"Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.
Akman pleaded guilty in the U.S. District Court"...
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
|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)|
|Thrombocytop eni a||21 (17.6)||16 (13.4)|
|Anemia||20 (16.8)||21 (17.6)|
|Granul ocytopenia||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)|
|1Intravenous dosing of ifosfamide and MESNEX followed by either intravenous or oral doses of MESNEX according to the applicable dosage schedule. [see DOSAGE AND ADMINISTRATION].|
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.
Nervous System: Convulsion
Read the Mesnex (mesna) Side Effects Center for a complete guide to possible side effects
No clinical drug interaction studies have been conducted with MESNEX.
Last reviewed on RxList: 4/1/2014
This monograph has been modified to include the generic and brand name in many instances.
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