mesna
Generic: MESNA
Basic Information
Manufacturer
Hikma Pharmaceuticals USA Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
8012b97b-4e39-451f-8e04-542d196e8bc6
Indications & Usage
1 INDICATIONS AND USAGE Mesna Injection is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis L imitation of Use: Mesna Injection is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia.
Mesna isa cytoprotective agent indicated asa 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 )
Mesna isa cytoprotective agent indicated asa 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 Hikma Pharmaceuticals USA Inc.
at 1-877-845-0689 or FDA at 1-800-332-1088 or www.fda.gov/medwatch.
"1-800-FDA-1088" 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 intravenous doses of 600-1200 mg mesna Injection without concurrent chemotherapy were administered to a total of 53 healthy volunteers.
The most frequently reported side effects (observed in two or more healthy volunteers) for healthy volunteers receiving single doses of mesna Injection alone were headache, injection site reactions, flushing, dizziness, nausea, vomiting, somnolence, diarrhea, anorexia, fever, pharyngitis, hyperesthesia, influenza-like symptoms, and coughing.
In addition, constipation was reported by healthy volunteers who had received repeated doses of intravenous mesna.
Additional adverse reactions in healthy volunteers receiving mesna 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, 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 intravenously 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 I ntravenous-Intravenous-Intravenous 1 N exposed 119 (100%) Incidence of AEs 101 (84.9%) Nausea 65 (54.6) Vomiting 35 (29.4) Constipation 28 (23.5) Leukopenia 25 (21) Fatigue 24 (20.2) Fever 24 (20.2) Anorexia 21 (17.6) Thrombocytopenia 21 (17.6) Anemia 20 (16.8) Granulocytopenia 16 (13.4) Asthenia 15 (12.6) Abdominal Pain 14 (11.8) Alopecia 12 (10.1) Dyspnea 11 (9.2) Chest Pain 10 (8.4) Hypokalemia 10 (8.4) Diarrhea 9 (7.6) Dizziness 9 (7.6) Headache 9 (7.6) Pain 9 (7.6) Sweating Increased 9 (7.6) Back Pain 8 (6.7) Hematuria 8 (6.7) Injection Site Reaction 8 (6.7) Edema 8 (6.7) Edema Peripheral 8 (6.7) Somnolence 8 (6.7) Anxiety 7 (5.9) Confusion 7 (5.9) Face Edema 6 (5) Insomnia 6 (5) Coughing 5 (4.2) Dyspepsia 4 (3.4) Hypotension 4 (3.4) Pallor 4 (3.4) Dehydration 3 (2.5) Pneumonia 2 (1.7) Tachycardia 1 (0.8) Flushing 1 (0.8) 1 Intravenous dosing of ifosfamide and mesna followed by intravenous doses of mesna according to the applicable dosage schedule.
[see Dosage and Administration (2) ].
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 Hikma Pharmaceuticals USA Inc.
at 1-877-845-0689 or FDA at 1-800-332-1088 or www.fda.gov/medwatch.
"1-800-FDA-1088" 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 intravenous doses of 600-1200 mg mesna Injection without concurrent chemotherapy were administered to a total of 53 healthy volunteers.
The most frequently reported side effects (observed in two or more healthy volunteers) for healthy volunteers receiving single doses of mesna Injection alone were headache, injection site reactions, flushing, dizziness, nausea, vomiting, somnolence, diarrhea, anorexia, fever, pharyngitis, hyperesthesia, influenza-like symptoms, and coughing.
In addition, constipation was reported by healthy volunteers who had received repeated doses of intravenous mesna.
Additional adverse reactions in healthy volunteers receiving mesna 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, 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 intravenously 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 I ntravenous-Intravenous-Intravenous 1 N exposed 119 (100%) Incidence of AEs 101 (84.9%) Nausea 65 (54.6) Vomiting 35 (29.4) Constipation 28 (23.5) Leukopenia 25 (21) Fatigue 24 (20.2) Fever 24 (20.2) Anorexia 21 (17.6) Thrombocytopenia 21 (17.6) Anemia 20 (16.8) Granulocytopenia 16 (13.4) Asthenia 15 (12.6) Abdominal Pain 14 (11.8) Alopecia 12 (10.1) Dyspnea 11 (9.2) Chest Pain 10 (8.4) Hypokalemia 10 (8.4) Diarrhea 9 (7.6) Dizziness 9 (7.6) Headache 9 (7.6) Pain 9 (7.6) Sweating Increased 9 (7.6) Back Pain 8 (6.7) Hematuria 8 (6.7) Injection Site Reaction 8 (6.7) Edema 8 (6.7) Edema Peripheral 8 (6.7) Somnolence 8 (6.7) Anxiety 7 (5.9) Confusion 7 (5.9) Face Edema 6 (5) Insomnia 6 (5) Coughing 5 (4.2) Dyspepsia 4 (3.4) Hypotension 4 (3.4) Pallor 4 (3.4) Dehydration 3 (2.5) Pneumonia 2 (1.7) Tachycardia 1 (0.8) Flushing 1 (0.8) 1 Intravenous dosing of ifosfamide and mesna followed by intravenous doses of mesna according to the applicable dosage schedule.
[see Dosage and Administration (2) ].
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