Urosaph Warnings

Hypersensitivity: Hypersensitivity reactions to mesna have been reported following administration of mesna as an uroprotectant. These include various skin and subcutaneous tissue symptoms.
In addition, cases of severe bullous and ulcerative skin and mucosal reactions were reported.
In some cases, skin reactions were accompanied by one or more other symptoms, such as fever, cardiovascular symptoms, pulmonary symptoms, hematological abnormalities, nausea, vomiting, pain in the extremities, arthralgia, myalgia, malaise, and conjunctivitis.
Some reactions have presented as anaphylaxis.
Fever accompanied by, e.g., hypotension but no skin manifestations has also been reported.
Some patients with a history of a reaction have shown positive delayed-type skin test results. However, a negative delayed reaction does not exclude hypersensitivity to mesna. Positive immediate-type skin test reactions have occurred in patients regardless of previous mesna exposure or history of hypersensitivity reactions, and may be related to the concentration of the mesna solution used for testing.
Prescribers should be aware that: Severe as well as minor reactions were reported with the use of mesna in regimens to treat both severe systemic autoimmune disease and malignancy and that mesna should be suspected in any hypersensitivity reaction, these reactions may occur with first exposure or after several months of exposure and in some cases can be life-threatening, the occurrence and severity of reactions appeared to vary with the dose administered with a tendency to shorter intervals following subsequent exposures, hypersensitivity reactions to mesna were interpreted to resemble the clinical picture of sepsis and, in patients with autoimmune disorders, resemble an exacerbation of the underlying disease.
Thiol Compounds: Mesna is a thiol compound, i.e., a sulfhydryl (SH) group-containing organic compound. Thiol compounds show some similarities in their adverse reaction profile, including a potential to elicit severe skin reactions. Examples of drugs that are thiol compounds include amifostine, penicillamine, and captopril.
It is not clear whether patients who experienced an adverse reaction to such a drug are at increased risk for any reactions, or similar reactions, to another thiol compound. However, when considering subsequent use of another thiol compound in such patients, the possibility of an increased risk should be taken into account.