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warnings
WARNINGS Hepatic Injury SEE WARNINGS SECTION. Use in Women Flutamide Capsules are for use only in men. This product has no indication for women, and should not be used in this population, particularly for nonserious or nonlife-threatening conditions. Fetal Toxicity Flutamide may cause fetal harm when administered to a pregnant woman (see Pregnancy ). Aniline Toxicity One metabolite of flutamide is 4-nitro-3-fluoro-methylaniline. Several toxicities consistent with aniline exposure, including methemoglobinemia, hemolytic anemia, and cholestatic jaundice have been observed in both animals and humans after flutamide administration. In patients susceptible to aniline toxicity (e.g., persons with glucose-6-phosphate dehydrogenase deficiency, hemoglobin M disease, and smokers), monitoring of methemoglobin levels should be considered.
ADVERSE REACTIONS Stage B2-C Prostatic Carcinoma Treatment with Flutamide Capsules and the goserelin acetate implant did not add substantially to the toxicity of radiation treatment alone. The following adverse experiences were reported during a multicenter clinical trial comparing flutamide + goserelin acetate implant + radiation versus radiation alone. The most frequently reported (greater than 5%) adverse experiences are listed below. Adverse Events During Acute Radiation Therapy (within first 90 days of radiation therapy) (n=231) (n=235) Goserelin acetate implant + Flutamide Capsules + Radiation Radiation Only % All % All Rectum/Large Bowel 80 76 Bladder 58 60 Skin 37 37 Adverse Events During Late Radiation Phase (after 90 days of radiation therapy) (n=231) (n=235) Goserelin Acetate Implant + Flutamide Capsules +Radiation Radiation Only % All % All Diarrhea 36 40 Cystitis 16 16 Rectal Bleeding 14 20 Proctitis 8 8 Hematuria 7 12 Additional adverse event data were collected for the combination therapy with radiation group over both the hormonal treatment and hormonal treatment plus radiation phases of the study. Adverse experiences occurring in more than 5% of patients in this group, over both parts of the study, were hot flashes (46%), diarrhea (40%), nausea (9%), and skin rash (8%). Stage D2 Metastatic Carcinoma The following adverse experiences were reported during a multicenter clinical trial comparing flutamide + LHRH-agonist versus placebo + LHRHagonist. The most frequently reported (greater than 5%) adverse experiences during treatment with Flutamide Capsules in combination with an LHRH-agonist are listed in the table below. For comparison, adverse experiences seen with an LHRH-agonist and placebo are also listed in the following table. (n=294) (n=285) Flutamide + LHRH-agonist Placebo + LHRH-agonist % All % All Hot Flashes 61 57 Loss of Libido 36 31 Impotence 33 29 Diarrhea 12 4 Nausea/Vomiting 11 10 Gynecomastia 9 11 Other 7 9 Other GI 6 4 As shown in the table, for both treatment groups, the most frequently occurring adverse experiences (hot flashes, impotence, loss of libido) were those known to be associated with low serum androgen levels and known to occur with LHRH agonists alone. The only notable difference was the higher incidence of diarrhea in the flutamide + LHRH- agonist group (12%), which was severe in 5% as opposed to the placebo + LHRH-agonist (4%), which was severe in less than 1%. In addition, the following adverse reactions were reported during treatment with flutamide + LHRH-agonist: Cardiovascular System: hypertension in 1% of patients. Central Nervous System: CNS (drowsiness /confusion / depression / anxiety / nervousness) reactions occurred in 1% of patients. Gastrointestinal System: anorexia in 4%, and other GI disorders occurred in 6% of patients. Hematopoietic System: anemia occurred in 6%, leukopenia in 3%, and thrombocytopenia in 1% of patients. Liver and Biliary System: hepatitis and jaundice in less than 1% of patients. Skin: irritation at the injection site and rash occurred in 3% of patients. Other: edema occurred in 4%, genitourinary and neuromuscular symptoms in 2%, and pulmonary symptoms in less than 1% of patients. In addition, the following spontaneous adverse experiences have been reported during the marketing of flutamide: hemolytic anemia, macrocytic anemia, methemoglobinemia, sulfhemoglobinemia, photosensitivity reactions (including erythema, ulceration, bullous eruptions, and epidermal necrolysis), and urine discoloration. The urine was noted to change to an amber or yellow-green appearance which can be attributed to the flutamide and/or its metabolites. Also reported were cholestatic jaundice, hepatic encephalopathy, and hepatic necrosis. The hepatic conditions were often reversible after discontinuing therapy; however, there have been reports of death following severe hepatic injury associated with use of flutamide. Malignant breast neoplasms have occurred rarely in male patients being treated with Flutamide Capsules. Abnormal Laboratory Test Values: Laboratory abnormalities including elevated SGOT, SGPT, bilirubin values, SGGT, BUN, and serum creatinine have been reported.