MESNA
Generic: MESNA
Basic Information
Manufacturer
Ingenus Pharmaceuticals, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
90d64539-33ad-47e8-9de7-17d6c5baaba4
Indications & Usage
1 INDICATIONS AND USAGE Mesna is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis.
Limitation of Use: Mesna is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia.
Mesna is a cytoprotective agent indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis.
( 1 ) Limitation of Use: Mesna is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia.
( 1 )
Limitation of Use: Mesna is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia.
Mesna is a cytoprotective agent indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis.
( 1 ) Limitation of Use: Mesna is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia.
( 1 )
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 Ingenus Pharmaceuticals, LLC at 1-877-748-1970 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 reaction data are available from four Phase 1 studies in which single oral doses of 600-2400 mg of mesna tablets were administered to a total of 82 healthy volunteers.
In two Phase 1 multiple-dose studies where healthy volunteers received mesna tablets alone or intravenous MESNEX followed by repeated doses of mesna tablets, flatulence and rhinitis were reported.
Additional adverse reactions in healthy volunteers receiving mesna alone included 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, mesna was commonly associated with a rapid (within 24 hours) decrease in lymphocyte count, which was generally reversible within one week of administration.
Because mesna is used in combination with ifosfamide or ifosfamide-containing chemotherapy regimens, it is difficult to distinguish the adverse reactions which may be due to mesna from those caused by the concomitantly administered cytotoxic agents.
Adverse reactions reasonably associated with mesna administered 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 Mesna in combination with Ifosfamide-containing Regimens Mesna Regimen Intravenous-Oral-Oral Intravenous dosing of ifosfamide and MESNEX followed by oral doses of mesna according to the applicable dosage schedule [see Dosage and Administration (2) ] .
N exposed 119 (100%) Incidence of AEs 106 (89.1%) Nausea 64 (53.8) Vomiting 45 (37.8) Constipation 21 (17.6) Leukopenia 21 (17.6) Fatigue 24 (20.2) Fever 18 (15.1) Anorexia 19 (16.0) Thrombocytopenia 16 (13.4) Anemia 21 (17.6) Granulocytopenia 15 (12.6) Asthenia 21 (17.6) Abdominal Pain 18 (15.1) Alopecia 13 (10.9) Dyspnea 11 (9.2) Chest Pain 11 (9.2) Hypokalemia 11 (9.2) Diarrhea 17 (14.3) Dizziness 5 (4.2) Headache 13 (10.9) Pain 10 (8.4) Sweating Increased 2 (1.7) Back Pain 6 (5.0) Hematuria 7 (5.9) Injection Site Reaction 10 (8.4) Edema 9 (7.6) Edema Peripheral 8 (6.7) Somnolence 12 (10.1) Anxiety 4 (3.4) Confusion 6 (5.0) Face Edema 5 (4.2) Insomnia 11 (9.2) Coughing 10 (8.4) Dyspepsia 6 (5.0) Hypotension 6 (5.0) Pallor 6 (5.0) Dehydration 7 (5.9) Pneumonia 8 (6.7) Tachycardia 7 (5.9) Flushing 6 (5.0) 6.2 Postmarketing Experience The following adverse reactions have been reported in the postmarketing experience of patients receiving mesna in combination with ifosfamide or similar drugs, making it difficult to distinguish the adverse reactions which may be due to mesna from those caused by the concomitantly administered cytotoxic agents.
Because these reactions are reported from a population of unknown size, precise estimates of frequency cannot be made.
Cardiovascular : Hypertension Gastrointestinal : Dysgeusia Hepatobiliary : Hepatitis Nervous System : Convulsion Respiratory : Hemoptysis
• 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 Ingenus Pharmaceuticals, LLC at 1-877-748-1970 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 reaction data are available from four Phase 1 studies in which single oral doses of 600-2400 mg of mesna tablets were administered to a total of 82 healthy volunteers.
In two Phase 1 multiple-dose studies where healthy volunteers received mesna tablets alone or intravenous MESNEX followed by repeated doses of mesna tablets, flatulence and rhinitis were reported.
Additional adverse reactions in healthy volunteers receiving mesna alone included 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, mesna was commonly associated with a rapid (within 24 hours) decrease in lymphocyte count, which was generally reversible within one week of administration.
Because mesna is used in combination with ifosfamide or ifosfamide-containing chemotherapy regimens, it is difficult to distinguish the adverse reactions which may be due to mesna from those caused by the concomitantly administered cytotoxic agents.
Adverse reactions reasonably associated with mesna administered 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 Mesna in combination with Ifosfamide-containing Regimens Mesna Regimen Intravenous-Oral-Oral Intravenous dosing of ifosfamide and MESNEX followed by oral doses of mesna according to the applicable dosage schedule [see Dosage and Administration (2) ] .
N exposed 119 (100%) Incidence of AEs 106 (89.1%) Nausea 64 (53.8) Vomiting 45 (37.8) Constipation 21 (17.6) Leukopenia 21 (17.6) Fatigue 24 (20.2) Fever 18 (15.1) Anorexia 19 (16.0) Thrombocytopenia 16 (13.4) Anemia 21 (17.6) Granulocytopenia 15 (12.6) Asthenia 21 (17.6) Abdominal Pain 18 (15.1) Alopecia 13 (10.9) Dyspnea 11 (9.2) Chest Pain 11 (9.2) Hypokalemia 11 (9.2) Diarrhea 17 (14.3) Dizziness 5 (4.2) Headache 13 (10.9) Pain 10 (8.4) Sweating Increased 2 (1.7) Back Pain 6 (5.0) Hematuria 7 (5.9) Injection Site Reaction 10 (8.4) Edema 9 (7.6) Edema Peripheral 8 (6.7) Somnolence 12 (10.1) Anxiety 4 (3.4) Confusion 6 (5.0) Face Edema 5 (4.2) Insomnia 11 (9.2) Coughing 10 (8.4) Dyspepsia 6 (5.0) Hypotension 6 (5.0) Pallor 6 (5.0) Dehydration 7 (5.9) Pneumonia 8 (6.7) Tachycardia 7 (5.9) Flushing 6 (5.0) 6.2 Postmarketing Experience The following adverse reactions have been reported in the postmarketing experience of patients receiving mesna in combination with ifosfamide or similar drugs, making it difficult to distinguish the adverse reactions which may be due to mesna from those caused by the concomitantly administered cytotoxic agents.
Because these reactions are reported from a population of unknown size, precise estimates of frequency cannot be made.
Cardiovascular : Hypertension Gastrointestinal : Dysgeusia Hepatobiliary : Hepatitis Nervous System : Convulsion Respiratory : Hemoptysis