Mesnex Side Effects

Generic Name: mesna

Please note - some side effects for Mesnex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Mesnex - for the Consumer

Mesnex

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 Mesnex:

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Mesnex:

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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Mesnex 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 Mesnex 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.

Seek medical attention right away if any of these SEVERE side effects occur when using Mesnex Tablets:

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 .

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Mesnex Side Effects - for the Professional

Mesnex

Mesnex adverse reaction data are available from four phase I studies in which single IV bolus doses of 600-1200 mg Mesnex Injection without concurrent chemotherapy were administered to a total of 53 subjects and single oral doses of 600-2400 mg of Mesnex Tablets were administered to a total of 82 subjects.

The most frequently reported side effects (observed in two or more patients) for patients receiving single doses of Mesnex IV were headache, injection site reactions, flushing, dizziness, nausea, vomiting, somnolence, diarrhea, anorexia, fever, pharyngitis, hyperaesthesia, influenza-like symptoms, and coughing. Among patients who received a single 1200-mg dose as an oral solution, rigors, back pain, rash, conjunctivitis, and arthralgia were also reported. In two phase I multiple-dose studies where patients received Mesnex Tablets alone or IV Mesnex followed by repeated doses of Mesnex Tablets, flatulence and rhinitis were reported. In addition, constipation was reported by patients who had received repeated doses of IV Mesnex.

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 Mesnex from those caused by the concomitantly administered cytotoxic agents.

Adverse reactions reasonably associated with mesna administered IV and orally in four controlled studies in which patients received ifosfamide or ifosfamide-containing regimens are presented in Table 3.

* All grades
Table 3
Incidence of Adverse Events and Incidence of Most Frequently Reported Adverse Events in Controlled Studies
Mesna Regimen	IV-IV-IV	IV-Oral-Oral
N exposed	119 (100.0%)	119 (100.0%)
Incidence of AEs	101 (84.9%)	106 (89.1%)
Most Frequently Reported Adverse Events (Preferred Terms)
	N (%)	N (%)
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)	9 (7.6)
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 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.

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Side Effects by Body System - for Healthcare Professionals

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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