CASODEX is contraindicated in any patient who has shown
a hypersensitivity
reaction to the drug or any of the tablet’s components.
CASODEX has no indication for women, and should not be used
in this population, particularly for non-serious or non-life
threatening conditions. Further, CASODEX should not be used
by women who are or may become pregnant. If this drug is
used during pregnancy, or if the patient becomes pregnant
while taking this drug, the patient should be apprised of
the potential hazard to the fetus. CASODEX may cause fetal
harm when administered to pregnant women.
Hepatitis:
Rare cases of death or hospitalization due to severe liver
injury have been reported post-marketing in association
with the use of CASODEX. Hepatotoxicity in these reports
generally occurred within the first three to four months
of treatment. Hepatitis or marked increases in liver enzymes
leading to drug discontinuation
occurred in approximately 1% of CASODEX patients in controlled
clinical trials.
In clinical
trials with CASODEX as a single agent for prostate cancer,
gynecomastia and breast pain have been reported in up to
38% and 39% of patients, respectively.
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