The multi dose vials contain benzyl alcohol, which may be fatal in neonates and infants. (see Special Populations, Pediatrics) General The protective effect of UROMITEXAN (mesna) applies only to the urotoxic effects of oxazaphosphorines.
Additional prophylactic or accompanying measures recommended during treatment with oxazaphosphorines are thus not affected and should not be discontinued. UROMITEXAN is incompatible in vitro with cisplatin, carboplatin and nitrogen mustard.
The combination of an oxazaphosphorine cytostatic agent with UROMITEXAN and cisplatin, carboplatin, or nitrogen mustard in the same infusion solution is not stable and is not to be used. Mixing UROMITEXAN and epirubicin leads to inactivation of epirubicin and should be avoided.
Benzyl alcohol contained in the UROMITEXAN injection multi-dose vials can reduce the stability of cyclophosphamide and ifosfamide. Patients undergoing treatment with UROMITEXAN may experience syncope, lightheadedness, lethargy/drowsiness, dizziness, and blurred vision which could affect the ability to drive or use machines (see Drug-Lifestyle Interactions).
UROMITEXAN solution for injection contains approximately 59 mg of sodium per 400 mg mesna. Carcinogenesis and Mutagenesis See Toxicology – Mutagenicity and Carcinogenicity sections. Genitourinary UROMITEXAN does not prevent hemorrhagic cystitis in all patients.
To identify the presence of erythrocytes in the urine, microscopic evidence of red blood cells should be obtained. Patients should be monitored accordingly. Sufficient urinary output should be maintained, as required for oxazaphosphorine treatment.
Sensitivity/Resistance Hypersensitivity reactions to mesna have been reported following administration of UROMITEXAN as an uroprotectant.
These include:
Skin reactions characterized by symptoms such as localized or generalized urticaria or other forms of exanthema, pruritus, burning, angioedema and/or flushing. UROMITEXAN Product Monograph Page 5 of 24 In addition, cases of severe bullous and ulcerative skin and mucosal reactions were reported.
Some reactions were considered to be consistent with Stevens-Johnson Syndrome, toxic epidermal necrolysis, or erythema exudativum multiforme. Other reactions appeared to be consistent with a diagnosis of fixed drug eruption. Photodistribution of a rash has also been reported.
In some cases, skin reactions were accompanied by one or more other symptoms, such as fever, cardiovascular symptoms (hypotension, in some cases reported as fluid refractory, tachycardia, ECG signs consistent with perimyocarditis, hypertension; see Post-Market Adverse Drug Reactions) signs consistent with acute renal impairment, pulmonary symptoms (hypoxia, respiratory distress, bronchospasm, tachypnea, cough, bloody sputum; see Post-Market Adverse Drug Reactions) prolonged prothrombin time (PT) and partial thromboplastin time (PTT), laboratory signs of disseminated intravascular coagulopathy (DIC) hematological abnormalities (leukopenia, eosinophilia, lymphopenia, thrombocytopenia, pancytopenia; see Post-Market Adverse Drug Reactions) increased liver enzymes, nausea, vomiting, pain in the extremities, arthralgia, myalgia, malaise, stomatitis, and conjunctivitis.
Some reactions have presented as anaphylaxis. , hypotension but no skin manifestations has also been reported. Allergic reactions to mesna ranging from mild hypersensitivity to systemic anaphylactic reactions have been reported with the use of mesna in regimens to treat both severe systemic autoimmune disorders and malignancy.
Patients with autoimmune disorders who were treated with cyclophosphamide and mesna appeared to have a higher incidence of allergic reactions. In most cases, reactions occurred during or after a first treatment occasion or after several weeks of mesna exposure.
In other cases, the initial reaction was observed only after several months of exposure. In many cases, symptoms appeared on the day of exposure, with a tendency to shorter intervals following subsequent exposures. In some patients, the occurrence and/or severity of reaction appeared to vary with the dose administered.
UROMITEXAN Product Monograph Page 6 of 24 Recurrence of reactions, in some cases with increasing severity, has been reported with re- exposure. However, in some cases, a reaction did not recur with re-exposure. 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 of the potential for such reactions and that reactions may worsen with re-exposure and may in some cases be life-threatening, - be aware that 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.
, 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 (see CONTRAINDICATIONS).
Multi-dose vials:
Parenteral benzyl alcohol administration has been associated with systemic hypersensitivity reactions (see CONTRAINDICATIONS). Special […]