MESNA 400 mg/1
MESNA · TABLET, FILM COATED · Ingenus Pharmaceuticals, LLC
MESNA is a tablet, film coated containing mesna at 400 mg/1, taken oral. Manufactured by Ingenus Pharmaceuticals, LLC.
Key Facts
- Brand Name
- MESNA
- Generic Name
- MESNA
- NDC Code (Product)
50742-354- Manufacturer
- Ingenus Pharmaceuticals, LLC
- Strength
- 400 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA218871
- Marketing Start
- 01/14/2025
Recall History
Infusion Options, Inc.
Lack of Assurance of Sterility
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Mesna Injection is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. Mesna Injection is a cytoprotective agent indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. ( 1 ) Limitation of Use: Mesna Injection is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia. ( 1 ) Limitation of Use: Mesna Injection is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Mesna injection may be given on a fractionated dosing schedule of three bolus intravenous injections or a single bolus injection followed by two oral administrations of mesna 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 mesna to ifosfamide should be maintained. ( 2 ) Intravenous Dosing Schedule: 0 Hours 4 Hours 8 Hours Ifosfamide 1.2 g/m 2 - - Mesna 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 - - Mesna injection 240 mg/m 2 - - Mesna 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 ) 2.1 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 t…
Contraindications
4 CONTRAINDICATIONS Mesna 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 in mesna, including benzyl alcohol. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS No clinical drug interaction studies have been conducted with mesna.
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 mesna 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 Sagent Pharmaceuticals at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical 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. Mesna adverse reactio…
Frequently Asked Questions
What is MESNA used for?
MESNA contains MESNA. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is MESNA a controlled substance?
MESNA is not classified as a controlled substance by the DEA.
What is the generic name for MESNA?
The generic name for MESNA is MESNA. There are 8 other brand versions of MESNA.
What is the NDC code for MESNA 400 mg/1?
The NDC (National Drug Code) for MESNA 400 mg/1 is 50742-354, listed by Ingenus Pharmaceuticals, LLC.