Mesna Side Effects

Brand Names: Mesnex

Please note - some side effects for Mesna may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Mesna - for the Consumer

Mesna

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Mesna:

Bad taste in mouth; cold symptoms (coughing, sore throat); constipation; diarrhea; dizziness; drowsiness; fever; fluid retention; flushing; headache; loss of appetite; injection site reaction; nausea; pain in arms or legs; paleness; stomach pain; tiredness; vomiting.

Severe allergic reactions (rash; hives; difficulty swallowing or breathing; tightness in the chest; swelling of the mouth, face, lips, hands, eyes, face, throat, or tongue); blood in the urine (pink or red urine); chest pain; difficulty swallowing; fast heartbeat; hoarseness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .

Mesna Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Mesna Tablets:

Bad taste in mouth; cold symptoms (coughing, sore throat); constipation; diarrhea; dizziness; drowsiness; fever; fluid retention; flushing; headache; loss of appetite; nausea; pain in arms or legs; paleness; stomach pain; tiredness; vomiting.

Severe allergic reactions (rash; hives; difficulty swallowing or breathing; tightness in the chest; swelling of the mouth, face, lips, hands, eyes, face, throat, or tongue); blood in the urine (pink or red urine); chest pain; difficulty swallowing; fast heartbeat; hoarseness.

Mesna Side Effects - for the Professional

Mesna

Mesna adverse reaction data are available from four phase I studies in which single IV bolus doses of 600 to 1200 mg Mesna injection without concurrent chemotherapy were administered to a total of 53 subjects.

The most frequently reported side effects (observed in two or more patients) for patients receiving single doses of Mesna injection were headache, injection site reactions, flushing, dizziness, nausea, vomiting, somnolence, diarrhea, anorexia, fever, pharyngitis, hyperaesthesia, influenza-like symptoms, and coughing. In addition, constipation was reported by patients who had received repeated doses of Mesna injection.

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 IV in four controlled studies in which patients received ifosfamide or ifosfamide-containing regimens are presented in Table 2.

Postmarketing Surveillance

Allergic reactions, decreased platelet counts associated with allergic reactions, hypertension, hypotension, increased heart rate, increased liver enzymes, injection site reactions (including pain and erythema), limb pain, malaise, myalgia, ST-segment elevation, tachycardia, and tachypnea have been reported as part of postmarketing surveillance.

Side Effects by Body System

General

In general, side effects associated with mesna are few and mild. They mostly consist of bad taste, which often leads to nausea and possibly vomiting.

There are numerous side effects associated with combined ifosfamide/mesna therapy, but most of them can be attributed to ifosfamide. The following side effects are probably due to ifosfamide, and the percentages are upper limits of averages reported in literature.

Gastrointestinal

Gastrointestinal side effects are relatively common. A disturbing taste and diarrhea have been reported in up to 100% and 70% of patients, respectively. Diarrhea is not a common side effect when mesna and ifosfamide are given together. Nausea, vomiting, and abdominal discomfort have been reported in up to 33% after oral administration.

Patients should be instructed to call their doctor is they cannot tolerate their mesna.

Hypersensitivity

Mesna is not a clinically significant allergen.

Hypersensitivity side effects to this thiol (sulfur-containing) compound range from mild rashes to systemic anaphylaxis. Rare cases of vasculitides, nephritis, arthralgias, and myalgias have been reported. Limited data have revealed up to 17% of patients experience some allergic reaction to mesna, although the actual incidence in large clinical trials is much lower.

Nervous system

Nervous system side effects include headache in up to 50% and fatigue in 33% of patients. Rare cases of encephalopathy--sometimes described by confusion, drowsiness, somnolence, and generalized seizures-- have been associated with the use of ifosfamide/mesna. Neurologic toxicity has also been reported to include changes in mental status, cerebellar function, cranial nerve, and cerebellar and motor function system functions including seizures. Most experts suspect neurotoxicity from ifosfamide metabolites, but the pathogenesis remains unclear. Limited data suggest ifosfamide/mesna encephalopathy may be more likely in patients with renal insufficiency and liver disease.

Cardiovascular

Cardiovascular side effects are relatively uncommon. Hypotension has been reported in up to 17% of patients receiving orally administered mesna and ifosfamide (probably due to the ifosfamide).

Musculoskeletal

Musculoskeletal side effects include joint or limb pain in up to 50% of patients (limited data).

Metabolic

Metabolic side effects associated with the use of ifosfamide/mesna include hypokalemia.

Renal

Renal side effects include new or worsened renal insufficiency which has been reported in patients treated with ifosfamide/mesna. The nephrotoxicity was attributed to ifosfamide.

Other

Other side effects include laboratory abnormalities. Limited data have shown that mesna may cause fatal positive reactions for ketones on certain multiple reagent strips.

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