Urosaph Adverse Reactions

The most frequently occurring adverse reactions (>10%) associated with use of mesna are: Headache, infusion site reactions, abdominal pain/colic, lightheadedness, lethargy/drowsiness, pyrexia, rash, diarrhea, nausea, flushing, and influenza-like illness.
The most severe adverse reactions associated with use of mesna are: bullous skin reactions, anaphylaxis, and drug rash with eosinophilia and systemic symptoms (DRESS).
Because mesna is used in combination with oxazaphosphorines or oxazaphosphorine-containing combination chemotherapy, it is often difficult to distinguish adverse reactions that may be due to mesna from those caused by concomitantly administered cytotoxic agents.
ADR frequency is based upon the following scale: Very common (≥1/10); Common (≥1/100-<1/10), Uncommon (≥1/1,000-<1/100), Rare (≥1/10,000-<1/1,000), Very rare (<1/10,000), Unknown (adverse reactions reported in the post-marketing experience). (See Table 7.)

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Infusion site reactions: In some subjects experiencing local cutaneous infusion site reactions, subsequent exposure to mesna resulted in a cutaneous event in other areas.
Cutaneous/mucosal reactions: Cutaneous and mucosal reactions were reported to occur after both intravenous and oral mesna. These reactions included rashes, pruritus, flushing, mucosal irritation, pleuritic pain, and conjunctivitis. Approximately one-quarter of subjects with any event experienced cutaneous/mucosal reactions in conjunction with other adverse symptoms, which included, dyspnea, fever, headache, gastrointestinal symptoms, drowsiness, malaise, myalgia, and influenza-like symptoms.
Gastrointestinal reactions: Gastrointestinal reactions reported in healthy subjects included nausea, vomiting, diarrhea, abdominal pain/colic, epigastric pain/burning, constipation, and flatulence and were reported to occur after intravenous and oral mesna administration.
In vivo effect on lymphocyte counts: In pharmacokinetic studies in healthy volunteers, administration of single doses of mesna was commonly associated with a rapid (within 24 hours) and in some cases marked decrease in lymphocyte count, which was generally reversible within 1 week of administration. Data from studies with repeated dosing over several days are insufficient to characterize the time course of lymphocyte count changes under such conditions.
In vivo effect on serum phosphorus levels: In pharmacokinetic studies in healthy volunteers, administration of mesna on single or multiple days was in some cases associated with moderate transient increases in serum phosphorus concentration.
These phenomena should be considered when interpreting laboratory results.
Seek medical attention immediately at the first sign of any adverse drug reaction.