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Two-year oral carcinogenicity studies were conducted in both male and female rats and mice at doses of 515 or 75 mg/kg/day of bicalutamideA variety of tumor target organ effects were identified and were attributed to the antiandrogenicity zentel liquid. of bicalutamidenamelytesticular benign interstitialLeydigcell tumors in male rats at all dose levelsthe steady-state plasma concentration with the 5 mg/kg/day dose is approximately 2/3 human therapeutic concentrationsand uterine adenocarcinoma in female rats at 75 mg/kg/dayapproximately 1 1/2 times the human therapeutic concentrationsThere is no evidence of Leydig cell hyperplasia in patientsuterine tumors are not relevant to the indicated patient population.
Inactive ingredientslactosemagnesium stearatehypromellosepolyethylene glycolpolyvidonesodium starch glycollatetitanium dioxide.
Genitourinary side effects are somewhat common and include nocturiahematuriaurinary tract infectionimpotenceand urinary incontinenceRef]
Quality of life was assessed with self-administered patient questionnaires on painsocial functioningemotional well-beingvitalityactivity limitationbed disabilityoverall healthphysical capacitygeneral symptomsand treatment related symptomsAssessment of the Quality of Life questionnaires did not indicate consistent significant differences between the two treatment groups.
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