 S 2 and a molecular weight of 164.18. Its structural formula is as follows: HS–CH 2 –CH 2 SO 3 –Na + MESNEX injection is a sterile, nonpyrogenic, aqueous solution of clear and colorless appearance in clear glass multidose vials for intravenous administration.
MESNEX injection contains 100 mg/mL mesna, 0.25 mg/mL edetate disodium and sodium hydroxide for pH adjustment. MESNEX injection multidose vials also contain 10.4 mg/mL of benzyl alcohol as a preservative. The solution has a pH range of 7.5-8.5.
MESNEX tablets are white, oblong, scored biconvex film-coated tablets with the imprint M4. They contain 400 mg mesna. The excipients are calcium phosphate, cornstarch, hydroxypropylmethylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, simethicone, and titanium dioxide.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information). Hypersensitivity • Advise the patient to discontinue MESNEX and seek immediate medical attention if any signs or symptoms of a hypersensitivity reaction, including systemic anaphylactic reactions occur [see Warnings and Precautions (5.1) ]. Dosing Instructions • Advise the patient to take MESNEX at the exact time and in the exact amount as prescribed.
Advise the patient to contact their healthcare provider if they vomit within 2 hours of taking oral MESNEX, or if they miss a dose of oral MESNEX [see Dosage and Administration (2.2) ]. Hemorrhagic Cystitis • MESNEX does not prevent hemorrhagic cystitis in all patients nor does it prevent or alleviate any of the other adverse reactions or toxicities associated with ifosfamide. Advise the patient to report to their healthcare provider if his/her urine has turned a pink or red color [see Dosage and Administration (2.3) ]. • Advise the patient to drink 1 to 2 liters of fluid each day during MESNEX therapy [see Dosage and Administration (2.3) ].
Dermatologic Toxicity • Advise the patient that Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms and bullous and ulcerative skin and mucosal reactions have occurred with MESNEX. Advise the patient to report to their healthcare provider if signs and symptoms of these syndromes occur [see Warnings and Precautions (5.2) ]. Benzyl Alcohol Toxicity • Advise patients that serious adverse reactions are associated with the benzyl alcohol found in MESNEX and other medications in premature neonates and low-birth weight infants [see Warnings and Precautions (5.3) and Use in Specific Populations (8.4) ].
Embryo-Fetal Toxicity • MESNEX is used in combination with ifosfamide. Ifosfamide or other cytotoxic agents can cause fetal harm when administered to a pregnant woman. Inform female patients of the risk to a fetus and potential loss of the pregnancy.
Advise females to inform their healthcare provider if they are pregnant or become pregnant [see Use in Specific Populations (8.1) ]. Contraception • Advise females of reproductive potential to use effective contraception during treatment with MESNEX in combination with ifosamide and for 6 months after the last dose [see Use in Specific Populations (8.3)] . • Advise male patients with female partners of reproductive potential to use effective contraception during treatment with MESNEX in combination with ifosamide and for 3 months after the last dose [see Use in Specific Populations (8.3) ].
Lactation • Advise lactating women not to breastfeed during treatment with MESNEX or ifosfamide and for 1 week after the last dose [see Use in Specific Populations (8.2) ].
💬 Patient Medication Information ▾
Patient Information MESNEX (MES-nex) (mesna) tablets MESNEX (MES-nex) (mesna) injection What is the most important information I should know about MESNEX? MESNEX can cause serious allergic reactions and skin reactions. These serious reactions can happen the first time you are treated with MESNEX or after several months of treatment with MESNEX.
Stop treatment with MESNEX and go to the nearest hospital emergency room right away if you develop any of the symptoms listed below: • fever • swelling of your face, lips, mouth, or tongue • trouble breathing or wheezing • itching • burning • skin rash or hives • skin redness or swelling • skin blisters or peeling • feel lightheaded or faint • feel like your heart is racing • nausea • vomiting • joint or muscle aches • mouth sores See “ What are the possible side effects of MESNEX? ” for more information about side effects.
What is MESNEX? MESNEX is a prescription medicine used to reduce the risk of inflammation and bleeding of the bladder (hemorrhagic cystitis) in people who receive ifosfamide (a medicine used to treat cancer). MESNEX is not for use to reduce the risk of blood in the urine (hematuria) due to other medical conditions.
Do not take MESNEX tablets or receive MESNEX by intravenous (IV) infusion if you are allergic to mesna or any of the ingredients in MESNEX. See the end of this leaflet for a complete list of ingredients in MESNEX. Before you take or receive MESNEX, tell your healthcare provider about all of your medical conditions, including if you: • are allergic to any medicines • are pregnant or plan to become pregnant.
Females who are able to become pregnant: o Your healthcare provider will verify if you are pregnant or not before you start treatment with MESNEX and ifosfamide. o You should use effective birth control (contraception) during treatment with MESNEX and ifosfamide and for 6 months after the last dose. o Tell your healthcare provider if you become pregnant during treatment with MESNEX and ifosfamide. Males with female partners who are able to become pregnant should use effective birth control during treatment with MESNEX and ifosfamide and for 3 months after the last dose.
You should also read the ifosfamide Prescribing Information for important pregnancy, contraception, and infertility information. • are breastfeeding or plan to breastfeed. It is not known if MESNEX passes into your breast milk. Do not breastfeed during treatment and for 1 week after the last dose of MESNEX or ifosfamide.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How will I receive MESNEX? • MESNEX is given on the same day that you receive ifosfamide. • MESNEX can be given by an intravenous (IV) infusion into a vein or tablets taken by mouth. • You will receive MESNEX in one of two ways: o MESNEX intravenous (IV) infusion into a vein at the time you receive ifosfamide and 4 and 8 hours after you receive ifosfamide, OR o MESNEX intravenous (IV) infusion into a vein at the time you receive ifosfamide and MESNEX tablets taken by mouth 2 and 6 hours after you receive ifosfamide. • Take MESNEX tablets at the exact times and the exact dose your healthcare provider tells you to take it. • During treatment with MESNEX intravenous (IV) infusion or MESNEX tablets, you should drink 4 to 8 cups of liquid (1 to 2 liters) each day. • Tell your healthcare provider if you: o vomit within 2 hours of taking MESNEX tablets by mouth o miss a dose of MESNEX tablets o have pink or red colored urine What are the possible side effects of MESNEX?
MESNEX may cause serious side effects, including: See “What is the most important information I should know about MESNEX?” • MESNEX that is given by intravenous (IV) infusion contains the preservative benzyl alcohol. Benzyl alcohol has been shown to cause serious side effects and death in premature newborns and low-birth weight babies. Avoid use of MESNEX injecti…