Hospitalization and, rarely, death due to liver failure reported. Measure serum transaminase levels prior to start of treatment, monthly for the 1st 4 months of therapy, and periodically thereafter. Not recommended with ALT values >2X ULN. Obtain LFTs at the 1st signs and symptoms suggestive of liver dysfunction; immediately d/c if jaundice occurs or if ALT rises >2X ULN and closely follow-up LFTs until resolution.
OTHER BRAND NAMES
In combination with luteinizing hormone-releasing hormone (LHRH) agonists for management of locally confined Stage B2-C and Stage D2 metastatic carcinoma of the prostate.
B2-C and D2 Metastatic Prostate Carcinoma
Combination w/ LHRH Agonists:
2 caps tid at 8-hr intervals
Severe hepatic impairment.
Treatment with goserelin acetate implant for Stage B2-C prostatic carcinoma should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy. Not for use in women, particularly for nonserious or non-life-threatening conditions. Toxicities consistent with aniline exposure (eg, methemoglobinemia, hemolytic anemia, and cholestatic jaundice) observed; consider monitoring methemoglobin levels in patients susceptible to aniline toxicity (eg, with glucose-6-phosphate dehydrogenase deficiency, Hgb M disease, smokers). Gynecomastia reported together with medical castration. Regularly assess serum prostate-specific antigen (PSA) to monitor response; evaluate for clinical progression if PSA levels rise significantly and consistently during therapy, and consider treatment period free of antiandrogen while continuing LHRH analogue for patients with objective disease progression together with an elevated PSA.
Hot flashes, diarrhea, skin rash, loss of libido, impotence, cystitis, rectal bleeding, N/V, gynecomastia, proctitis, hematuria, GI disorders, anemia, leukopenia.
Increases in PT reported with long-term warfarin; closely monitor PT and may adjust anticoagulant dose.
PREGNANCY AND LACTATION
Category D, safety not known in nursing.
MECHANISM OF ACTION
Nonsteroidal antiandrogen; inhibits androgen uptake and/or inhibits nuclear binding of androgen in target tissues.
Absorption: Rapid and complete. Cmax=25.2ng/mL (geriatrics), Tmax=2 hrs (hydroxyflutamide). Distribution: Plasma protein binding (94-96%), (92-94%, hydroxyflutamide). Metabolism: Rapid and extensive via α-hydroxylation; hydroxyflutamide (active metabolite). Elimination: Urine, feces (4.2%); T1/2=6 hrs (hydroxyflutamide).
Assess for severe hepatic impairment, hypersensitivity to drug, susceptibility to aniline toxicity, and possible drug interactions. Measure serum transaminase levels.
Measure serum transaminase levels monthly for the 1st 4 months of therapy, and periodically thereafter. Obtain LFTs at the 1st signs and symptoms suggestive of liver dysfunction. Monitor methemoglobin levels in patients susceptible to aniline toxicity. Regularly monitor serum PSA.
Inform that drug is administered concomitantly with drugs used for medical castration. Advise not to interrupt dosing or d/c medications without consulting physician.
25°C (77°F); excursions permitted to 15-30°C (59-86°F).
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