Mesnex

>10%

Nausea

Vomiting

Anorexia

Asthenia

Fatigue

Fever

Abdominal pain

Constipation

Anemia

Granulocytopenia

Leukopenia

Thrombocytopenia

Alopecia

1-10%

Anxiety

Confusion

Dizziness

Headache

Insomnia

Pain

Somnolence

Chest pain

Edema

Flushing

Tachycardia

Cough

Dyspnea

Pneumonia

Diarrhea

Hematuria

Hypokalemia

Back pain

Dehydration

Injection site reaction

Pallor

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• chest pain, trouble breathing;
• easy bruising or bleeding (nosebleeds, bleeding gums);
• anemia (low red blood cells)--pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
• low potassium--confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling.

Common side effects may include:

• nausea, vomiting, stomach pain, loss of appetite;
• constipation;
• weakness, tired feeling;
• headache, dizziness;
• increased sweating; or
• fever, chills, sore throat, cough, flu symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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.

MESNEX adverse reaction data are available from four Phase 1 studies in which single intravenous doses of 600-1200 mg MESNEX Injection without concurrent chemotherapy were administered to a total of 53 healthy volunteers and single oral doses of 600-2400 mg of MESNEX Tablets were administered to a total of 82 healthy volunteers. The most frequently reported side effects (observed in two or more healthy volunteers) for healthy volunteers receiving single doses of MESNEX 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 MESNEX Tablets alone or intravenous MESNEX followed by repeated doses of MESNEX Tablets, flatulence and rhinitis were reported. In addition, constipation was reported by healthy volunteers who had received repeated doses of intravenous MESNEX.

Additional adverse reactions in healthy volunteers receiving MESNEX 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, MESNEX was commonly associated with a rapid (within 24 hours) decrease in lymphocyte count, which was generally reversible within one week of administration.

Because MESNEX 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 MESNEX 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 MESNEX in combination with Ifosfamide-containing Regimens

Postmarketing Experience

The following adverse reactions have been reported in the postmarketing experience of patients receiving MESNEX in combination with ifosfamide or similar drugs, making it difficult to distinguish the adverse reactions which may be due to MESNEX 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

Mesnex is part of the drug class:

• Detoxifying agents for antineoplastic treatment

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Prophylaxis of Ifosfamide-induced Hemorrhagic Cystitis

Reduction in the incidence of ifosfamide-induced hemorrhagic cystitis;1 2 3 4 5 6 8 9 37 38 39 40 43 44 47 60 use recommended by ASCO.60 61 Designated an orphan drug by FDA for this use.27

Prophylaxis of Cyclophosphamide-induced Hemorrhagic Cystitis

Reduction in the incidence of hemorrhagic cystitis associated with high-dose cyclophosphamide† in bone marrow transplantation (BMT) patients;7 9 10 11 12 13 14 26 28 45 46 60 ASCO currently recommends using either mesna plus saline diuresis or forced saline diuresis for this purpose.60 61

Designated an orphan drug by FDA for inhibition of urotoxic effects of oxazaphosphorine compounds (e.g., cyclophosphamide).27

Storage

Oral

20–25°C.1

Parenteral

15–30°C.1 2 For multidose vials, may store and use for up to 8 days after initial entry.1 For preservative-free ampuls, discard unused portion.4 18

When diluted as directed (see Dilution under Dosage and Administration and also Solution Compatibility under Stability), stable at 25°C for up to 24 hours.1 2

Do not store in glass or plastic syringes with Luer-Lok fittings for >12 hours because particulates may form.4 18 53

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Oral

Mesna 20 or 50 mg/mL in flavored syrup is stable at 24°C for up to 7 days;26 mesna 1, 10, or 50 mg/mL in carbonated beverages or apple or orange juice is stable at 5°C for at least 24 hours.26

Parenteral

In the U.S.

• Mesnex

Available Dosage Forms:

• Solution

Therapeutic Class: Hemorrhagic Cystitis Inhibitor