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Mesna (Mesna) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The following are discussed in more detail in other sections of the labeling.

  • Hypersensitivity Reactions [see Warnings and Precautions ]
  • Dermatological Toxicity [see Warnings and Precautions]
  • Benzyl Alcohol Toxicity [see Warnings and Precautions ]
  • Laboratory Test Interferences [see Warnings and Precautions]
  • Use in Patients with a History of Adverse Reactions to Thiol Compounds [see Warnings and Precautions ]

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 to 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 two Phase 1 multiple-dose studies where healthy volunteers received mesna tablets alone or intravenous mesna followed by repeated doses of mesna tablets, flatulence and rhinitis were reported. 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 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 Mesna in combination with Ifosfamide-containing Regimens

1 Intravenous dosing of ifosfamide and mesna followed by either intravenous or oral doses of mesna according to the applicable dosage schedule [see Dosage and Administration (2)].

Mesna Regimen Intravenous-Intravenous-Intravenous1 Intravenous-Oral-Oral1
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 (12.6) 21 (17.6)
Abdominal Pain 14 (11.8) 18 (15.1)
Alopecia 12 (10.1) 13 (10.9)
Dyspnea 11 (9.2) 11 (9.2)
Chest Pain 10 (8.4) 11 (9.2)
Hypokalemia 10 (8.4) 11 (9.2)
Diarrhea 9 (7.6) 17 (14.3)
Dizziness 9 (7.6) 5 (4.2)
Headache 9 (7.6) 13 (10.9)
Pain 9 (7.6) 10 (8.4)
Sweating Increased 9 (7.6) 2 (1.7)
Back Pain 8 (6.7) 6 (5.0)
Hematuria 8 (6.7) 7 (5.9)
Injection Site Reaction 8 (6.7) 10 (8.4)
Edema 8 (6.7) 9 (7.6)
Edema Peripheral 8 (6.7) 8 (6.7)
Somnolence 8 (6.7) 12 (10.1)
Anxiety 7 (5.9) 4 (3.4)
Confusion 7 (5.9) 6 (5.0)
Face Edema 6 (5.0) 5 (4.2)
Insomnia 6 (5.0) 11 (9.2)
Coughing 5 (4.2) 10 (8.4)
Dyspepsia 4 (3.4) 6 (5.0)
Hypotension 4 (3.4) 6 (5.0)
Pallor 4 (3.4) 6 (5.0)
Dehydration 3 (2.5) 7 (5.9)
Pneumonia 2 (1.7) 8 (6.7)
Tachycardia 1 (0.8) 7 (5.9)
Flushing 1 (0.8) 6 (5.0)

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



REPORTS OF SUSPECTED MESNA SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Mesna. The information is not vetted and should not be considered as verified clinical evidence.

Possible Mesna side effects / adverse reactions in 15 year old female

Reported by a health professional (non-physician/pharmacist) from Italy on 2011-10-18

Patient: 15 year old female

Reactions: Dizziness, Orthostatic Hypotension

Suspect drug(s):
Cyclophosphamide
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-10-01
    End date: 2011-10-02

Mesna
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-10-01
    End date: 2011-10-02

Other drugs received by patient: Ranitidine; Bactrim; Miconazole Nitrate; Dexamethasone; Fasturtec



Possible Mesna side effects / adverse reactions in 11 year old male

Reported by a individual with unspecified qualification from United States on 2011-10-26

Patient: 11 year old male

Reactions: Hypersensitivity, Angioedema, Hypotension, Disseminated Intravascular Coagulation, Pyrexia, Drug Rash With Eosinophilia and Systemic Symptoms, Eosinophilia, Respiratory Failure, Oliguria, Hypoxia, Leukocytosis, Rash Maculo-Papular, Septic Shock, Leukopenia, Renal Failure Acute

Suspect drug(s):
Mesna
    Dosage: 500 mg/m2, intravenous (not otherwise specified) 1500 mg/m2, intravenous (not otherwise specified)
    Indication: Primitive Neuroectodermal Tumour

Amifostine
    Dosage: 600 mg/m2
    Indication: Primitive Neuroectodermal Tumour

Other drugs received by patient: Cisplatin; Cyclophosphamide; Vincristine



Possible Mesna side effects / adverse reactions in 32 month old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-10-27

Patient: 32 month old female weighing 11.0 kg (24.2 pounds)

Reactions: Fungaemia, Mucosal Inflammation, Febrile Neutropenia, Epistaxis

Adverse event resulted in: hospitalization

Suspect drug(s):
Ifosfamide
    Indication: Sarcoma Metastatic
    Start date: 2011-07-12

Mesna
    Indication: Sarcoma Metastatic
    Start date: 2011-07-12

Doxorubicin HCL
    Indication: Sarcoma Metastatic
    Start date: 2011-07-12

Ifosfamide
    Start date: 2011-07-12

Vincristine Sulfate
    Indication: Sarcoma Metastatic
    Start date: 2011-07-12

Dactinomycin
    Start date: 2011-07-12

Mesna
    Start date: 2011-07-12

Mesna
    Start date: 2011-07-12

Doxorubicin HCL
    Start date: 2011-07-12

Bevacizumab
    Indication: Sarcoma Metastatic
    Start date: 2011-07-12

Dactinomycin
    Indication: Sarcoma Metastatic
    Start date: 2011-07-12

Other drugs received by patient: Ondansetron; Levomepromazine; Cotrim; Acetaminophen; Moviprep; Moviprep; Docusate; Fluconazole



See index of all Mesna side effect reports >>

Drug label data at the top of this Page last updated: 2014-04-30

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